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lumefantrine

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Description

Lumefantrine: A fluorene derivative that is used in combination with ARTEMETHER for the treatment of MALARIA (see ARTEMETHER-LUMEFANTRINE DRUG COMBINATION). [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

lumefantrine : A member of the class of fluorenes that is 9-(p-chlorobenzylidene)-9H-fluorene which is substitutec by chlorine at positions 2 and 7, and by a 2-(dibutylamino)-1-hydroxyethyl group at position 4. An antimalarial drug used in combination with artemether for the treatment of multi-drug resistant strains of falciparum malaria. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID6437380
CHEMBL ID38827
CHEBI ID156095
SCHEMBL ID127331
MeSH IDM0267388

Synonyms (104)

Synonym
AC-4542
lumefantrine (jan/usp/inn)
D03821
82186-77-4
lumefantrine
9h-fluorene-4-methanol, 2,7-dichloro-9-((4-chlorophenyl)methylene)-alpha-((dibutylamino)methyl)-, (z)-
dl-benflumelol
(+-)-2,7-dichloro-9-((z)-p-chlorobenzylidene)-alpha((dibutylamino)methyl)fluorene-4-methanol
benflumetol
(+-)-2,7-dichloro-9-((z)-p-chlorobenzylidene)-alpha-((dibutylamino)methyl)fluorene-4-methanol
c30h32cl3no
NCGC00167490-01
cpg-56695
benflumelol
lumefantrinum
gnf-pf-1971 ,
CHEMBL38827
(+/-)-2,7-dichloro-9-((z)-p-chlorobenzylidene)-alpha-((dibutylamino)methyl)fluorene-4-methanol
DB06708
chebi:156095 ,
2-dibutylamino-1-[2,7-dichloro-9-(4-chloro-benzylidene)-9h-fluoren-4-yl]-ethanol
2-dibutylamino-1-{2,7-dichloro-9-[1-(4-chloro-phenyl)-meth-(z)-ylidene]-9h-fluoren-4-yl}-ethanol
2-(dibutylamino)-1-[(9z)-2,7-dichloro-9-(4-chlorobenzylidene)-9h-fluoren-4-yl]ethanol
2-(dibutylamino)-1-[(9z)-2,7-dichloro-9-[(4-chlorophenyl)methylidene]fluoren-4-yl]ethanol
HMS3260F22
dtxsid3046663 ,
cas-82186-77-4
dtxcid1026663
tox21_112491
AKOS015918181
S3746
2-(dibutylamino)-1-[(9z)-2,7-dichloro-9-[(4-chlorophenyl)methylene]fluoren-4-yl]ethanol
f38r0jr742 ,
unii-f38r0jr742
lumefantrine [usan:inn:ban]
(z)-2-(dibutylamino)-1-(2,7-dichloro-9-(4-chlorobenzylidene)-9h-fluoren-4-yl)ethanol
MLS003899226
smr002543514
STL373579
coartem component lumefantrine
2-dibutylamino-1-(2,7-dichloro-9-(1-(4-chlorophenyl)meth-(z)-ylidene)-9h-fluoren-4-yl)ethanol
lumefantrine [usan]
lumefantrine [usp monograph]
lumefantrine [orange book]
lumefantrine [hsdb]
lumefantrine [usp-rs]
lumefantrine [mi]
lumefantrine [mart.]
lumefantrine [inn]
lumefantrine [who-ip]
lumefantrine [who-dd]
9h-fluorene-4-methanol, 2,7-dichloro-9-((4-chlorophenyl)methylene)-.alpha.-((dibutylamino)methyl)-, (z)-
lumefantrine [vandf]
lumefantrine component of coartem
120583-69-9
lumefantrine [jan]
lumefantrinum [who-ip latin]
(+/-)-2,7-dichloro-9-((z)-p-chlorobenzylidene)-.alpha.((dibutylamino)methyl)fluorene-4-methanol
CCG-221574
SCHEMBL127331
BBL030364
2-(dibutylamino)-1-[(9z)-2,7-dichloro-9-[(4-chlorophenyl)methylidene]-9h-fluoren-4-yl]ethan-1-ol
NCGC00167490-03
tox21_112491_1
HS-0098
tox21_500270
CS-5130
NCGC00260955-01
HY-B0803
120583-71-3
ZUV4B00D9P ,
9h-fluorene-4-methanol, 2,7-dichloro-9-((4-chlorophenyl)methylene)-.alpha.-((dibutylamino)methyl)-, (9z)-(-)-
d-benflumelol
lumefantrine, (+)-
9h-fluorene-4-methanol, 2,7-dichloro-9-((4-chlorophenyl)methylene)-.alpha.-((dibutylamino)methyl)-, (9z)-(+)-
9h-fluorene-4-methanol, 2,7-dichloro-9-((4-chlorophenyl)methylene)-.alpha.-((dibutylamino)methyl)-, (z)-(+)-
01NP22J3SV ,
120583-70-2
l-benflumelol
lumefantrine, (-)-
9h-fluorene-4-methanol, 2,7-dichloro-9-((4-chlorophenyl)methylene)-.alpha.-((dibutylamino)methyl)-, (z)-(-)-
(9z)-2,7-dichloro-9-[(4-chlorophenyl)methylene]-alpha-[(dibutylamino)methyl]-9h-fluoren-4-methanol
L0256
mfcd05662268
lumefruntrine
(9z)-2,7-dichloro-9-[(4-chlorophenyl)methylene]-alpha-[(dibutylamino)methyl]-9h-fluorene-4-methanol
lumefantrine, united states pharmacopeia (usp) reference standard
(1rs)-2-(dibutylamino)-1-[(z)-2,7-dichloro-9-(4-chlorobenzylidene)-9h-fluoren-4-yl]ethanol
unii-01np22j3sv
9h-fluorene-4-methanol, 2,7-dichloro-9-((4-chlorophenyl)methylene)-alpha-((dibutylamino)methyl)-, (z)-(-)-
unii-zuv4b00d9p
9h-fluorene-4-methanol, 2,7-dichloro-9-((4-chlorophenyl)methylene)-alpha-((dibutylamino)methyl)-, (9z)-(+)-
9h-fluorene-4-methanol, 2,7-dichloro-9-((4-chlorophenyl)methylene)-alpha-((dibutylamino)methyl)-, (9z)-(-)-
9h-fluorene-4-methanol, 2,7-dichloro-9-((4-chlorophenyl)methylene)-alpha-((dibutylamino)methyl)-, (z)-(+)-
(z)-2-(dibutylamino)-1-(2,7-dichloro-9-(4-chlorobenzylidene)-9h-fluoren-4-yl)ethan-1-ol
Q904464
AMY22191
gtpl9969
NCGC00167490-05
benflumetol, cpg-56695
9h-fluorene-4-methanol, 2,7-dichloro-9-[(4-chlorophenyl)methylene]-?-[(dibutylamino)methyl]-, (9z)- (9ci); 9h-fluorene-4-methanol, 2,7-dichloro-9-[(4-chlorophenyl)methylene]-?-[(dibutylamino)methyl]-, (z)-; benflumelol; benflumetol; lumefantrine; dl-benfl
lumefantrine for system suitability
CS-0368446
EN300-781170

Research Excerpts

Overview

Lumefantrine (benflumetol) is a fluorene derivative belonging to the aryl amino alcohol class of anti-malarial drugs. It is commercially available in fixed combination products with β-artemether.

ExcerptReferenceRelevance
"Lumefantrine (LFN) is a chiral antimalarial drug. "( Enantioselective in vitro ADME, absolute oral bioavailability, and pharmacokinetics of (-)-lumefantrine and (+)-lumefantrine in mice.
Bestha, RM; Dixit, A; Gabani, BB; Kiran, V; Mullangi, R; Narayanan, B; Srinivas, NR, 2021
)
2.28
"Lumefantrine is a long-acting antimalarial drug with an elimination half-life of over 3 days and protein binding of 99 percent. "( Strong correlation of lumefantrine concentrations in capillary and venous plasma from malaria patients.
Aweeka, FT; Forsman, C; Huang, L; Kajubi, R; Marzan, F; Mwebaza, N; Parikh, S, 2018
)
2.24
"Lumefantrine (LF) is an aryl-amino alcohol antimalarial drug used in artemisinin-based combination therapies against malaria worldwide. "( Genotoxic effects of the antimalarial drug lumefantrine in human lymphocytes in vitro and computational prediction of the mechanism associated with its interaction with DNA.
Bahia, Mde O; Bassi-Branco, CL; Batista Júnior, J; de Lucca, RM; Fontes, CJ, 2015
)
2.12
"Lumefantrine (benflumetol) is a fluorene derivative belonging to the aryl amino alcohol class of anti-malarial drugs and is commercially available in fixed combination products with β-artemether. "( Stability-indicating HPLC-DAD/UV-ESI/MS impurity profiling of the anti-malarial drug lumefantrine.
Baert, B; Burvenich, C; De Spiegeleer, B; Duchateau, L; Jansen, FH; Suleman, S; Van Dorpe, S; Vangheluwe, E; Verbeken, M, 2011
)
2.04
"Lumefantrine (LMF) is an antimalarial drug that exhibits poor oral bioavailability, owing to its poor aqueous solubility. "( Enhanced antimalarial activity of lumefantrine nanopowder prepared by wet-milling DYNO MILL technique.
Ahmad, FJ; Anwar, M; Gahoi, S; Jain, GK; Khar, RK; Pandey, SK; Singhal, M; Tripathi, R; Warsi, MH, 2012
)
2.1

Effects

Lumefantrine has a melting point of 128-131 degrees C. It is bio-transformed by cytochrome P450 isozyme 3A4 in human liver microsomes.

ExcerptReferenceRelevance
"Lumefantrine has a melting point of 128-131 degrees C. "( Experimental determination of the physicochemical properties of lumefantrine.
Adegoke, AO; Babalola, CP; Kotila, OA; Olaniyi, OO, 2013
)
2.07
"Lumefantrine has a melting point of 128-131 degrees C. "( Experimental determination of the physicochemical properties of lumefantrine.
Adegoke, AO; Babalola, CP; Kotila, OA; Olaniyi, OO, 2013
)
2.07
"Lumefantrine has been reported to be mainly bio-transformed by cytochrome P450 isozyme 3A4 to desbutyl-lumefantrine (DLF) in human liver microsomes. "( Gender differences in pharmacokinetics of lumefantrine and its metabolite desbutyl-lumefantrine in rats.
Jain, GK; Singh, SP, 2012
)
2.09

Toxicity

The main objectives of the CEM programme were to proactively determine the adverse event (AE) profile of artesunate/amodiaquine (AA) and artemether/lumefantrine (AL) in real-life settings and to find out the factors predisposing to AEs.

ExcerptReferenceRelevance
" There were no major adverse events with either drug."( Efficacy and safety of CGP 56697 (artemether and benflumetol) compared with chloroquine to treat acute falciparum malaria in Tanzanian children aged 1-5 years.
Abdulla, S; Beck, HP; Gathmann, I; Hatz, C; Kibatala, P; Mull, R; Royce, C; Schellenberg, D; Tanner, M, 1998
)
0.3
" The most commonly reported and possibly related adverse effects following A-L therapy involved the gastro-intestinal (abdominal pain, anorexia, nausea, vomiting, diarrhoea) and central nervous (headache, dizziness) systems."( An integrated assessment of the clinical safety of artemether-lumefantrine: a new oral fixed-dose combination antimalarial drug.
Alteri, E; Bakshi, R; Gathmann, I; Hermeling-Fritz, I,
)
0.37
"Proportion of treatment success and adverse drug effects that required discontinuation of treatment and/or follow-up."( Safety and efficacy of artemether-lumefantrine in the treatment of uncomplicated falciparum malaria in Ethiopia.
Argaw, D; Babaniyi, O; Jima, D; Kebede, A; Medhin, A; Tesfaye, G, 2005
)
0.61
"8) and no adverse effects or complaints related to the drug that required discontinuation of treatment or withdrawal from follow-up was reported."( Safety and efficacy of artemether-lumefantrine in the treatment of uncomplicated falciparum malaria in Ethiopia.
Argaw, D; Babaniyi, O; Jima, D; Kebede, A; Medhin, A; Tesfaye, G, 2005
)
0.61
"1%) clinical and parasitological cure for the treatment of uncomplicated falciparum malaria with no reports of adverse reaction that required withdrawal of treatment or discontinuation of follow-up."( Safety and efficacy of artemether-lumefantrine in the treatment of uncomplicated falciparum malaria in Ethiopia.
Argaw, D; Babaniyi, O; Jima, D; Kebede, A; Medhin, A; Tesfaye, G, 2005
)
0.61
" The main finding of this analysis is that the six-dose regimen of coartemether is safe and more efficacious than the four-dose regimen in children."( Efficacy and safety of the six-dose regimen of artemether-lumefantrine in pediatrics with uncomplicated Plasmodium falciparum malaria: a pooled analysis of individual patient data.
Andriano, K; De Palacios, PI; Falade, C; Hunt, P; Karbwang, J; Makanga, M; Mueller, EA; Premji, Z, 2006
)
0.58
"0%) adverse events in 849 patients assigned to pyronaridine-artesunate and 241 (57."( Efficacy and safety of a fixed-dose oral combination of pyronaridine-artesunate compared with artemether-lumefantrine in children and adults with uncomplicated Plasmodium falciparum malaria: a randomised non-inferiority trial.
Bedu-Addo, G; Bhatt, KM; Borghini-Fuhrer, I; Bustos, DG; Duparc, S; Fleckenstein, L; Gaye, O; Kayentao, K; Sesay, SS; Shin, CS; Thompson, R; Tjitra, E; Tshefu, AK, 2010
)
0.57
"The main objectives of the CEM programme were to proactively determine the adverse event (AE) profile of artesunate/amodiaquine (AA) and artemether/lumefantrine (AL) in real-life settings and to find out the factors predisposing to AEs."( Safety of Artemisinin-Based Combination Therapies in Nigeria: A Cohort Event Monitoring Study.
Adesina, O; Bassi, PU; Coulter, D; Isah, A; Jalo, I; Kalat, M; Nwoasu, SC; Nyong, EE; Osakwe, AI; Osungwu, F; Pal, S; Suku, C; Ugochukwu, C; Wallberg, M; Wammanda, RD, 2013
)
0.59
" Most adverse events occurred from day 1 and peaked by day 2 and 3 of medication with the mean duration of events being 3 days."( Safety of Artemisinin-Based Combination Therapies in Nigeria: A Cohort Event Monitoring Study.
Adesina, O; Bassi, PU; Coulter, D; Isah, A; Jalo, I; Kalat, M; Nwoasu, SC; Nyong, EE; Osakwe, AI; Osungwu, F; Pal, S; Suku, C; Ugochukwu, C; Wallberg, M; Wammanda, RD, 2013
)
0.39
"In conclusion, this pilot CEM programme suggests that adverse events with ACTs were common."( Safety of Artemisinin-Based Combination Therapies in Nigeria: A Cohort Event Monitoring Study.
Adesina, O; Bassi, PU; Coulter, D; Isah, A; Jalo, I; Kalat, M; Nwoasu, SC; Nyong, EE; Osakwe, AI; Osungwu, F; Pal, S; Suku, C; Ugochukwu, C; Wallberg, M; Wammanda, RD, 2013
)
0.39
" The primary end point was parasitological cure on day 28 while the secondary end points included: improvement in haemoglobin levels and occurrence, and severity of adverse events."( Therapeutic efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in North-Eastern Tanzania.
Buza, J; Ishengoma, DS; Lemnge, MM; Mandara, CI; Shahada, F; Shayo, A, 2014
)
0.66
" Reported adverse events included cough (49."( Therapeutic efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in North-Eastern Tanzania.
Buza, J; Ishengoma, DS; Lemnge, MM; Mandara, CI; Shahada, F; Shayo, A, 2014
)
0.66
" Adverse events though common were similar between treatment arms and mostly related to the disease."( Efficacy and safety of fixed-dose artesunate-amodiaquine vs. artemether-lumefantrine for repeated treatment of uncomplicated malaria in Ugandan children.
Afizi, K; Fredrick, M; Kamya, MR; Lameyre, V; Lukwago, R; Talisuna, AO; Yeka, A, 2014
)
0.63
"Plasmodium falciparum sporozite (PfSPZ) Vaccine is a metabolically active, non-replicating, whole malaria sporozoite vaccine that has been reported to be safe and protective against P falciparum controlled human malaria infection in malaria-naive individuals."( Safety and efficacy of PfSPZ Vaccine against Plasmodium falciparum via direct venous inoculation in healthy malaria-exposed adults in Mali: a randomised, double-blind phase 1 trial.
Abebe, Y; Billingsley, PF; Chakravarty, S; Diallo, H; Ding, K; Dolo, A; Doumbo, O; Duffy, PE; Fay, MP; Gabriel, EE; Guindo, MA; Gunasekera, A; Healy, SA; Hoffman, SL; James, ER; Kamate, B; Katile, A; Li, M; Manoj, A; Murshedkar, T; Niangaly, A; Niaré, K; Nutman, TB; O'Connell, EM; Omaswa, F; Richie, TL; Ruben, AJ; Samake, Y; Sim, BKL; Sissoko, K; Sissoko, MS; Thera, I; Walther, M; Wong-Madden, S; Zaidi, I; Zeguime, A, 2017
)
0.46
" We detected no significant differences in local or systemic adverse events or laboratory abnormalities between the PfSPZ Vaccine and placebo groups, and only grade 1 (mild) local or systemic adverse events occurred in both groups."( Safety and efficacy of PfSPZ Vaccine against Plasmodium falciparum via direct venous inoculation in healthy malaria-exposed adults in Mali: a randomised, double-blind phase 1 trial.
Abebe, Y; Billingsley, PF; Chakravarty, S; Diallo, H; Ding, K; Dolo, A; Doumbo, O; Duffy, PE; Fay, MP; Gabriel, EE; Guindo, MA; Gunasekera, A; Healy, SA; Hoffman, SL; James, ER; Kamate, B; Katile, A; Li, M; Manoj, A; Murshedkar, T; Niangaly, A; Niaré, K; Nutman, TB; O'Connell, EM; Omaswa, F; Richie, TL; Ruben, AJ; Samake, Y; Sim, BKL; Sissoko, K; Sissoko, MS; Thera, I; Walther, M; Wong-Madden, S; Zaidi, I; Zeguime, A, 2017
)
0.46
" Day 7 lumefantrine concentrations and the number and nature of adverse events were similar between study arms; only one serious adverse event occurred (renal impairment in the no primaquine arm)."( Safety and tolerability of single low-dose primaquine in a low-intensity transmission area in South Africa: an open-label, randomized controlled trial.
Allen, E; Barnes, KI; Frean, J; Mabuza, A; Malatje, G; Raman, J; Swanepoel, H; Wiesner, L; Workman, L, 2019
)
0.97
"0%) patients experienced at least one drug-related adverse event (AE)."( Safety and tolerability of artesunate-amodiaquine, artemether-lumefantrine and quinine plus clindamycin in the treatment of uncomplicated Plasmodium falciparum malaria in Kinshasa, the Democratic Republic of the Congo.
Fungula, B; Inocencio da Luz, R; Kalabuanga, M; Lula Ntamba, Y; Lutumba, P; Muhindo Mavoko, H; Ntamabyaliro Nsengi, PM; Tona Lutete, G; Van Geertruyden, JP, 2019
)
0.75

Pharmacokinetics

The pharmacokinetic parameters of tafenoquine, piperaquine, lumefantrine, artemether, and dihydroartemisinin were determined by using noncompartmental methods. A validated method was successfully applied to determine the plasma concentrations ofArtemether and lumefanrine in healthy volunteers over the course of 11 days.

ExcerptReferenceRelevance
"To investigate the pharmacokinetic and pharmacodynamic properties of artemether and benflumetol in a fixed combination tablet (CGP 56697) and to offer an explanation for the lower than expected cure rate in a Thai clinical trial."( Population pharmacokinetics and therapeutic response of CGP 56697 (artemether + benflumetol) in malaria patients.
Ezzet, F; Karbwang, J; Mull, R, 1998
)
0.3
" Parasite clearance time and 28 day cure rate were correlated with the derived pharmacokinetic parameters."( Population pharmacokinetics and therapeutic response of CGP 56697 (artemether + benflumetol) in malaria patients.
Ezzet, F; Karbwang, J; Mull, R, 1998
)
0.3
"Using a population-based approach it was confirmed that the pharmacokinetic and pharmacodynamic properties of benflumetol and artemether differ markedly."( Population pharmacokinetics and therapeutic response of CGP 56697 (artemether + benflumetol) in malaria patients.
Ezzet, F; Karbwang, J; Mull, R, 1998
)
0.3
" The pharmacokinetics of benflumetol were highly variable, with coefficients of variation in pharmacokinetic parameters ranging from 14."( Pharmacokinetics of benflumetol given as a fixed combination artemether-benflumetol (CGP 56697) in Thai patients with uncomplicated falciparum malaria.
Farkad, E; Karbwang, J; Mull, R; Na-Bangchang, K; Tasanor, U; Thanavibul, A, 1999
)
0.3
"The objective of this study was to conduct a prospective population pharmacokinetic and pharmacodynamic evaluation of lumefantrine during blinded comparisons of artemether-lumefantrine treatment regimens in uncomplicated multidrug-resistant falciparum malaria."( Pharmacokinetics and pharmacodynamics of lumefantrine (benflumetol) in acute falciparum malaria.
Ezzet, F; Looareesuwan, S; Nosten, F; van Vugt, M; White, NJ, 2000
)
0.78
"To evaluate whether the potent CYP3A4 inhibitor ketoconazole has any influence on the pharmacokinetic and electrocardiographic parameters of the antimalarial co-artemether (artemether-lumefantrine) in healthy subjects."( Pharmacokinetics and electrocardiographic pharmacodynamics of artemether-lumefantrine (Riamet) with concomitant administration of ketoconazole in healthy subjects.
Carpenter, P; Lefèvre, G; McClean, M; Schmidli, H; Souppart, C; Stypinski, D, 2002
)
0.74
"A six-dose antimalarial regimen of artemether-lumefantrine (A/L) may soon become one of the most widely used drug combination in Africa, despite possible constraints with adherence and poor absorption due to inadequate nutrition, and a lack of pharmacokinetic and effectiveness data."( Supervised versus unsupervised antimalarial treatment with six-dose artemether-lumefantrine: pharmacokinetic and dosage-related findings from a clinical trial in Uganda.
Babigumira, J; Bajunirwe, F; Biraro, S; Checchi, F; Ferradini, L; Fogg, C; Grandesso, F; Guthmann, JP; Kigozi, I; Kiguli, J; Kyomuhendo, J; Piola, P; Ruzagira, E; Taylor, WR, 2006
)
0.82
"To determine the pharmacokinetic properties of artemether and lumefantrine (AL) in pregnant women with recrudescent uncomplicated multi-drug resistant falciparum malaria."( The pharmacokinetics of artemether and lumefantrine in pregnant women with uncomplicated falciparum malaria.
Ashley, EA; La, Y; Lindegardh, N; McGready, R; Nosten, F; Singhasivanon, P; Stepniewska, K; White, NJ, 2006
)
0.84
" Serial blood samples were taken over a 7-day period, and pharmacokinetic parameters were estimated."( The pharmacokinetics of artemether and lumefantrine in pregnant women with uncomplicated falciparum malaria.
Ashley, EA; La, Y; Lindegardh, N; McGready, R; Nosten, F; Singhasivanon, P; Stepniewska, K; White, NJ, 2006
)
0.6
"Lumefantrine pharmacokinetic profiles were obtained for 36 patients."( Pharmacokinetic study of artemether-lumefantrine given once daily for the treatment of uncomplicated multidrug-resistant falciparum malaria.
Annerberg, A; Ashley, EA; Brockman, A; Hla, G; Hutagalung, R; Lindegårdh, N; McGready, R; Nosten, F; Proux, S; Singhasivanon, P; Singtoroj, T; Stepniewska, K; White, NJ; Wilahphaingern, J, 2007
)
2.06
" The method was successfully applied for the pharmacokinetic study in rats."( Determination of lumefantrine in rat plasma by liquid-liquid extraction using LC-MS/MS with electrospray ionization: assay development, validation and application to a pharmacokinetic study.
Jain, GK; Singh, SP, 2009
)
0.69
" For artemether, trends toward Cmax and AUC decreases (Cmax 14."( Lopinavir/ritonavir affects pharmacokinetic exposure of artemether/lumefantrine in HIV-uninfected healthy volunteers.
Aweeka, FT; Charlebois, E; Dorsey, G; German, P; Hanpithakpong, W; Havlir, D; Lawrence, J; Lindegardh, N; Parikh, S; Rosenthal, PJ, 2009
)
0.59
" The objective of this study was to determine the population pharmacokinetic properties of lumefantrine in pregnant women with uncomplicated multidrug-resistant Plasmodium falciparum malaria on the northwestern border of Thailand."( Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
Annerberg, A; Ashley, EA; Day, NP; Kamanikom, B; Lindegardh, N; McGready, R; Nosten, F; Pimanpanarak, M; Singhasivanon, P; Stepniewska, K; Tarning, J; White, NJ, 2009
)
0.86
" Pharmacokinetic (PK) data informing the optimum dosing of these drug regimens is limited, especially in children."( Pharmacokinetics of artemether-lumefantrine and artesunate-amodiaquine in children in Kampala, Uganda.
Annerberg, A; Aweeka, F; Clark, TD; Dorsey, G; Drysdale, T; German, P; Kalyango, JN; Kamya, MR; Lindegardh, N; McGee, B; Mwesigwa, J; Parikh, S; Rosenthal, PJ, 2010
)
0.65
" The validated method was successfully applied to determine the plasma concentrations of artemether and lumefantrine in healthy volunteers, in a one-dose pharmacokinetic study, over the course of 11 days."( Liquid chromatography-tandem mass spectrometry for the simultaneous quantitation of artemether and lumefantrine in human plasma: application for a pharmacokinetic study.
Bellorio, KB; César, IC; Chellini, PR; de Abreu, FC; Moreira, JM; Pianetti, GA; Ribeiro, JA; Teixeira, Lde S, 2011
)
0.8
"The pharmacodynamic interaction between lumefantrine and monodesbutyl-benflumetol has been investigated in 44 fresh isolates of patients with a Plasmodium falciparum infection from the region of Mae Sot (Thailand)."( Pharmacodynamic interaction between lumefantrine and desbutyl-benflumetol in Plasmodium falciparum in vitro.
Congpuong, K; Leeb, A; Satimai, W; Wernsdorfer, G; Wernsdorfer, WH; Wiedermann, U, 2010
)
0.9
"The pharmacokinetic and pharmacodynamic properties of a new pediatric formulation of artemether-lumefantrine, dispersible tablet, were determined within the context of a multicenter, randomized, parallel-group study."( Pharmacokinetic and pharmacodynamic characteristics of a new pediatric formulation of artemether-lumefantrine in African children with uncomplicated Plasmodium falciparum malaria.
Abdulla, S; Bassat, Q; Borrmann, S; Djimdé, AA; Lefèvre, G; Lyimo, J; Mandomando, I; Tekete, M, 2011
)
0.8
"There are sparse published data relating to the pharmacokinetic properties of artemether, lumefantrine, and their active metabolites in children, especially desbutyl-lumefantrine."( Population pharmacokinetics of artemether, lumefantrine, and their respective metabolites in Papua New Guinean children with uncomplicated malaria.
Davis, TM; Griffin, S; Ilett, KF; Kose, K; Mueller, I; Page-Sharp, M; Salman, S; Siba, PM, 2011
)
0.85
" Identified articles were included in the review if the study had at least one group that reported at least one pharmacokinetic parameter of interest in pregnant women."( Pharmacokinetics of antimalarials in pregnancy: a systematic review.
Ensom, MH; Wilby, KJ, 2011
)
0.37
"The pharmacokinetic parameters of lumefantrine and its metabolite desbutyl-lumefantrine were successfully determined in rats for the first time."( Intravenous pharmacokinetics, oral bioavailability, dose proportionality and in situ permeability of anti-malarial lumefantrine in rats.
Jain, GK; Nafis, A; Puri, SK; Raju, KS; Singh, SP, 2011
)
0.86
" Pregnancy has been reported to alter the pharmacokinetic properties of many anti-malarial drugs."( Population pharmacokinetics of Artemether and dihydroartemisinin in pregnant women with uncomplicated Plasmodium falciparum malaria in Uganda.
Day, NP; Dhorda, M; Guerin, PJ; Kloprogge, F; Lindegardh, N; Muwanga, S; Nosten, F; Nuengchamnong, N; Piola, P; Tarning, J; Turyakira, E; White, NJ, 2012
)
0.38
" A simultaneous drug-metabolite population pharmacokinetic model for artemether and dihydroartemisinin was developed taking into account different disposition, absorption, error and covariate models."( Population pharmacokinetics of Artemether and dihydroartemisinin in pregnant women with uncomplicated Plasmodium falciparum malaria in Uganda.
Day, NP; Dhorda, M; Guerin, PJ; Kloprogge, F; Lindegardh, N; Muwanga, S; Nosten, F; Nuengchamnong, N; Piola, P; Tarning, J; Turyakira, E; White, NJ, 2012
)
0.38
" The objective was to investigate pharmacokinetic interactions between darunavir/ritonavir or etravirine and arthemether/lumefrantrine."( Pharmacokinetic interaction between etravirine or darunavir/ritonavir and artemether/lumefantrine in healthy volunteers: a two-panel, two-way, two-period, randomized trial.
DeMasi, R; Kakuda, TN; Mohammed, P; van Delft, Y, 2013
)
0.61
"Pregnancy alters the pharmacokinetic properties of many drugs used in the treatment of malaria, usually resulting in lower drug exposures."( Pharmacokinetic properties of artemether, dihydroartemisinin, lumefantrine, and quinine in pregnant women with uncomplicated plasmodium falciparum malaria in Uganda.
Dhorda, M; Guerin, PJ; Jullien, V; Kloprogge, F; Nosten, F; Piola, P; Tarning, J; White, NJ, 2013
)
0.63
" The effect of EFV and/or NVP on lumefantrine pharmacokinetic profile among HIV-malaria co-infected patients on ART and treated with AL was investigated."( The influence of nevirapine and efavirenz-based anti-retroviral therapy on the pharmacokinetics of lumefantrine and anti-malarial dose recommendation in HIV-malaria co-treatment.
Aklillu, E; Kamuhabwa, AA; Maganda, BA; Minzi, OM; Ngaimisi, E, 2015
)
0.91
" Pharmacokinetic analysis of lumefantrine was done using non-linear mixed effect modelling."( The influence of nevirapine and efavirenz-based anti-retroviral therapy on the pharmacokinetics of lumefantrine and anti-malarial dose recommendation in HIV-malaria co-treatment.
Aklillu, E; Kamuhabwa, AA; Maganda, BA; Minzi, OM; Ngaimisi, E, 2015
)
0.92
"Of the evaluated models, a two-compartment pharmacokinetic model with first order absorption and lag-time described well lumefantrine plasma concentrations time profile."( The influence of nevirapine and efavirenz-based anti-retroviral therapy on the pharmacokinetics of lumefantrine and anti-malarial dose recommendation in HIV-malaria co-treatment.
Aklillu, E; Kamuhabwa, AA; Maganda, BA; Minzi, OM; Ngaimisi, E, 2015
)
0.84
" A simultaneous pharmacokinetic drug-metabolite model was developed based on dense venous and sparse capillary lumefantrine and desbutyl-lumefantrine plasma samples from 116 pregnant patients on the Thailand-Myanmar border."( Lumefantrine and Desbutyl-Lumefantrine Population Pharmacokinetic-Pharmacodynamic Relationships in Pregnant Women with Uncomplicated Plasmodium falciparum Malaria on the Thailand-Myanmar Border.
Blessborn, D; Day, NP; Hanpithakpong, W; Kloprogge, F; McGready, R; Nosten, F; Tarning, J; White, NJ, 2015
)
2.07
"The pharmacokinetic compatibility of short-acting CDRI candidate antimalarial trioxane derivative, 99-411, was tested with long-acting prescription antimalarials, lumefantrine and piperaquine."( Assessment of pharmacokinetic compatibility of short acting CDRI candidate trioxane derivative, 99-411, with long acting prescription antimalarials, lumefantrine and piperaquine.
Raju, KS; Singh, SP; Taneja, I; Wahajuddin, M, 2015
)
0.81
" The observation of a shorter terminal half-life for lumefantrine may have contributed to a higher frequency of reinfection or a shorter posttreatment prophylactic period in pregnant women than in nonpregnant adults."( Artemether-Lumefantrine Pharmacokinetics and Clinical Response Are Minimally Altered in Pregnant Ugandan Women Treated for Uncomplicated Falciparum Malaria.
Achan, J; Aweeka, F; Huang, L; Kajubi, R; Kiconco, S; Mwebaza, N; Mwima, MW; Nguyen, VK; Nyunt, MM; Parikh, S; Ssebuliba, J, 2015
)
1.06
" The pharmacokinetic parameters of tafenoquine, piperaquine, lumefantrine, artemether, and dihydroartemisinin were determined by using noncompartmental methods."( Pharmacokinetic Interactions between Tafenoquine and Dihydroartemisinin-Piperaquine or Artemether-Lumefantrine in Healthy Adult Subjects.
Bouhired, S; Duparc, S; Goyal, N; Green, JA; Hussaini, A; Jones, SW; Koh, GC; Kostov, I; Mohamed, K; Taylor, M; Wolstenholm, A, 2016
)
0.89
"Pregnancy has considerable effects on the pharmacokinetic properties of drugs used to treat uncomplicated Plasmodium falciparum malaria."( Effect of pharmacogenetics on plasma lumefantrine pharmacokinetics and malaria treatment outcome in pregnant women.
Aklillu, E; Asghar, M; Färnert, A; Homann, MV; Kamuhabwa, AAR; Massawe, SN; Minzi, OMS; Mutagonda, RF, 2017
)
0.73
" Pharmacokinetic parameters (area under the plasma concentration vs."( Concomitant nevirapine impacts pharmacokinetic exposure to the antimalarial artemether-lumefantrine in African children.
Aweeka, FT; Barlow-Mosha, L; Carey, V; Gingrich, D; Graham, B; Huang, L; Kamthunzi, P; Lindsey, JC; Marzan, F; Nachman, S; Parikh, S; Ssemambo, PK, 2017
)
0.68
" Fifteen of the 16 (aged 4 to 11 years) on nevirapine-based ART were included in the pharmacokinetic analysis."( Concomitant nevirapine impacts pharmacokinetic exposure to the antimalarial artemether-lumefantrine in African children.
Aweeka, FT; Barlow-Mosha, L; Carey, V; Gingrich, D; Graham, B; Huang, L; Kamthunzi, P; Lindsey, JC; Marzan, F; Nachman, S; Parikh, S; Ssemambo, PK, 2017
)
0.68
" A population pharmacokinetic meta-analysis was conducted using individual participant data from 10 studies with 6,100 lumefantrine concentrations from 793 nonpregnant adult participants (41% HIV-malaria-coinfected, 36% malaria-infected, 20% HIV-infected, and 3% healthy volunteers)."( An Individual Participant Data Population Pharmacokinetic Meta-analysis of Drug-Drug Interactions between Lumefantrine and Commonly Used Antiretroviral Treatment.
Aweeka, FT; Barnes, KI; Byakika-Kibwika, P; Bygbjerg, IC; Chijioke-Nwauche, I; Denti, P; Francis, J; Hoglund, RM; Khoo, SH; Kredo, T; Lamorde, M; Lemnge, MM; Merry, C; Nyagonde, N; Parikh, S; Scarsi, KK; Sutherland, CJ; Tarning, J; Vestergaard, LS; Walimbwa, SI; Workman, L, 2020
)
0.98
" The pharmacokinetic results indicated that the disposition of LFN enantiomers was stereoselective in mice."( Enantioselective LC-ESI-MS/MS method for quantitation of (-)-lumefantrine and (+)-lumefantrine in mice plasma and application to a pharmacokinetic study.
Bajantri, M; Balaji, N; Chandran, R; Dixit, A; Gabani, BB; Kiran, V; Mullangi, R; Srinivas, NR, 2020
)
0.8
"The aim of this study was to assess the pharmacokinetic properties of artemether, lumefantrine and their active metabolites in Plasmodium knowlesi malaria."( The pharmacokinetic properties of artemether and lumefantrine in Malaysian patients with Plasmodium knowlesi malaria.
Davis, TME; Davis, WA; Hii, KC; Page-Sharp, M; Salman, S; Singh, B; Sugiarto, SR, 2022
)
1.2
" Multi-compartmental population pharmacokinetic models were developed using plasma with or without DBS drug concentrations."( The pharmacokinetic properties of artemether and lumefantrine in Malaysian patients with Plasmodium knowlesi malaria.
Davis, TME; Davis, WA; Hii, KC; Page-Sharp, M; Salman, S; Singh, B; Sugiarto, SR, 2022
)
0.98
" DBS lumefantrine concentrations can be used in pharmacokinetic studies but DBS technology is currently unreliable for the other analytes."( The pharmacokinetic properties of artemether and lumefantrine in Malaysian patients with Plasmodium knowlesi malaria.
Davis, TME; Davis, WA; Hii, KC; Page-Sharp, M; Salman, S; Singh, B; Sugiarto, SR, 2022
)
1.49

Compound-Compound Interactions

ExcerptReferenceRelevance
" Of these 16 new anilides administered orally as one 6 mg/kg dose combined with 18 mg/kg mefloquine hydrochloride, only sulfide 3-arteSanilide 12d was completely curative: on day 30 after infection, all mice in this group had no detectable parasitemia, gained as much weight as the uninfected control mice, and behaved normally."( Malaria-infected mice are completely cured by one 6 mg/kg oral dose of a new monomeric trioxane sulfide combined with mefloquine.
Girdwood, SC; Mott, BT; Nenortas, E; Posner, GH; Shapiro, TA; Slack, RD; Sullivan, D; Tripathi, A; Triphati, A; Woodard, LE, 2012
)
0.38
" We undertook two pharmacokinetic studies in healthy volunteers, using standard adult doses of artemether-lumefantrine or artesunate-amodiaquine given with 50 mg once daily dolutegravir (DTG) to investigate the drug-drug interaction between artemether-lumefantrine or artesunate-amodiaquine and dolutegravir."( Drug Interactions between Dolutegravir and Artemether-Lumefantrine or Artesunate-Amodiaquine.
Amara, A; Byakika-Kibwika, P; Chiong, J; Else, L; Gini, J; Kaboggoza, J; Khoo, SH; Lamorde, M; Tarning, J; Waitt, C; Walimbwa, SI; Winterberg, M, 2019
)
0.98
"Treating malaria in HIV-coinfected individuals should consider potential drug-drug interactions."( An Individual Participant Data Population Pharmacokinetic Meta-analysis of Drug-Drug Interactions between Lumefantrine and Commonly Used Antiretroviral Treatment.
Aweeka, FT; Barnes, KI; Byakika-Kibwika, P; Bygbjerg, IC; Chijioke-Nwauche, I; Denti, P; Francis, J; Hoglund, RM; Khoo, SH; Kredo, T; Lamorde, M; Lemnge, MM; Merry, C; Nyagonde, N; Parikh, S; Scarsi, KK; Sutherland, CJ; Tarning, J; Vestergaard, LS; Walimbwa, SI; Workman, L, 2020
)
0.77

Bioavailability

Lumefantrine is an anti-malaria drug that was processed into 200 nm nanoparticles with enhanced bioavailability and dissolution kinetics. Consumption of milk increased model-estimated lumefanrine bioavailability by 57% (90% CI: 29-96%) with crushed tablets compared to no food.

ExcerptReferenceRelevance
" The variability in bioavailability of artemether and dihydroartemisinin was large both between doses and between patients, but was less pronounced for benflumetol."( Population pharmacokinetics and therapeutic response of CGP 56697 (artemether + benflumetol) in malaria patients.
Ezzet, F; Karbwang, J; Mull, R, 1998
)
0.3
" Lumefantrine could be estimated accurately enough to assess bioavailability and treatment compliance on day 7 (i."( Development and validation of an automated solid-phase extraction and liquid chromatographic method for determination of lumefantrine in capillary blood on sampling paper.
Annerberg, A; Bergqvist, Y; Björkman, A; Blessborn, D; Lindegardh, N; Römsing, S; Sundquist, D, 2007
)
1.46
" Therefore, we evaluated the effect of food intake on oral lumefantrine bioavailability in African children with malaria."( The effect of food consumption on lumefantrine bioavailability in African children receiving artemether-lumefantrine crushed or dispersible tablets (Coartem) for acute uncomplicated Plasmodium falciparum malaria.
Björkman, A; Borrmann, S; D'Alessandro, U; Djimdé, A; González, R; Hamel, M; Juma, E; Kern, SE; Lefèvre, G; Machevo, S; Marrast, AC; Mårtensson, A; Ogutu, B; Peshu, J; Sallas, WM, 2010
)
0.88
" Similarly, consumption of milk (the most common meal) increased model-estimated lumefantrine bioavailability by 57% (90% CI: 29-96%) with crushed tablets and 65% (90% CI: 28-109%) with dispersible tablets compared to no food."( The effect of food consumption on lumefantrine bioavailability in African children receiving artemether-lumefantrine crushed or dispersible tablets (Coartem) for acute uncomplicated Plasmodium falciparum malaria.
Björkman, A; Borrmann, S; D'Alessandro, U; Djimdé, A; González, R; Hamel, M; Juma, E; Kern, SE; Lefèvre, G; Machevo, S; Marrast, AC; Mårtensson, A; Ogutu, B; Peshu, J; Sallas, WM, 2010
)
0.87
" Although artemether bioavailability was variable and its clearance increased by 67."( Population pharmacokinetics of artemether, lumefantrine, and their respective metabolites in Papua New Guinean children with uncomplicated malaria.
Davis, TM; Griffin, S; Ilett, KF; Kose, K; Mueller, I; Page-Sharp, M; Salman, S; Siba, PM, 2011
)
0.63
"5 mg/kg dose following administration through the lateral tail vein in order to obtain the absolute oral bioavailability and clearance parameters."( Intravenous pharmacokinetics, oral bioavailability, dose proportionality and in situ permeability of anti-malarial lumefantrine in rats.
Jain, GK; Nafis, A; Puri, SK; Raju, KS; Singh, SP, 2011
)
0.58
" The absolute oral bioavailability of lumefantrine was found to be dose dependent."( Intravenous pharmacokinetics, oral bioavailability, dose proportionality and in situ permeability of anti-malarial lumefantrine in rats.
Jain, GK; Nafis, A; Puri, SK; Raju, KS; Singh, SP, 2011
)
0.85
" The orally bioavailable lead imidazolopiperazine confers complete causal prophylactic protection (15 milligrams/kilogram) in rodent models of malaria and shows potent in vivo blood-stage therapeutic activity."( Imaging of Plasmodium liver stages to drive next-generation antimalarial drug discovery.
Barnes, SW; Bonamy, GM; Bopp, SE; Borboa, R; Bright, AT; Chatterjee, A; Che, J; Cohen, S; Dharia, NV; Diagana, TT; Fidock, DA; Froissard, P; Gagaring, K; Gettayacamin, M; Glynne, RJ; Gordon, P; Groessl, T; Kato, N; Kuhen, KL; Lee, MC; Mazier, D; McNamara, CW; Meister, S; Nagle, A; Nam, TG; Plouffe, DM; Richmond, W; Roland, J; Rottmann, M; Sattabongkot, J; Schultz, PG; Tuntland, T; Walker, JR; Winzeler, EA; Wu, T; Zhou, B; Zhou, Y, 2011
)
0.37
"The objective of this study was to compare different methods of adjusted indirect comparisons that can be used to investigate the relative bioavailability of different generic products."( Statistical approaches to indirectly compare bioequivalence between generics: a comparison of methodologies employing artemether/lumefantrine 20/120 mg tablets as prequalified by WHO.
García-Arieta, A; Gordon, J; Gwaza, L; Hansson, H; Potthast, H; Stahl, M; Welink, J, 2012
)
0.58
"Data from three bioequivalence studies conducted independently that compared three generics with the same reference product were used to indirectly determine the relative bioavailability between the generics themselves."( Statistical approaches to indirectly compare bioequivalence between generics: a comparison of methodologies employing artemether/lumefantrine 20/120 mg tablets as prequalified by WHO.
García-Arieta, A; Gordon, J; Gwaza, L; Hansson, H; Potthast, H; Stahl, M; Welink, J, 2012
)
0.58
"Existence of anti-malarial generic drugs with low bioavailability marketed on sub-Saharan Africa raises a concern on patients achieving therapeutic concentrations after intake of such products."( Comparison of bioavailability between the most available generic tablet formulation containing artemether and lumefantrine on the Tanzanian market and the innovator's product.
Abdulla, S; Chemba, M; Juma, O; Marealle, IA; Minzi, OM; Ngaimisi, E; Rutaihwa, M; Sasi, P; Shekalaghe, S, 2013
)
0.6
" The most widely available generic (Artefan®, Ajanta Pharma Ltd, Maharashtra, India) was sampled for bioavailability comparison with Coartem® (Novartis Pharma, Basel, Switzerland)--the innovator's product."( Comparison of bioavailability between the most available generic tablet formulation containing artemether and lumefantrine on the Tanzanian market and the innovator's product.
Abdulla, S; Chemba, M; Juma, O; Marealle, IA; Minzi, OM; Ngaimisi, E; Rutaihwa, M; Sasi, P; Shekalaghe, S, 2013
)
0.6
"In the quest to explore the reason for the low and variable bioavailability of lumefantrine, we investigated the possible role of P-glycoprotein (P-gp) in lumefantrine intestinal absorption."( Investigation of the functional role of P-glycoprotein in limiting the oral bioavailability of lumefantrine.
Raju, KS; Singh, SP; Taneja, I, 2014
)
0.85
" Upon coadministration of 97-78, the relative bioavailability of lumefantrine significantly decreased to 64."( Simultaneous quantification of proposed anti-malarial combination comprising of lumefantrine and CDRI 97-78 in rat plasma using the HPLC-ESI-MS/MS method: application to drug interaction study.
Gayen, JR; Raju, KS; Siddiqui, HH; Singh, SK; Singh, SP; Taneja, I; Wahajuddin, M, 2015
)
0.88
" Patients in the EFV-arm but not in the NVP-arm had significantly lower lumefantrine bioavailability compared to that in the control-arm."( The influence of nevirapine and efavirenz-based anti-retroviral therapy on the pharmacokinetics of lumefantrine and anti-malarial dose recommendation in HIV-malaria co-treatment.
Aklillu, E; Kamuhabwa, AA; Maganda, BA; Minzi, OM; Ngaimisi, E, 2015
)
0.87
"Co-treatment of AL with EFV-based ART but not NVP-based ART significantly reduces lumefantrine bioavailability and consequently total exposure."( The influence of nevirapine and efavirenz-based anti-retroviral therapy on the pharmacokinetics of lumefantrine and anti-malarial dose recommendation in HIV-malaria co-treatment.
Aklillu, E; Kamuhabwa, AA; Maganda, BA; Minzi, OM; Ngaimisi, E, 2015
)
0.86
" In previous studies we reported on the ability of Pheroid vesicles to improve the bioavailability of poorly soluble drugs."( In vivo efficacy and bioavailability of lumefantrine: Evaluating the application of Pheroid technology.
Denti, P; du Plessis, LH; Govender, K; Wiesner, L, 2015
)
0.68
"Oral delivery and bioavailability of artemether and lumefantrine could be improved using SRMS-based SLMs."( Formulation design, in vitro characterizations and anti-malarial investigations of artemether and lumefantrine-entrapped solid lipid microparticles.
Agbo, C; Agubata, O; Attama, A; Chime, S; Kenechukwu, F; Lovelyn, C; Ofokansi, K; Ogbonna, J; Umeyor, C, 2016
)
0.9
" Age had a significant positive correlation with bioavailability in a model that included allometric scaling."( Population Pharmacokinetics and Pharmacodynamics of Lumefantrine in Young Ugandan Children Treated With Artemether-Lumefantrine for Uncomplicated Malaria.
Arinaitwe, E; Aweeka, FT; Bergqvist, Y; Bigira, V; Blessborn, D; Creek, DJ; Kakuru, A; McCormack, SA; Muhindo, M; Parikh, S; Sambol, NC; Sukumar, N; Tappero, JW; Tchaparian, E; Wanzira, H, 2016
)
0.68
" In an attempt to enhance the bioavailability of lumefantrine, new solid dispersion formulations (SDF) were developed, and the pharmacokinetics of two SDF variants were assessed in a randomized, open-label, sequential two-part study in healthy volunteers."( Bioavailability of Lumefantrine Is Significantly Enhanced with a Novel Formulation Approach, an Outcome from a Randomized, Open-Label Pharmacokinetic Study in Healthy Volunteers.
Chen, L; Jain, JP; Kalluri, S; Koradia, V; Kota, J; Leong, FJ; Stein, DS; Sunkara, G; Wolf, MC, 2017
)
1.04
" Lumefantrine, an anti-malaria drug, was chosen as a representative drug that was processed into 200 nm nanoparticles with enhanced bioavailability and dissolution kinetics."( Translational formulation of nanoparticle therapeutics from laboratory discovery to clinical scale.
Armstrong, M; Feng, J; Markwalter, CE; Prud'homme, RK; Tian, C, 2019
)
1.42
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" Herein, the amorphous solid dispersions (SD) of lumefantrine (LUMF) containing piperine (PIP), a P-gp and CYP3A4 inhibitor, were formulated with Soluplus (Sol), Klucel (Klu) and Lutrol F68 (Lut), polymeric carriers, to improve solubility and bioavailability of LUMF following oral administration."( Lumefantrine solid dispersions with piperine for the enhancement of solubility, bioavailability and anti-parasite activity.
Aji, A; Deshmukh, PR; Ghule, BV; Inamdar, NN; Jane, K; Khade, RR; Kotagale, NR; Pendharkar, VV; Takale, NR, 2022
)
2.42
" However, LMN's therapeutic efficacy is diminished due to its low bioavailability when dosed as a crystalline solid."( Formulation and Scale-Up of Fast-Dissolving Lumefantrine Nanoparticles for Oral Malaria Therapy.
Armstrong, M; Ma, L; Nagapudi, K; Panmai, S; Prud'homme, RK; Ristroph, K; Tian, C; Wang, L; Yang, J; Zhang, D, 2023
)
1.17

Dosage Studied

Artemether-lumefantrine is likely to be very effective in Mbarara provided that patients receive clear dosage explanations. The predictive model through simulation of lumefanrine exposure at different dosage regimen scenarios for patients on EFV-based ART, suggest that AL taken twice daily for five days using the current dose could improve lumefantine exposure and consequently malaria treatment outcomes.

ExcerptRelevanceReference
" Characterisation of these pharmacokinetic-pharmacodynamic relationships provided the basis for dosage optimisation, an approach that could be applied to other antimalarial drugs."( Clinical pharmacokinetics and pharmacodynamics and pharmacodynamics of artemether-lumefantrine.
Ezzet, F; van Vugt, M; White, NJ, 1999
)
0.53
" The high adherence to artemether-lumefantrine found in our study suggest that this drug is likely to be very effective in Mbarara provided that patients receive clear dosage explanations."( Adherence to a six-dose regimen of artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in Uganda.
Bajunirwe, F; Biraro, S; Checchi, F; Fogg, C; Guthmann, JP; Kiguli, J; Kyomugisha, A; Musabe, J; Namiiro, P; Piola, P, 2004
)
0.86
" Insufficient numbers of tablets and inadequate package inserts result in sub-optimal dosing and possible treatment failure."( Malaria treatment failures after artemisinin-based therapy in three expatriates: could improved manufacturer information help to decrease the risk of treatment failure?
Chappuis, F; Jackson, Y; Loutan, L; Taylor, W, 2006
)
0.33
" The aim of this study was to describe the dose-response relationship between coadministration of fat and relative lumefantrine bioavailability, in order to determine the minimum amount of fat necessary to optimize absorption."( How much fat is necessary to optimize lumefantrine oral bioavailability?
Annerberg, A; Ashley, EA; Brockman, A; Kham, A; Lindegårdh, N; Nosten, F; Singhasivanon, P; Stepniewska, K; White, NJ, 2007
)
0.82
"A dose-response relationship was demonstrated between the volume of soya milk administered and lumefantrine bioavailability."( How much fat is necessary to optimize lumefantrine oral bioavailability?
Annerberg, A; Ashley, EA; Brockman, A; Kham, A; Lindegårdh, N; Nosten, F; Singhasivanon, P; Stepniewska, K; White, NJ, 2007
)
0.83
" Mothers/guardians of children were asked about fever in the last 14 days and related treatment actions including the timing, drugs used, dosing and adherence supported by visual aids of commonly available drug products."( The use of artemether-lumefantrine by febrile children following national implementation of a revised drug policy in Kenya.
Ajanga, A; Amin, AA; Gitonga, CW; Kangwana, BB; Noor, AM; Snow, RW, 2008
)
0.66
" However, AL has several limitations, including a twice-daily dosing regimen, recommendation for administration with fatty food, and a high risk of reinfection soon after therapy in high transmission areas."( Artemether-lumefantrine versus dihydroartemisinin-piperaquine for treating uncomplicated malaria: a randomized trial to guide policy in Uganda.
Bukirwa, H; Dorsey, G; Kamya, MR; Lugemwa, M; Rosenthal, PJ; Rwakimari, JB; Staedke, SG; Talisuna, A; Wabwire-Mangen, F; Yeka, A, 2008
)
0.74
"DP is highly efficacious, and operationally preferable to AL because of a less intensive dosing schedule and requirements."( Artemether-lumefantrine versus dihydroartemisinin-piperaquine for treating uncomplicated malaria: a randomized trial to guide policy in Uganda.
Bukirwa, H; Dorsey, G; Kamya, MR; Lugemwa, M; Rosenthal, PJ; Rwakimari, JB; Staedke, SG; Talisuna, A; Wabwire-Mangen, F; Yeka, A, 2008
)
0.74
" The greatest effort in the home management of malaria strategy should be in reducing delay in treatment and improving dosage and duration of treatment."( Community effectiveness of artemisinin-based combination therapy for malaria in rural southwestern Nigeria.
Ajayi, IO; Falade, CO; Gbotosho, GO; Happi, TC; Pagnoni, F; Yusuf, OB,
)
0.13
" Pharmacokinetic (PK) data informing the optimum dosing of these drug regimens is limited, especially in children."( Pharmacokinetics of artemether-lumefantrine and artesunate-amodiaquine in children in Kampala, Uganda.
Annerberg, A; Aweeka, F; Clark, TD; Dorsey, G; Drysdale, T; German, P; Kalyango, JN; Kamya, MR; Lindegardh, N; McGee, B; Mwesigwa, J; Parikh, S; Rosenthal, PJ, 2010
)
0.65
" falciparum malaria in central Sudan, although treatment with DHA-P (which requires a simpler dosing regimen) might be preferred to treatment with AL."( Dihydroartemisinin-piperaquine versus artemether-lumefantrine, in the treatment of uncomplicated Plasmodium falciparum malaria in central Sudan.
Adam, I; Elhassan, AH; Elmardi, KA; Eltahir, HG; Malik, EM; Salah, MT, 2010
)
0.62
" Patients were randomized to 3 different dosing groups (weights of 5 to <15 kg, 15 and <25 kg, and 25 to <35 kg)."( Pharmacokinetic and pharmacodynamic characteristics of a new pediatric formulation of artemether-lumefantrine in African children with uncomplicated Plasmodium falciparum malaria.
Abdulla, S; Bassat, Q; Borrmann, S; Djimdé, AA; Lefèvre, G; Lyimo, J; Mandomando, I; Tekete, M, 2011
)
0.59
" Simultaneously, the feared development of parasite drug resistance might drive dosing increases."( The pharmacogenetics of antimalaria artemisinin combination therapy.
Gil, JP; Piedade, R, 2011
)
0.37
" In the three AL body weight dosing groups (5 to < 15 kg, 15 to < 25 kg and 25 to < 35 kg), 80% of patients were aged 10-50 months, 46-100 months and 90-147 months, respectively."( Similar efficacy and safety of artemether-lumefantrine (Coartem®) in African infants and children with uncomplicated falciparum malaria across different body weight ranges.
Bashraheil, M; Bassat, Q; González, R; Kipkeu, C; Lefèvre, G; Lyimo, J; Machevo, S; Maiga, H; Mårtensson, A; Menéndez, C; Nahum, A; Nwaiwu, O; Ogutu, B; Ouma, P; Ubben, D; Walter, V, 2011
)
0.63
"Efficacy of AL in uncomplicated falciparum malaria is similar across body weight dosing groups as currently recommended in the label with no clinically relevant differences in safety or tolerability."( Similar efficacy and safety of artemether-lumefantrine (Coartem®) in African infants and children with uncomplicated falciparum malaria across different body weight ranges.
Bashraheil, M; Bassat, Q; González, R; Kipkeu, C; Lefèvre, G; Lyimo, J; Machevo, S; Maiga, H; Mårtensson, A; Menéndez, C; Nahum, A; Nwaiwu, O; Ogutu, B; Ouma, P; Ubben, D; Walter, V, 2011
)
0.63
" Many controversies were identified, including pharmacokinetic equivalence of novel dosage forms, altered pharmacokinetic parameters in children versus adults, effect of drug interactions, and association of pharmacokinetic changes with clinical outcomes."( Pharmacokinetic profile of artemisinin derivatives and companion drugs used in artemisinin-based combination therapies for the treatment of Plasmodium falciparum malaria in children.
Ensom, MH; Pawluk, SA; Wilby, KJ, 2013
)
0.39
"In the first study, the toxicity of artemether was evaluated in juvenile rats dosed with 0, 10, 30, and 100mg/kg/day on postpartum days (ppds) 7 to 21."( Neurotoxicity assessment of artemether in juvenile rats.
Beckman, DA; Butt, MT; Youreneff, M, 2013
)
0.39
" More studies with appropriate control groups in larger series are needed to characterize the degree to which pregnant women are underdosed with current antimalarial dosing regimens."( Pharmacokinetic properties of artemether, dihydroartemisinin, lumefantrine, and quinine in pregnant women with uncomplicated plasmodium falciparum malaria in Uganda.
Dhorda, M; Guerin, PJ; Jullien, V; Kloprogge, F; Nosten, F; Piola, P; Tarning, J; White, NJ, 2013
)
0.63
" Optimal lumefantrine dosage regimen for patients on EFV-based ART was determined by population pharmacokinetics and simulation."( The influence of nevirapine and efavirenz-based anti-retroviral therapy on the pharmacokinetics of lumefantrine and anti-malarial dose recommendation in HIV-malaria co-treatment.
Aklillu, E; Kamuhabwa, AA; Maganda, BA; Minzi, OM; Ngaimisi, E, 2015
)
1.05
" The predictive model through simulation of lumefantrine exposure at different dosage regimen scenarios for patients on EFV-based ART, suggest that AL taken twice daily for five days using the current dose could improve lumefantrine exposure and consequently malaria treatment outcomes."( The influence of nevirapine and efavirenz-based anti-retroviral therapy on the pharmacokinetics of lumefantrine and anti-malarial dose recommendation in HIV-malaria co-treatment.
Aklillu, E; Kamuhabwa, AA; Maganda, BA; Minzi, OM; Ngaimisi, E, 2015
)
0.89
"Specially created pediatric formulations have the potential to improve the acceptability, effectiveness, and accuracy of dosing of artemisinin-based combination therapy (ACT) in young children, a patient group that is inherently vulnerable to malaria."( Tailoring a Pediatric Formulation of Artemether-Lumefantrine for Treatment of Plasmodium falciparum Malaria.
Bassat, Q; Djimde, A; Hamed, K; Ogutu, B; Stricker, K, 2015
)
0.67
"Current artemether-lumefantrine dosing recommendations achieve day 7 lumefantrine concentrations ≥200 ng/ml and high cure rates in most uncomplicated malaria patients."( Artemether-lumefantrine treatment of uncomplicated Plasmodium falciparum malaria: a systematic review and meta-analysis of day 7 lumefantrine concentrations and therapeutic response using individual patient data.
, 2015
)
1.14
" The safety profiles of artesunate-mefloquine and artemether-lumefantrine were similar, with low rates of early vomiting (71 [15·3%] of 463 patients in the artesunate-mefloquine group vs 79 [16·8%] of 471 patients in the artemether-lumefantrine group in any of the three dosing days), few neurological adverse events (ten [2·1%] of 468 vs five [1·1%] of 465), and no detectable psychiatric adverse events."( Comparison of artesunate-mefloquine and artemether-lumefantrine fixed-dose combinations for treatment of uncomplicated Plasmodium falciparum malaria in children younger than 5 years in sub-Saharan Africa: a randomised, multicentre, phase 4 trial.
Ackermann, I; Aubin, F; Carn, G; Gesase, S; Lusingu, JPA; Mnkande, E; Mrango, Z; Mtoro, A; Ngocho, JS; Ogutu, B; Onyango, KO; Ouedraogo, A; Sirima, SB; Strub, N; Vanraes, J; Yaro, JB, 2016
)
0.93
" Further refinement of artemether-lumefantrine dosing to improve exposure in infants and very young children may be warranted."( Population Pharmacokinetics and Pharmacodynamics of Lumefantrine in Young Ugandan Children Treated With Artemether-Lumefantrine for Uncomplicated Malaria.
Arinaitwe, E; Aweeka, FT; Bergqvist, Y; Bigira, V; Blessborn, D; Creek, DJ; Kakuru, A; McCormack, SA; Muhindo, M; Parikh, S; Sambol, NC; Sukumar, N; Tappero, JW; Tchaparian, E; Wanzira, H, 2016
)
0.96
" However, the reduction in artemisinin exposure may warrant further study, and suggests that dosage adjustment of artemether-lumefantrine with nevirapine-based ART in children is likely warranted."( Concomitant nevirapine impacts pharmacokinetic exposure to the antimalarial artemether-lumefantrine in African children.
Aweeka, FT; Barlow-Mosha, L; Carey, V; Gingrich, D; Graham, B; Huang, L; Kamthunzi, P; Lindsey, JC; Marzan, F; Nachman, S; Parikh, S; Ssemambo, PK, 2017
)
0.88
" The available data suggest that ganaplacide exerts multi-stage antimalarial activity, and that its pharmacokinetic profile potentially allows for a simplified dosing regimen compared to that of existing antimalarial drug combinations."( The  early  preclinical and clinical development of ganaplacide (KAF156), a novel antimalarial compound.
Grobusch, MP; Koller, R; Mombo-Ngoma, G, 2018
)
0.48
" Coupling nanoparticle production using FNP processing with spray drying offers a continuous nanofabrication platform to scale up nanoparticle synthesis and processing into solid dosage forms."( Translational formulation of nanoparticle therapeutics from laboratory discovery to clinical scale.
Armstrong, M; Feng, J; Markwalter, CE; Prud'homme, RK; Tian, C, 2019
)
0.51
" These data suggest that malaria and HIV coinfected pregnant women may require adjustments in AL dosage or treatment duration to achieve exposure comparable with HIV-uninfected pregnant women."( Efavirenz-Based Antiretroviral Therapy Reduces Artemether-Lumefantrine Exposure for Malaria Treatment in HIV-Infected Pregnant Women.
Aweeka, F; Huang, L; Hughes, E; Kajubi, R; Mwebaza, N; Mwima, MW; Nguyen, V; Nyunt, MM; Orukan, F; Parikh, S, 2020
)
0.8
"Good powder flow is critical for powders destined for inclusion into tablets - especially when employing direct compression as method of manufacture - in this case, lipid matrix tablets, which have demonstrated huge promise as a prospective dosage form for future use in malarial treatment."( Characterization of solid lipid dispersions prepared by hot fusion containing a double-fixed dose combination of artemether and lumefantrine.
du Plessis, LH; Viljoen, JM; Wilkins, CA, 2020
)
0.76
" Dosing is suboptimal in young children."( The Impact of Extended Treatment With Artemether-lumefantrine on Antimalarial Exposure and Reinfection Risks in Ugandan Children With Uncomplicated Malaria: A Randomized Controlled Trial.
Aweeka, FT; Colt, M; Goodwin, J; Huang, L; Kajubi, R; Li, F; Mwebaza, N; Orukan, F; Parikh, S; Richards, K; Wang, K; Whalen, ME, 2023
)
1.16
" Participants were randomly allocated 1:1 to antimalarial chemoprophylaxis, a 3-day course of twice-daily artemether-lumefantrine followed by the same daily dosing once a week while travelling in the forest and for a further 4 weeks after leaving the forest (four tablets per dose; 20 mg of artemether and 120 mg of lumefantrine per tablet), or a multivitamin with no antimalarial activity."( Antimalarial chemoprophylaxis for forest goers in southeast Asia: an open-label, individually randomised controlled trial.
Callery, JJ; Chotthanawathit, P; Conradis-Jansen, F; Dondorp, AM; Duanguppama, J; Ean, M; Heng, C; Imwong, M; Jongdeepaisal, M; Khonputsa, P; Madmanee, W; Maude, RJ; Mukaka, M; Peerawaranun, P; Pell, C; Peto, TJ; Pongsoipetch, K; Rekol, H; Sokha, M; Sovannaroth, S; Soviet, U; Tarning, J; Tripura, R; von Seidlein, L; Waithira, N; White, NJ, 2023
)
1.12
" However, LMN's therapeutic efficacy is diminished due to its low bioavailability when dosed as a crystalline solid."( Formulation and Scale-Up of Fast-Dissolving Lumefantrine Nanoparticles for Oral Malaria Therapy.
Armstrong, M; Ma, L; Nagapudi, K; Panmai, S; Prud'homme, RK; Ristroph, K; Tian, C; Wang, L; Yang, J; Zhang, D, 2023
)
1.17
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (1)

RoleDescription
antimalarialA drug used in the treatment of malaria. Antimalarials are usually classified on the basis of their action against Plasmodia at different stages in their life cycle in the human.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (4)

ClassDescription
tertiary amineA compound formally derived from ammonia by replacing three hydrogen atoms by hydrocarbyl groups.
monochlorobenzenesAny member of the class of chlorobenzenes containing a mono- or poly-substituted benzene ring in which only one substituent is chlorine.
secondary alcoholA secondary alcohol is a compound in which a hydroxy group, -OH, is attached to a saturated carbon atom which has two other carbon atoms attached to it.
fluorenesAn ortho-fused polycyclic arene in which the skeleton is composed of two benzene rings ortho-fused to cyclopentane.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (38)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
acetylcholinesteraseHomo sapiens (human)Potency34.67130.002541.796015,848.9004AID1347398
phosphopantetheinyl transferaseBacillus subtilisPotency84.39270.141337.9142100.0000AID1490; AID2701; AID2707
RAR-related orphan receptor gammaMus musculus (house mouse)Potency29.84930.006038.004119,952.5996AID1159521; AID1159523
SMAD family member 2Homo sapiens (human)Potency23.91450.173734.304761.8120AID1346859
SMAD family member 3Homo sapiens (human)Potency23.91450.173734.304761.8120AID1346859
GLI family zinc finger 3Homo sapiens (human)Potency13.48880.000714.592883.7951AID1259369; AID1259392
AR proteinHomo sapiens (human)Potency8.48520.000221.22318,912.5098AID743035
caspase 7, apoptosis-related cysteine proteaseHomo sapiens (human)Potency33.49150.013326.981070.7614AID1346978
nuclear receptor subfamily 1, group I, member 3Homo sapiens (human)Potency25.28400.001022.650876.6163AID1224838; AID1224839; AID1224893
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency26.82430.01237.983543.2770AID1346984; AID1645841
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency26.83250.000214.376460.0339AID720691; AID720692
retinoic acid nuclear receptor alpha variant 1Homo sapiens (human)Potency13.71430.003041.611522,387.1992AID1159552; AID1159555
retinoid X nuclear receptor alphaHomo sapiens (human)Potency26.83250.000817.505159.3239AID1159527
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency33.81910.001530.607315,848.9004AID1224848; AID1224849; AID1259403
pregnane X nuclear receptorHomo sapiens (human)Potency10.32970.005428.02631,258.9301AID1346982; AID1346985
estrogen nuclear receptor alphaHomo sapiens (human)Potency23.71010.000229.305416,493.5996AID743079
GVesicular stomatitis virusPotency21.87610.01238.964839.8107AID1645842
cytochrome P450 2D6Homo sapiens (human)Potency0.34670.00108.379861.1304AID1645840
caspase-3Homo sapiens (human)Potency33.49150.013326.981070.7614AID1346978
aryl hydrocarbon receptorHomo sapiens (human)Potency25.15670.000723.06741,258.9301AID743085; AID743122
nuclear factor of kappa light polypeptide gene enhancer in B-cells 1 (p105), isoform CRA_aHomo sapiens (human)Potency2.683219.739145.978464.9432AID1159509
v-jun sarcoma virus 17 oncogene homolog (avian)Homo sapiens (human)Potency22.61420.057821.109761.2679AID1159526; AID1159528
nuclear receptor subfamily 1, group I, member 2Rattus norvegicus (Norway rat)Potency25.11890.10009.191631.6228AID1346983
Histone H2A.xCricetulus griseus (Chinese hamster)Potency61.93150.039147.5451146.8240AID1224845; AID1224896
Caspase-7Cricetulus griseus (Chinese hamster)Potency33.49150.006723.496068.5896AID1346980
potassium voltage-gated channel subfamily H member 2 isoform dHomo sapiens (human)Potency12.58930.01789.637444.6684AID588834
caspase-3Cricetulus griseus (Chinese hamster)Potency33.49150.006723.496068.5896AID1346980
thyroid hormone receptor beta isoform 2Rattus norvegicus (Norway rat)Potency29.84930.000323.4451159.6830AID743065; AID743067
heat shock protein beta-1Homo sapiens (human)Potency33.48890.042027.378961.6448AID743210
nuclear receptor ROR-gamma isoform 1Mus musculus (house mouse)Potency19.95260.00798.23321,122.0200AID2546
gemininHomo sapiens (human)Potency23.71500.004611.374133.4983AID624297
peripheral myelin protein 22Rattus norvegicus (Norway rat)Potency32.19680.005612.367736.1254AID624032
Interferon betaHomo sapiens (human)Potency21.87610.00339.158239.8107AID1645842
HLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)Potency21.87610.01238.964839.8107AID1645842
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency39.81070.009610.525035.4813AID1479145
Inositol hexakisphosphate kinase 1Homo sapiens (human)Potency21.87610.01238.964839.8107AID1645842
cytochrome P450 2C9, partialHomo sapiens (human)Potency21.87610.01238.964839.8107AID1645842
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Potassium voltage-gated channel subfamily H member 2Homo sapiens (human)IC50 (µMol)5.53510.00091.901410.0000AID1445968; AID240820; AID576612
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (67)

Processvia Protein(s)Taxonomy
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
positive regulation of T cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
adaptive immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class I via ER pathway, TAP-independentHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of T cell anergyHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
defense responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
detection of bacteriumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-12 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-6 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protection from natural killer cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
innate immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of dendritic cell differentiationHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class IbHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of heart rate by cardiac conductionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of heart rate by hormonePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of membrane potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
positive regulation of DNA-templated transcriptionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion homeostasisPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
cardiac muscle contractionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of membrane repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of ventricular cardiac muscle cell membrane repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
cellular response to xenobiotic stimulusPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
ventricular cardiac muscle cell action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane depolarization during action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarization during action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarization during cardiac muscle cell action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of heart rate by cardiac conductionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion export across plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarization during ventricular cardiac muscle cell action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
negative regulation of potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
positive regulation of potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
negative regulation of potassium ion export across plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion import across plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
inositol phosphate metabolic processInositol hexakisphosphate kinase 1Homo sapiens (human)
phosphatidylinositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
negative regulation of cold-induced thermogenesisInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (29)

Processvia Protein(s)Taxonomy
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
signaling receptor bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
peptide antigen bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein-folding chaperone bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
transcription cis-regulatory region bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
inward rectifier potassium channel activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
delayed rectifier potassium channel activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
protein bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
ubiquitin protein ligase bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
identical protein bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
protein homodimerization activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
C3HC4-type RING finger domain bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel activity involved in cardiac muscle cell action potential repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
scaffold protein bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel activity involved in ventricular cardiac muscle cell action potential repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
inositol-1,3,4,5,6-pentakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol heptakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
ATP bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 1-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 3-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol 5-diphosphate pentakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol diphosphate tetrakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (26)

Processvia Protein(s)Taxonomy
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
Golgi membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
endoplasmic reticulumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
Golgi apparatusHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
cell surfaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
ER to Golgi transport vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
secretory granule membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
phagocytic vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
early endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
recycling endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular exosomeHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
lumenal side of endoplasmic reticulum membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
MHC class I protein complexHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular spaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
external side of plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
cell surfacePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
perinuclear region of cytoplasmPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel complexPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
inward rectifier potassium channel complexPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
fibrillar centerInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
cytosolInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleusInositol hexakisphosphate kinase 1Homo sapiens (human)
cytoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (149)

Assay IDTitleYearJournalArticle
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID558832Antimalarial activity against Plasmodium falciparum HB3 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID497995AUC (0-infinity) in Ugandan children patient with uncomplicated malaria administered twice daily for 3 days as 20/120 mg tablets containing artemether-lumefantrine combination2010Antimicrobial agents and chemotherapy, Jan, Volume: 54, Issue:1
Pharmacokinetics of artemether-lumefantrine and artesunate-amodiaquine in children in Kampala, Uganda.
AID582696Cmax in pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 5 days coadministered with 20 mg artemether by two-compartment population pharmacokinetic model2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID562112Selectivity ratio of IC50 for Plasmodium falciparum 3D7 to IC50 for multidrug-resistant Plasmodium falciparum VS/12009Antimicrobial agents and chemotherapy, Jul, Volume: 53, Issue:7
In vitro chemosensitization of Plasmodium falciparum to antimalarials by verapamil and probenecid.
AID558836Antimalarial activity against Plasmodium falciparum IMT A4 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID564240Antiplasmodial activity against Plasmodium falciparum harboring mutant pfcrt-76 and wild type pfmdr-1-86 gene after 18 hrs by [3H]hypoxanthine incorporation assay2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
In vitro activities of piperaquine, lumefantrine, and dihydroartemisinin in Kenyan Plasmodium falciparum isolates and polymorphisms in pfcrt and pfmdr1.
AID564242Antiplasmodial activity against Plasmodium falciparum harboring wild type pfcrt-76 and wild type pfmdr-1-86 gene after 18 hrs by [3H]hypoxanthine incorporation assay2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
In vitro activities of piperaquine, lumefantrine, and dihydroartemisinin in Kenyan Plasmodium falciparum isolates and polymorphisms in pfcrt and pfmdr1.
AID558837Antimalarial activity against Plasmodium falciparum IMT 31 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID1168868Antimalarial activity against chloroquine-sensitive Plasmodium falciparum 3D7 infected in human type A-positive red blood cells assessed as growth inhibition after 72 hrs by spectrophotometrically2014Bioorganic & medicinal chemistry, Nov-01, Volume: 22, Issue:21
Synthesis and evaluation of the antiplasmodial activity of novel indeno[2,1-c]quinoline derivatives.
AID582702Drug concentration in pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 3 days coadministered with 20 mg artemether measured after 7 days by two-compartment populati2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID1168869Antimalarial activity against chloroquine-resistant Plasmodium falciparum W2 infected in human type A-positive red blood cells assessed as growth inhibition after 72 hrs by spectrophotometrically2014Bioorganic & medicinal chemistry, Nov-01, Volume: 22, Issue:21
Synthesis and evaluation of the antiplasmodial activity of novel indeno[2,1-c]quinoline derivatives.
AID558841Antimalarial activity against Plasmodium falciparum IMT 10500 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID582709Apparent volume of distribution in pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 3 days coadministered with 20 mg artemether by two-compartment population pharma2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID582700Drug concentration in pregnant human with uncomplicated multidrug-resistant Plasmodium falciparum malaria infection at 120 mg, po administered as 4 tablets BID for 3 days coadministered with 20 mg artemether2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID240820Inhibitory concentration against IKr potassium channel2004Bioorganic & medicinal chemistry letters, Sep-20, Volume: 14, Issue:18
The pharmacophore hypotheses of I(Kr) potassium channel blockers: novel class III antiarrhythmic agents.
AID564239Antiplasmodial activity against Plasmodium falciparum harboring mutant pfcrt-76 and mutant pfmdr-1-86 gene after 18 hrs by [3H]hypoxanthine incorporation assay2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
In vitro activities of piperaquine, lumefantrine, and dihydroartemisinin in Kenyan Plasmodium falciparum isolates and polymorphisms in pfcrt and pfmdr1.
AID1593291Antimalarial activity against drug-resistant Plasmodium falciparum 3D7 harboring A82T/V259L double mutant infected in human erythrocytes after 72 hrs by SYBR green 1-based fluorescence assay2019Journal of medicinal chemistry, 04-11, Volume: 62, Issue:7
Discovery and Structural Optimization of Acridones as Broad-Spectrum Antimalarials.
AID582704Terminal elimination half-life in pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 3 days coadministered with 20 mg artemether by two-compartment population pharmac2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID497987Half life in Ugandan children patient with uncomplicated malaria administered twice daily for 3 days as 20/120 mg tablets containing artemether-lumefantrine combination2010Antimicrobial agents and chemotherapy, Jan, Volume: 54, Issue:1
Pharmacokinetics of artemether-lumefantrine and artesunate-amodiaquine in children in Kampala, Uganda.
AID564232Antiplasmodial activity against Plasmodium falciparum clinical isolate after 18 hrs by [3H]hypoxanthine incorporation assay2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
In vitro activities of piperaquine, lumefantrine, and dihydroartemisinin in Kenyan Plasmodium falciparum isolates and polymorphisms in pfcrt and pfmdr1.
AID519195Antimicrobial activity against Plasmodium vivax trophozoites measured after 30 hrs by microscopy2008Antimicrobial agents and chemotherapy, Mar, Volume: 52, Issue:3
Determinants of in vitro drug susceptibility testing of Plasmodium vivax.
AID558844Antimalarial activity against Plasmodium falciparum IMT K2 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID582694Cmax in pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 5 days coadministered with 20 mg artemether measured after 7 days by two-compartment population pharmacokin2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID558840Antimalarial activity against Plasmodium falciparum IMT 10336 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID562110Antiplasmodial activity against multidrug-resistant Plasmodium falciparum VS/1 by [3H]hypoxanthine incorporation assay2009Antimicrobial agents and chemotherapy, Jul, Volume: 53, Issue:7
In vitro chemosensitization of Plasmodium falciparum to antimalarials by verapamil and probenecid.
AID558834Antimalarial activity against Plasmodium falciparum IMT Bres assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID582697Cmax in pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 4 days coadministered with 20 mg artemether by two-compartment population pharmacokinetic model2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID643459Antimalarial activity against Plasmodium berghei ANKA infected in C57BL/6 mouse assessed as decrease in parasitemia at 18 mg/kg, po administered 24 hrs post-infection measured after 3 days by Giemsa microscopy relative to vehicle treated control2012Journal of medicinal chemistry, Jan-12, Volume: 55, Issue:1
Malaria-infected mice are completely cured by one 6 mg/kg oral dose of a new monomeric trioxane sulfide combined with mefloquine.
AID519197Antimicrobial activity against Plasmodium vivax trophozoites measured within 30 hrs by microscopy2008Antimicrobial agents and chemotherapy, Mar, Volume: 52, Issue:3
Determinants of in vitro drug susceptibility testing of Plasmodium vivax.
AID529905Antiplasmodial activity against Plasmodium falciparum harboring K1 allele group of msp1, 3D7 allele group of msp2 gene and 94 bp of 7A11, 196bp of C4M79 and 336bp of C4M69 locus measured on day 23 by [3H]hypoxanthine incorporation assay2008Antimicrobial agents and chemotherapy, Jun, Volume: 52, Issue:6
First case of emergence of atovaquone-proguanil resistance in Plasmodium falciparum during treatment in a traveler in Comoros.
AID558829Antimalarial activity against Plasmodium falciparum FCM29 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID1593290Antimalarial activity against Plasmodium falciparum 3D7 infected in human erythrocytes after 72 hrs by SYBR green 1-based fluorescence assay2019Journal of medicinal chemistry, 04-11, Volume: 62, Issue:7
Discovery and Structural Optimization of Acridones as Broad-Spectrum Antimalarials.
AID519196Antimicrobial activity against Plasmodium vivax at the ring stage measured after 30 hrs by microscopy2008Antimicrobial agents and chemotherapy, Mar, Volume: 52, Issue:3
Determinants of in vitro drug susceptibility testing of Plasmodium vivax.
AID449703NOVARTIS: Inhibition of Plasmodium falciparum 3D7 (drug-susceptible) proliferation in erythrocyte-based infection assay 2008Proceedings of the National Academy of Sciences of the United States of America, Jul-01, Volume: 105, Issue:26
In silico activity profiling reveals the mechanism of action of antimalarials discovered in a high-throughput screen.
AID547315Antimalarial activity against Plasmodium falciparum2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
In vitro activities of quinine and other antimalarials and pfnhe polymorphisms in Plasmodium isolates from Kenya.
AID582706Absorption rate constant in pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 3 days coadministered with 20 mg artemether by two-compartment population pharmacokinet2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID1593253Antimalarial activity against multidrug-resistant Plasmodium falciparum Dd2 infected in human erythrocytes by SYBR green 1-based fluorescence assay2019Journal of medicinal chemistry, 04-11, Volume: 62, Issue:7
Discovery and Structural Optimization of Acridones as Broad-Spectrum Antimalarials.
AID511252Antimicrobial activity against chloroquine-sensitive Plasmodium falciparum W2 by ELISA2010Antimicrobial agents and chemotherapy, Mar, Volume: 54, Issue:3
In vitro sensitivities of Plasmodium falciparum to different antimalarial drugs in Uganda.
AID582705Volume of distribution at steady state in pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 3 days coadministered with 20 mg artemether by two-compartment population2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID558830Antimalarial activity against Plasmodium falciparum FCR3 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID511251Antimicrobial activity against Plasmodium falciparum by ELISA2010Antimicrobial agents and chemotherapy, Mar, Volume: 54, Issue:3
In vitro sensitivities of Plasmodium falciparum to different antimalarial drugs in Uganda.
AID582698Cmax in pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 3 days coadministered with 20 mg artemether by two-compartment population pharmacokinetic model2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID564235Antiplasmodial activity against Plasmodium falciparum harboring mutant pfcrt-76 gene after 18 hrs by [3H]hypoxanthine incorporation assay2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
In vitro activities of piperaquine, lumefantrine, and dihydroartemisinin in Kenyan Plasmodium falciparum isolates and polymorphisms in pfcrt and pfmdr1.
AID564238Antiplasmodial activity against Plasmodium falciparum harboring wild type and mutant pfmdr-1-86 gene after 18 hrs by [3H]hypoxanthine incorporation assay2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
In vitro activities of piperaquine, lumefantrine, and dihydroartemisinin in Kenyan Plasmodium falciparum isolates and polymorphisms in pfcrt and pfmdr1.
AID158865Antimalarial activity against Plasmodium falciparum Dd2 in erythrocytes2002Bioorganic & medicinal chemistry letters, Feb-25, Volume: 12, Issue:4
Structure-activity relationships of novel anti-malarial agents. Part 3: N-(4-acylamino-3-benzoylphenyl)-4-propoxycinnamic acid amides.
AID558838Antimalarial activity against Plasmodium falciparum IMT 8425 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID449705NOVARTIS: Cytotoxicity against human hepatocellular carcinoma cell line (Huh7)2008Proceedings of the National Academy of Sciences of the United States of America, Jul-01, Volume: 105, Issue:26
In silico activity profiling reveals the mechanism of action of antimalarials discovered in a high-throughput screen.
AID643456Antimalarial activity against Plasmodium berghei ANKA infected in C57BL/6 mouse assessed as host survival at 18 mg/kg, po administered 24 hrs post-infection (Rvb = 6.8 days)2012Journal of medicinal chemistry, Jan-12, Volume: 55, Issue:1
Malaria-infected mice are completely cured by one 6 mg/kg oral dose of a new monomeric trioxane sulfide combined with mefloquine.
AID1688324Antimalarial activity against Plasmodium falciparum 3D7A asexual forms assessed as inhibition of [G-3H]hypoxanthine uptake incubated for 24 hrs followed by [G-3H]hypoxanthine addition and measured after 18 hrs by liquid scintillation spectrometry2020European journal of medicinal chemistry, Feb-15, Volume: 188Current progress in antimalarial pharmacotherapy and multi-target drug discovery.
AID511255Antimicrobial activity against chloroquine-resistant Plasmodium falciparum K1 by ELISA2010Antimicrobial agents and chemotherapy, Mar, Volume: 54, Issue:3
In vitro sensitivities of Plasmodium falciparum to different antimalarial drugs in Uganda.
AID576612Inhibition of human ERG2011European journal of medicinal chemistry, Feb, Volume: 46, Issue:2
Predicting hERG activities of compounds from their 3D structures: development and evaluation of a global descriptors based QSAR model.
AID582710Clearance in pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 3 days coadministered with 20 mg artemether by two-compartment population pharmacokinetic model2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID582701Drug concentration in pregnant human patient with reappeared uncomplicated multidrug-resistant Plasmodium falciparum malaria infection at 120 mg, po administered as 4 tablets BID for 3 days coadministered with 20 mg artemether2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID635308Antimalarial activity against chloroquine-resistant Plasmodium falciparum W2mef infected in human erythrocytes assessed as inhibition of [3H]hypoxanthine incorporation after 48 hrs by beta liquid scintillation counting method2011Bioorganic & medicinal chemistry, Dec-15, Volume: 19, Issue:24
Synthesis and antimalarial evaluation of novel isocryptolepine derivatives.
AID558835Antimalarial activity against Plasmodium falciparum IMT Guy assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID558827Antimalarial activity against Plasmodium falciparum W2 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID558847Antimalarial activity against Plasmodium falciparum IMT Vol assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID582708Intercompartmental clearance in pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 3 days coadministered with 20 mg artemether by two-compartment population pharmacok2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID582703AUC (0 to infinity) in pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 3 days coadministered with 20 mg artemether by two-compartment population pharmacokinetic mo2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID1593288Antimalarial activity against drug-resistant Plasmodium falciparum Dd2 harboring M133I/A138T double mutant infected in human erythrocytes after 72 hrs by SYBR green 1-based fluorescence assay2019Journal of medicinal chemistry, 04-11, Volume: 62, Issue:7
Discovery and Structural Optimization of Acridones as Broad-Spectrum Antimalarials.
AID564230Antiplasmodial activity against multidrug-resistant Plasmodium falciparum VS/1 after 18 hrs by [3H]hypoxanthine incorporation assay2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
In vitro activities of piperaquine, lumefantrine, and dihydroartemisinin in Kenyan Plasmodium falciparum isolates and polymorphisms in pfcrt and pfmdr1.
AID1168867Antimalarial activity against chloroquine-sensitive Plasmodium falciparum D10 infected in human type A-positive red blood cells assessed as growth inhibition after 72 hrs by spectrophotometrically2014Bioorganic & medicinal chemistry, Nov-01, Volume: 22, Issue:21
Synthesis and evaluation of the antiplasmodial activity of novel indeno[2,1-c]quinoline derivatives.
AID748941Terminal half life in human2013Bioorganic & medicinal chemistry letters, May-15, Volume: 23, Issue:10
Recent advances in malaria drug discovery.
AID582695Cmax in pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 4 days coadministered with 20 mg artemether measured after 7 days by two-compartment population pharmacokin2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID564234Antiplasmodial activity against Plasmodium falciparum harboring wild type and mutant pfcrt-76 gene after 18 hrs by [3H]hypoxanthine incorporation assay2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
In vitro activities of piperaquine, lumefantrine, and dihydroartemisinin in Kenyan Plasmodium falciparum isolates and polymorphisms in pfcrt and pfmdr1.
AID564237Antiplasmodial activity against Plasmodium falciparum harboring mutant pfmdr-1-86 gene after 18 hrs by [3H]hypoxanthine incorporation assay2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
In vitro activities of piperaquine, lumefantrine, and dihydroartemisinin in Kenyan Plasmodium falciparum isolates and polymorphisms in pfcrt and pfmdr1.
AID558843Antimalarial activity against Plasmodium falciparum IMT K14 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID564241Antiplasmodial activity against Plasmodium falciparum harboring wild type pfcrt-76 and mutant pfmdr-1-86 gene after 18 hrs by [3H]hypoxanthine incorporation assay2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
In vitro activities of piperaquine, lumefantrine, and dihydroartemisinin in Kenyan Plasmodium falciparum isolates and polymorphisms in pfcrt and pfmdr1.
AID158864Antimalarial activity against Plasmodium falciparum 3D7 in erythrocytes2002Bioorganic & medicinal chemistry letters, Feb-25, Volume: 12, Issue:4
Structure-activity relationships of novel anti-malarial agents. Part 3: N-(4-acylamino-3-benzoylphenyl)-4-propoxycinnamic acid amides.
AID497988Cmax in Ugandan children patient with uncomplicated malaria administered twice daily for 3 days as 20/120 mg tablets containing artemether-lumefantrine combination2010Antimicrobial agents and chemotherapy, Jan, Volume: 54, Issue:1
Pharmacokinetics of artemether-lumefantrine and artesunate-amodiaquine in children in Kampala, Uganda.
AID449706NOVARTIS: Inhibition Frequency Index (IFI) - the number of HTS assays where a compound showed > 50% inhibition/induction, expressed as a percentage of the number of assays in which the compound was tested.2008Proceedings of the National Academy of Sciences of the United States of America, Jul-01, Volume: 105, Issue:26
In silico activity profiling reveals the mechanism of action of antimalarials discovered in a high-throughput screen.
AID1445968Inhibition of human ERG by fluorescence polarization assay2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
3-Hydroxy-N'-arylidenepropanehydrazonamides with Halo-Substituted Phenanthrene Scaffolds Cure P. berghei Infected Mice When Administered Perorally.
AID519198Antimicrobial activity against Plasmodium vivax at the ring stage measured within 30 hrs by microscopy2008Antimicrobial agents and chemotherapy, Mar, Volume: 52, Issue:3
Determinants of in vitro drug susceptibility testing of Plasmodium vivax.
AID558845Antimalarial activity against Plasmodium falciparum IMT K4 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID564236Antiplasmodial activity against Plasmodium falciparum harboring wild type pfmdr-1-86 gene after 18 hrs by [3H]hypoxanthine incorporation assay2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
In vitro activities of piperaquine, lumefantrine, and dihydroartemisinin in Kenyan Plasmodium falciparum isolates and polymorphisms in pfcrt and pfmdr1.
AID1649432Antimalarial activity against Plasmodium falciparum clinical isolates measured after 72 hrs by SYBR green dye based fluorescence assay2020Journal of medicinal chemistry, 06-11, Volume: 63, Issue:11
Lead Optimization of Second-Generation Acridones as Broad-Spectrum Antimalarials.
AID449704NOVARTIS: Inhibition of Plasmodium falciparum W2 (drug-resistant) proliferation in erythrocyte-based infection assay2008Proceedings of the National Academy of Sciences of the United States of America, Jul-01, Volume: 105, Issue:26
In silico activity profiling reveals the mechanism of action of antimalarials discovered in a high-throughput screen.
AID582711Cmax in venous plasma of pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 5 days coadministered with 20 mg artemether measured on 7 days by two-compartment populati2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID511254Antimicrobial activity against chloroquine-resistant Plasmodium falciparum HB3 by ELISA2010Antimicrobial agents and chemotherapy, Mar, Volume: 54, Issue:3
In vitro sensitivities of Plasmodium falciparum to different antimalarial drugs in Uganda.
AID511253Antimicrobial activity against chloroquine-sensitive Plasmodium falciparum D6 by ELISA2010Antimicrobial agents and chemotherapy, Mar, Volume: 54, Issue:3
In vitro sensitivities of Plasmodium falciparum to different antimalarial drugs in Uganda.
AID558833Antimalarial activity against Plasmodium falciparum 106/1 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID558828Antimalarial activity against Plasmodium falciparum D6 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID558831Antimalarial activity against Plasmodium falciparum PA assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID564231Antiplasmodial activity against multidrug-sensitive Plasmodium falciparum 3D7 after 18 hrs by [3H]hypoxanthine incorporation assay2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
In vitro activities of piperaquine, lumefantrine, and dihydroartemisinin in Kenyan Plasmodium falciparum isolates and polymorphisms in pfcrt and pfmdr1.
AID1593289Antimalarial activity against drug-resistant Plasmodium falciparum Dd2 harboring M133I mutant infected in human erythrocytes after 72 hrs by SYBR green 1-based fluorescence assay2019Journal of medicinal chemistry, 04-11, Volume: 62, Issue:7
Discovery and Structural Optimization of Acridones as Broad-Spectrum Antimalarials.
AID562111Antiplasmodial activity against Plasmodium falciparum 3D7 by [3H]hypoxanthine incorporation assay2009Antimicrobial agents and chemotherapy, Jul, Volume: 53, Issue:7
In vitro chemosensitization of Plasmodium falciparum to antimalarials by verapamil and probenecid.
AID558842Antimalarial activity against Plasmodium falciparum IMT 16332 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID157697Anti-malarial activity against Plasmodium falciparum Dd22003Bioorganic & medicinal chemistry letters, Feb-10, Volume: 13, Issue:3
Structure-activity relationships of novel anti-malarial agents: part 5. N-(4-acylamino-3-benzoylphenyl)-[5-(4-nitrophenyl)-2-furyl]acrylic acid amides.
AID157697Anti-malarial activity against Plasmodium falciparum Dd22003Bioorganic & medicinal chemistry letters, May-05, Volume: 13, Issue:9
Structure-activity relationships of novel anti-malarial agents. Part 6: N-(4-arylpropionylamino-3-benzoylphenyl)-[5-(4-nitrophenyl)-2-furyl]acrylic acid amides.
AID1593287Antimalarial activity against drug-resistant Plasmodium falciparum Dd2 harboring V259L mutant infected in human erythrocytes after 72 hrs by SYBR green 1-based fluorescence assay2019Journal of medicinal chemistry, 04-11, Volume: 62, Issue:7
Discovery and Structural Optimization of Acridones as Broad-Spectrum Antimalarials.
AID497976AUC (0-120 hrs) in Ugandan children patient with uncomplicated malaria assessed as dihydroartemisin administered twice daily for 3 days as 20/120 mg tablets containing artemether-lumefantrine combination2010Antimicrobial agents and chemotherapy, Jan, Volume: 54, Issue:1
Pharmacokinetics of artemether-lumefantrine and artesunate-amodiaquine in children in Kampala, Uganda.
AID158715Inhibition against Plasmodium falciparum Dd2 in erythrocytes in semiautomated micro dilution assay2003Bioorganic & medicinal chemistry letters, Jul-07, Volume: 13, Issue:13
Structure-activity relationships of novel anti-malarial agents. Part 7: N-(3-benzoyl-4-tolylacetylaminophenyl)-3-(5-aryl-2-furyl)acrylic acid amides with polar moieties.
AID558826Antimalarial activity against Plasmodium falciparum 3D7 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID582707Apparent peripheral volume of distribution in pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 3 days coadministered with 20 mg artemether by two-compartment popula2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID748936Antiplasmodial activity against multidrug-resistant Plasmodium falciparum W2 infected in human erythrocytes2013Bioorganic & medicinal chemistry letters, May-15, Volume: 23, Issue:10
Recent advances in malaria drug discovery.
AID1593296Inhibition of Plasmodium falciparum cytochrome b-c12019Journal of medicinal chemistry, 04-11, Volume: 62, Issue:7
Discovery and Structural Optimization of Acridones as Broad-Spectrum Antimalarials.
AID158852Inhibitory activity against Plasmodium falciparum Dd2 in erythrocytes by semiautomated micro dilution2003Bioorganic & medicinal chemistry letters, Feb-10, Volume: 13, Issue:3
Structure-activity relationships of novel anti-malarial agents: part 5. N-(4-acylamino-3-benzoylphenyl)-[5-(4-nitrophenyl)-2-furyl]acrylic acid amides.
AID158852Inhibitory activity against Plasmodium falciparum Dd2 in erythrocytes by semiautomated micro dilution2003Bioorganic & medicinal chemistry letters, May-05, Volume: 13, Issue:9
Structure-activity relationships of novel anti-malarial agents. Part 6: N-(4-arylpropionylamino-3-benzoylphenyl)-[5-(4-nitrophenyl)-2-furyl]acrylic acid amides.
AID511256Antimicrobial activity against Plasmodium falciparum harboring mdr1 N86Y/D1246Y/Y184F mutant gene by ELISA2010Antimicrobial agents and chemotherapy, Mar, Volume: 54, Issue:3
In vitro sensitivities of Plasmodium falciparum to different antimalarial drugs in Uganda.
AID582712Tlag in pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 3 days coadministered with 20 mg artemether measured after 7 days by two-compartment population pharmacokin2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID582693Cmax in capillary plasma of pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 5 days coadministered with 20 mg artemether measured on 7 days by two-compartment popul2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID558839Antimalarial activity against Plasmodium falciparum IMT 9881 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID558846Antimalarial activity against Plasmodium falciparum IMT L1 assessed as incorporation of [3H]hypoxanthine after 48 hrs by scintillation counter2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Atorvastatin is a promising partner for antimalarial drugs in treatment of Plasmodium falciparum malaria.
AID582699Drug concentration in pregnant human patient with uncomplicated multidrug-resistant Plasmodium falciparum malaria at 120 mg, po administered as 4 tablets BID for 3 days coadministered with 20 mg artemether2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria.
AID555962Antimalarial activity against chloroquine-resistant Plasmodium vivax by Giemsa staining2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
In vivo and in vitro efficacy of amodiaquine monotherapy for treatment of infection by chloroquine-resistant Plasmodium vivax.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347057CD47-SIRPalpha protein protein interaction - LANCE assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347405qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS LOPAC collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347410qHTS for inhibitors of adenylyl cyclases using a fission yeast platform: a pilot screen against the NCATS LOPAC library2019Cellular signalling, 08, Volume: 60A fission yeast platform for heterologous expression of mammalian adenylyl cyclases and high throughput screening.
AID1347059CD47-SIRPalpha protein protein interaction - Alpha assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347151Optimization of GU AMC qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347058CD47-SIRPalpha protein protein interaction - HTRF assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1794808Fluorescence-based screening to identify small molecule inhibitors of Plasmodium falciparum apicoplast DNA polymerase (Pf-apPOL).2014Journal of biomolecular screening, Jul, Volume: 19, Issue:6
A High-Throughput Assay to Identify Inhibitors of the Apicoplast DNA Polymerase from Plasmodium falciparum.
AID1794808Fluorescence-based screening to identify small molecule inhibitors of Plasmodium falciparum apicoplast DNA polymerase (Pf-apPOL).
AID602156Novartis GNF Liver Stage Dataset: Malariabox Annotation2011Science (New York, N.Y.), Dec-09, Volume: 334, Issue:6061
Imaging of Plasmodium liver stages to drive next-generation antimalarial drug discovery.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (471)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's20 (4.25)18.2507
2000's134 (28.45)29.6817
2010's243 (51.59)24.3611
2020's74 (15.71)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 73.20

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index73.20 (24.57)
Research Supply Index6.42 (2.92)
Research Growth Index5.28 (4.65)
Search Engine Demand Index126.55 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (73.20)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials123 (25.26%)5.53%
Reviews34 (6.98%)6.00%
Case Studies25 (5.13%)4.05%
Observational4 (0.82%)0.25%
Other301 (61.81%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (169)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 2 Interventional, Multicenter, Randomized Open Label Study to Determine the Effective and Tolerable Dose of KAF156 and Lumefantrine Solid Dispersion Formulation in Combination, Given Once Daily for 1, 2 and 3-days to Adults and Children With Uncom [NCT03167242]Phase 2524 participants (Actual)Interventional2017-08-02Completed
A Multicentre Randomised Comparative Clinical Trial of the Efficacy of Artesunate + Amodiaquine Versus Artemether-lumefantrine (Coartem®) for the Treatment of Uncomplicated Childhood Plasmodium Falciparum Malaria in Zanzibar [NCT03768908]Phase 4359 participants (Actual)Interventional2005-01-05Completed
Surveillance for the Effectiveness and Safety of Artemether-lumefantrine in Pediatric and Adult Patients With Malaria [NCT01228344]324 participants (Actual)Observational2010-05-01Completed
A Phase 2, Multi-center, Randomized, Open-label, Dose-escalation Study to Determine Safety of Single (QD) and Multiple (3 QD) Doses of KAE609, Given to Adults With Uncomplicated Plasmodium Falciparum Malaria. [NCT03334747]Phase 2188 participants (Actual)Interventional2017-11-16Completed
Artemether-lumefantrine vs Chloroquine in Patients With Acute Non-severe P. Vivax Malaria in Sabah, Malaysia [NCT02348788]Phase 398 participants (Anticipated)Interventional2015-01-31Recruiting
A Phase I, Open-label, Fixed-sequence, Two-period, Crossover, Drug-drug Interaction Study to Investigate the Effect of Efavirenz on the Pharmacokinetics of Ganaplacide and Lumefantrine Combination in Healthy Participants [NCT05330273]Phase 114 participants (Actual)Interventional2022-04-28Completed
Efficacy and Safety of a Single Low-dose Primaquine Added to Standard Artemether-lumefantrine Treatment for the Clearance of Plasmodium Falciparum Gametocytes. [NCT02090036]Phase 4220 participants (Actual)Interventional2014-07-31Completed
A Four-arm Trial Comparing Artemether-lumefantrine With or Without Single-dose Primaquine and Sulphadoxine-pyrimethamine/Amodiaquine With or Without Single-dose Tafenoquine to Reduce P. Falciparum Transmission in Mali [NCT05081089]Phase 280 participants (Actual)Interventional2021-10-12Completed
Host and Parasites Factors Contributing to Risk of Plasmodium Re-infection and Morbidity in Elementary School Children in Maprik, East Sepik Province [NCT02143934]Phase 4524 participants (Actual)Interventional2009-08-31Completed
A Randomized Clinical Trial to Measure the Impact of Retreatment With an Artemisinin-based Combination on Malaria Incidence and Its Potential Selection of Resistant Strains [NCT01374581]Phase 32,117 participants (Actual)Interventional2012-05-31Completed
Efficacy and Safety of Artemether-lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Philippines in 2017-2018 [NCT05958810]80 participants (Actual)Observational2017-01-02Completed
Optimizing the Dose of Tafenoquine for the Radical Cure of Plasmodium Vivax Malaria in Southeast Asia [NCT04704999]Phase 4700 participants (Anticipated)Interventional2023-09-18Not yet recruiting
A Phase I, Open-label, Fixed Sequence, Two-period, Crossover, Drug-drug Interaction Study to Investigate the Interaction Potential of Itraconazole on the Pharmacokinetics of Ganaplacide and Lumefantrine Combination in Healthy Participants [NCT05084651]Phase 119 participants (Actual)Interventional2021-11-18Completed
Evaluation of the Safety of Primaquine in Combination With Artemether-lumefantrine in Glucose-6-phosphate Dehydrogynase Deficient Males With an Asymptomatic Malaria Infection in Burkina Faso (SAFEPRIM) [NCT02174900]Phase 2/Phase 370 participants (Actual)Interventional2014-10-31Completed
Clinical Efficacy of Artemisinin-based Combination Therapy for Treatment of Uncomplicated Plasmodium Falciparum Malaria in North Sumatera, Indonesia and the Association of Molecular Markers With Treatment Outcomes [NCT02325180]Phase 4338 participants (Actual)Interventional2015-01-31Completed
An Open-label Randomised Trial to Assess the Therapeutic Efficacy and Tolerability of Arterolane-piperaquine Plus Single Low Dose Primaquine Versus Arterolane-piperaquine Plus Mefloquine and Single Low Dose Primaquine Versus Artemether-lumefantrine Plus S [NCT03452475]Phase 3219 participants (Actual)Interventional2018-03-07Completed
A Randomised, Open-label Non-inferiority Trial of Artemether-lumefantrine Versus Quinine for the Treatment of Uncomplicated Falciparum Malaria During Pregnancy, Mbarara, Uganda (2006-2007) [NCT00495508]Phase 4300 participants (Actual)Interventional2006-10-31Completed
Efficacy of Antimalarial Drugs Used for the Treatment of Uncomplicated Malaria, Plasmodium Falciparum, at the Agadez, Gaya and Tessaoua Sentinel Sites [NCT05070520]Phase 4259 participants (Actual)Interventional2020-09-01Completed
Evaluation of the Efficacy of Artemether-lumefantrine and Dihydroartemisinin-piperaquine in Children With Uncomplicated Clinical Malaria in Rural Rwanda [NCT04767217]Phase 4528 participants (Anticipated)Interventional2021-06-14Recruiting
Efficacy and Safety of Artemether-lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria and Chloroquine for Plasmodium Vivax in the Philippines From 2013-2014 [NCT04222088]159 participants (Actual)Observational2013-05-01Completed
Safety and Feasibility of a Malaria Transmission Model in Semi-immune Kenyan Adults Using Plasmodium Falciparum Sporozoites [NCT04280692]Phase 1/Phase 244 participants (Actual)Interventional2022-08-22Active, not recruiting
Monitoring the Effectiveness and Safety of Artesunate-Amodiaquine and Artemether-Lumefantrine During the Treatment of Uncomplicated Plasmodium Falciparum Malaria Among Children in Yaounde, Cameroon [NCT04565184]Phase 4242 participants (Actual)Interventional2019-05-09Completed
Phase I, Randomized, Parallel Group Study to Evaluate the Effect of Multiple Oral Doses of Eurartesim on the QT/QTc Interval Compared to Riamet, Placebo and Moxifloxacin in Healthy Male and Female Volunteers [NCT01103830]Phase 1287 participants (Actual)Interventional2010-02-28Completed
Impact Tanzania in Vivo Efficacy 2010: Assessing the Efficacy of Artemisinin Combination Therapies for Treatment of Uncomplicated Malaria Infection in Children Aged 6-59 Months [NCT01082705]Phase 3323 participants (Actual)Interventional2010-04-30Completed
A Multi-center, Open-label, Randomized Trial of Chloroquine, Artemether-Lumefantrine, and Mefloquine-Artesunate for the Treatment of Uncomplicated P. Vivax Malaria in Pregnant Women in Brazil [NCT01107145]Phase 416 participants (Actual)Interventional2011-02-28Terminated(stopped due to Extremely slow enrollment)
An Adaptive, Randomized, Active-controlled, Open-label, Sequential Cohort, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Intravenous Cipargamin (KAE609) in Adult and Pediatric Participants With Severe Plasmodium [NCT04675931]Phase 2252 participants (Anticipated)Interventional2022-03-07Recruiting
Antioxidant Micronutrients in Malaria:a Randomised Clinical Trial [NCT01152931]Phase 310 participants (Actual)Interventional2010-08-31Completed
Randomized Study of the Tolerability and Efficacy of Artemether-Lumefantrine Versus Artesunate Plus Amodiaquine Coadministered for the Treatment of Uncomplicated Falciparum Malaria in Zanzibar [NCT03764527]Phase 4408 participants (Actual)Interventional2002-11-01Completed
Assessing the Effectiveness of Targeted Active Case Detection Among High Risk Populations in Southern Lao PDR [NCT03783299]Phase 439,968 participants (Actual)Interventional2017-11-28Completed
A Cluster Randomized, Single-centre, Controlled, Parallel,12-month Prospective Study and Additional 12-month Follow-up in Africa of Malaria Incidence in a Community Setting Following Systematic Treatment of P. Falciparum Asymptomatic Carriers With Artemet [NCT01256658]Phase 414,075 participants (Actual)Interventional2010-11-30Completed
Open Label, Multicenter Study for Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets (6-Dose Regimen) in African Infants and Children in the Treatment of Acute Uncomplicated Falciparum Malaria [NCT00709969]Phase 3310 participants (Actual)Interventional2002-07-31Completed
Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs [NCT00720811]6,456 participants (Actual)Interventional2009-10-31Completed
Phase 2/3, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Children In Africa [NCT00677833]Phase 2/Phase 3361 participants (Actual)Interventional2008-06-30Completed
Evaluation of the Effect of Artemisinin-based Combination Therapies on Urinary Schistosoma Haematobium When Administered for the Treatment of Malaria Co-infection [NCT04264130]Phase 254 participants (Actual)Interventional2018-07-31Completed
In Vivo and in Vitro Efficacy of the Recommended First Line Antimalarial Treatments (Artemether-Lumefantrine and Amodiaquine-Artesunate) in Children With Uncomplicated Malaria in Burkina Faso [NCT00808951]Phase 4440 participants (Actual)Interventional2008-12-31Completed
Safety and Protective Efficacy of Chemoprophylaxis and Sporozoite Immunization With Plasmodium Falciparum NF135 Against Homologous and Heterologous Challenge Infection in Healthy Volunteers in the Netherlands [NCT03813108]43 participants (Actual)Interventional2019-04-01Terminated(stopped due to Subject withdrawals after temporal suspension of the trial (for personal, logistic reasons). At time of reinitiation the number of enrolled subjects did not meet the predefined threshold for continuation of the trial.)
Phase III Clinical Trials of Artemisinin-based Combination Therapy in Cameroon [NCT00297882]Phase 3816 participants (Actual)Interventional2006-07-31Completed
[NCT00868465]600 participants (Anticipated)Interventional2009-04-30Completed
Efficacy and Safety of Artesunate-amodiaquine and Artemether-lumefantrine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Democratic Republic of the Congo: a Randomized Controlled Trial (TES2022) [NCT06076213]Phase 41,408 participants (Anticipated)Interventional2023-05-01Recruiting
Pharmacokinetics of Drugs Used to Treat Uncomplicated Malaria in Breastfeeding Mother-infant Pairs: An Observational Pharmacokinetic Study [NCT05676645]30 participants (Anticipated)Observational2023-03-20Recruiting
A Five-arm Trial Comparing Artesunate-amodiaquine and Artemether-lumefantrine-amodiaquine With or Without Single-dose Primaquine to Reduce P. Falciparum Transmission in Mali [NCT05550909]Phase 2100 participants (Actual)Interventional2022-10-17Completed
Open Label Randomized Study Evaluating the in Vivo Efficacies of Artemether-lumefantrine and Dihydroartemisinin-piperaquine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Under Five Years of Age in Western Kenya [NCT05060198]340 participants (Actual)Interventional2016-06-17Completed
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity [NCT05757167]Phase 42,500 participants (Anticipated)Interventional2023-11-06Recruiting
Evaluation of Dolutegravir Interactions With Artemether-Lumefantrine and Amodiaquine-Artesunate [NCT02242799]Phase 146 participants (Actual)Interventional2015-06-30Completed
Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Five Years After Wide Scale Use of the Drug in Tanzania. [NCT02089841]Phase 4140 participants (Actual)Interventional2012-05-31Completed
In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate for the Treatment of Uncomplicated Falciparum Malaria in Children: A Multisite, Open-label, Two-cohort Clinical Trial in Mozambique. [NCT02168569]Phase 4700 participants (Actual)Interventional2011-06-30Completed
A Five-cohort, Randomized, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics of a Single Dose of Tafenoquine (SB252263) 300mg When Co-administered With the Artemisinin-based Combination Therapies (ACT) Artemether + Lumefantrine (AL) and Di [NCT02184637]Phase 1120 participants (Actual)Interventional2014-07-31Completed
Efficacy and Safety of Artemether Lumefantrine Combination Therapy for the Treatment of Malaria Due to Plasmodium Ovale, Plasmodium Malariae, and Mixed Plasmodium Infections in Gabon [NCT00725777]40 participants (Actual)Interventional2008-07-31Completed
A Multi-center, Open-label, Randomized, Phase 4, Trial of Artemether-Lumefantrine and Mefloquine-Artesunate for the Treatment of Uncomplicated P. Falciparum Malaria Parasitemia in Pregnant Women in Brazil [NCT01082731]Phase 46 participants (Actual)Interventional2010-11-30Terminated(stopped due to Extremely slow enrollment)
An Open-label, Randomized, Single-center, Parallel Group Study of the Effects of Artemether-lumefantrine (Coartem®) Atovaquone-proguanil (Malarone®) and Artesunate-mefloquine on Auditory Function Following the Treatment of Acute Uncomplicated Plasmodium F [NCT00444106]Phase 4265 participants (Actual)Interventional2007-05-31Completed
Extended Duration Artemether-lumefantrine Treatment for Malaria in Children [NCT03453840]Phase 4305 participants (Actual)Interventional2018-02-19Completed
Ethiopia In-vivo Efficacy Study 2009: Evaluating the Efficacy of Artemether-lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Infection and Either Artemether-lumefantrine or Chloroquine for P. Vivax Infection [NCT01052584]354 participants (Actual)Interventional2009-10-31Completed
Feasibility of Methylene Blue-based Combination Therapy in the Radical Treatment of Adult Patients With Plasmodium Vivax Malaria in Ethiopia: a Randomised Controlled Pilot Trial [NCT02696928]Phase 20 participants (Actual)Interventional2016-04-30Withdrawn(stopped due to Lack of ethical approval in Ethiopia)
Targeting Malaria High-risk Populations With Tailored Intervention Packages: A Study to Assess Feasibility and Effectiveness in Northern Namibia [NCT04094727]Phase 43,302 participants (Actual)Interventional2019-10-31Completed
A Randomized, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions of Orally Administered Artemether-lumefantrine, Amodiaquine and Primaquine in Healthy Adult Subjects [NCT02696954]Phase 1/Phase 217 participants (Actual)Interventional2016-11-18Terminated
In Vivo Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for the Treatment of Uncomplicated Falciparum Malaria: an Open-randomised, Non-inferiority Clinical Trial in South Kivu, DR Congo [NCT02741024]Phase 4288 participants (Actual)Interventional2013-10-31Completed
Lumefantrine Pharmacokinetics When Administered as a Fixed Dose Combination With Artemether in HIV Positive Patients on Lopinavir/Ritonavir [NCT00619944]Phase 432 participants (Anticipated)Interventional2008-02-29Completed
Pharmacokinetic Interaction Between Coartem® and Either Nevirapine, Efavirenz or Rifampicin in HIV Positive Ugandan Patients [NCT00620438]Phase 490 participants (Anticipated)Interventional2008-02-29Active, not recruiting
Evaluation of the Effect of Targeted Mass Drug Administration and Reactive Case Detection on Malaria Transmission and Elimination in East Hararghe Zone, Oromia, Ethiopia [NCT04241705]48,960 participants (Anticipated)Interventional2020-01-20Recruiting
Study of Therapeutic Efficacy, Safety and Pharmacokinetic Interactions Between Artemether-lumefantrine and Nevirapine-based Antiretrovirals in HIV-infected Patients With Uncomplicated Falciparum-malaria in Muheza, Northeastern Tanzania [NCT00885287]Phase 4830 participants (Actual)Interventional2009-07-31Completed
Programmatic Implementation of ACTs in Malawi: Safety and Effectiveness of Combination Therapies With Repeated Treatments for Uncomplicated P. Falciparum Malaria Over a Three-year Period [NCT01038063]Phase 41,200 participants (Anticipated)Interventional2010-10-31Recruiting
Phase III Comparative, Open-labelled, Randomised, Clinical Study to Assess a Fixed Dose of Oral Pyronaridine Artesunate Granule Formulation vs. Coartem® Crushed Tablets in Infants With Acute Uncomplicated Plasmodium Falciparum Malaria [NCT00541385]Phase 3535 participants (Actual)Interventional2007-10-31Completed
Artemether-lumefantrine Vs Co-formulated Amodiaquine + Artesunate for the Treatment of Uncomplicated Falciparum Malaria: a Randomized Open-label Trial to Evaluate the Effectiveness of the Burkina Faso New Drug Policy [NCT01017770]Phase 4340 participants (Anticipated)Interventional2008-09-30Completed
Effectiveness and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for the Treatment of Uncomplicated Malaria in Guinea-Bissau [NCT04897919]Phase 4474 participants (Actual)Interventional2015-08-01Completed
A Randomized Trial of Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria in Tanzanian Children. [NCT00694694]Phase 3261 participants (Actual)Interventional2008-06-30Completed
Pharmacokinetic Interactions Between Antiretroviral Agents, Lopinavir/Ritonavir and Efavirenz and Antimalarial Drug Combinations, Artesunate/Amodiaquine and Artemether/Lumefantrine. [NCT00697892]Phase 138 participants (Actual)Interventional2005-07-31Completed
An Open-label, Randomised, Controlled, Non-inferiority Trial to Compare the Efficacy, Safety and Tolerability of a Fixed Dose Triple Artemisinin-based Combination Therapy (TACT) Artemether-lumefantrine-amodiaquine Versus First-line Artemisinin-based Combi [NCT05951595]Phase 31,440 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Pharmacokinetic Interaction Between the Antimalarial Combination Artemether/Lumefantrine and Combination Antiretroviral Therapy Including Nevirapine in HIV-infected Adults [NCT00790881]Phase 436 participants (Anticipated)Interventional2008-10-31Completed
Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria [NCT00852423]Phase 33,428 participants (Actual)Interventional2010-06-30Completed
A Multi-centre Randomised Controlled Non-inferiority Trial to Compare the Efficacy, Safety and Tolerability of Triple Artemisinin-based Combination Therapies Versus First-line ACTs + Placebo for the Treatment of Uncomplicated Plasmodium Falciparum Malaria [NCT03939104]Phase 31,368 participants (Anticipated)Interventional2021-06-30Recruiting
A Multi-centre Randomised Controlled Non-inferiority Trial to Compare the Efficacy, Safety and Tolerability of Triple Artemisinin-based Combination Therapies Versus First-line ACTs + Placebo for the Treatment of Uncomplicated Plasmodium Falciparum Malaria [NCT03923725]Phase 33,240 participants (Anticipated)Interventional2020-09-01Recruiting
Evaluation of 4 Artemisinin-based Combinations for Treating Uncomplicated Malaria in African Children [NCT00393679]Phase 34,112 participants (Actual)Interventional2007-07-31Completed
[NCT01075945]Phase 4140 participants (Anticipated)Interventional2010-02-28Recruiting
A Phase 1 Clinical Trial To Evaluate The Safety and Infectivity Of Direct Venus Inoculation of Aseptic, Purified, Cryopreserved Plasmodium Falciparum 7G8 And NF54 Challenge Strains (PfSPZ) in a Head-To-Head Comparative Study [NCT04203186]0 participants (Actual)Interventional2020-03-31Withdrawn(stopped due to Funding was lost due to the COVID19 Pandemic)
A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of Glucose-6-dehydrogenase Status in South-east Bangladesh [NCT02389374]Phase 4181 participants (Actual)Interventional2014-08-31Completed
Comparison of Lumefantrine Concentrations Measured in Venous Plasma Versus in Dried Capillary Blood Spot Samples in Healthy Volunteers. [NCT02742285]Phase 416 participants (Actual)Interventional2016-05-31Completed
In-vivo Efficacy and Safety of Artemether/Lumefantrine Vs Dihydroartemisinin-piperaquine for Treatment of Uncomplicated Malaria and Assessment of Parasite Genetic Factors Associated With Parasite Clearance or Treatment Failure [NCT02590627]Phase 4509 participants (Actual)Interventional2014-05-31Completed
An Open-label, Single-center Study of the Effects of Co-artemether, Atovaquone-proguanil, and Artesunate-mefloquine on Auditory Function Following the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Patients 12 Years of Age or Older. [NCT00386750]Phase 4265 participants Interventional2005-06-30Terminated
A Randomized Open-Label Trial of the Efficacy of Artemether-Lumefantrine Suspension Compared With Artemether-Lumefantrine Tablets for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Less Than Five Years in Western Kenya [NCT00529867]Phase 4267 participants (Actual)Interventional2007-05-31Completed
Interactions Between HIV and Malaria in African Children [NCT00527800]Phase 3351 participants (Actual)Interventional2007-08-31Completed
Optimizing Malaria Treatment for HIV-Malaria Co-Infected Individuals by Addressing Drug Interactions Between Artemether-Lumefantrine and Efavirenz; a Randomized Controlled Trial [NCT04708496]Phase 4888 participants (Anticipated)Interventional2021-01-18Recruiting
Assessment of Adherence to a 6-Dose Regimen of Coartem for Treatment of Uncomplicated Malaria in Children Under 5 Years in Tanzania [NCT00153491]300 participants Observational2002-08-31Completed
Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children [NCT00540202]Phase 4302 participants (Anticipated)Interventional2007-09-30Recruiting
A Phase III Comparative (Double-blind, Double-dummy) Randomised, Multi-centre Study to Assess the Efficacy of Pyronaridine Artesunate (180:60mg) Versus Coartem® (Artemether Lumefantrine) in Children & Adult Patients With Falciparum Malaria [NCT00422084]Phase 31,272 participants (Actual)Interventional2007-01-31Completed
Treatment Outcomes for Non-malarial Febrile Illness in Children Aged 6-59 Months in Areas of Perennial Malaria Transmission [NCT01043744]1,000 participants (Actual)Interventional2010-01-31Completed
Efficacy and Safety of the Dispersible Formulation of Artemether-lumefantrine, Co-formulated Artesunate-amodiaquine and Co-formulated Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Machinga District, Mal [NCT01326754]498 participants (Actual)Interventional2011-08-31Completed
A Phase I, Partially Randomized, Open Label, Two-way, Two Period Cross-over Study to Investigate the Pharmacokinetic Interaction Between Etravirine or Darunavir/Rtv and Artemether/Lumefantrine at Steady-state in Healthy HIV-negative Subjects [NCT01876966]Phase 133 participants (Actual)Interventional2011-03-31Completed
THE OPTIMAL TIMING OF PRIMAQUINE TO PREVENT MALARIA TRANSMISSION AFTER ARTEMISININ-COMBINATION THERAPY [NCT01906788]Phase 4250 participants (Anticipated)Interventional2013-05-31Recruiting
Comparison of Two Regimens of Artemether-lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Pregnant Women in the Democratic Republic of Congo [NCT01916954]Phase 396 participants (Actual)Interventional2013-07-31Completed
A Double Blind Randomized Controlled Trial to Assess the Efficacy and Safety of Low Dose Primaquine for Clearance of Gametocytes in Asymptomatic Individuals Infected With P. Falciparum in Burkina Faso [NCT01935882]Phase 2/Phase 3360 participants (Actual)Interventional2013-09-30Completed
Treatment Efficacy and Malaria TRANSmission After Artemisinin Combination Therapy 2 (TRANSACT2) [NCT01939886]Phase 3219 participants (Actual)Interventional2013-04-30Completed
Community-based Scheduled Screening and Treatment of Malaria in Pregnancy for Improved Maternal and Infant Health: a Cluster-randomized Trial in The Gambia, Burkina Faso and Benin [NCT01941264]4,265 participants (Actual)Interventional2013-10-31Completed
Efficacy and Bio-availability of Artemether-Lumefantrine Fixed Combination in Severely Malnourished Children Compared to Non-severely Malnourished Children [NCT01958905]399 participants (Actual)Interventional2013-11-30Completed
Adherence to Artemisinin-Based Combination Therapy (ACT) for the Treatment of Malaria in Sierra Leone [NCT01967472]1,145 participants (Actual)Interventional2013-09-16Completed
In Vivo and In Vitro Efficacy of Artemisinin Combination Therapy in Kisumu County, Western Kenya [NCT01976780]Phase 4118 participants (Actual)Interventional2013-06-30Completed
Parasite Clearance Time and Time to Recurrent Infection Following Treatment With Artemether/Lumefantrine Among Children With Uncomplicated P. Falciparum Malaria Five Years After Wide Scale Use of the Drug in Tanzania [NCT01998295]Phase 445 participants (Actual)Interventional2012-05-31Completed
Artemether-lumefantrine vs Chloroquine in Patients With Acute Uncomplicated P. Knowlesi Malaria: a Randomized Open Label Trial in Sabah, Malaysia (CAN KNOW Trial) [NCT02001012]Phase 3123 participants (Actual)Interventional2014-01-31Completed
An Open-label Randomized Controlled Trial to Evaluate the Effectiveness and Safety of a 3 Day Versus 5 Day Course of Artemether-lumefantrine for the Treatment of Uncomplicated Falciparum Malaria in Myanmar [NCT02020330]Phase 3150 participants (Actual)Interventional2013-11-25Completed
A Randomized, Investigator-Blinded, Multicenter, Parallel-Group Study to Compare Efficacy, Safety and Tolerability of Arthemeter/ Lumefantrine Dispersible Tablet Formulation vs. Artemether/ Lumefantrine 6-Dose Crushed Tablet in the Treatment of Acute Unco [NCT00386763]Phase 3890 participants Interventional2006-08-31Completed
Impact of a School-based Programme of Malaria Diagnosis and Treatment on School Attendance in Southern Malawi [NCT02213211]3,667 participants (Actual)Interventional2014-04-30Completed
Efficacy and Safety of Artemether-lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Philippines in 2015 [NCT05958693]82 participants (Actual)Observational2015-01-05Completed
A Phase 2 Interventional, Multicenter, Randomized, Open-label Study in Three Age-descending Cohorts to Evaluate Efficacy, Safety and Tolerability of KAF156 and Lumefantrine-SDF Combination in the Treatment of Acute Uncomplicated Plasmodium Falciparum Mala [NCT04546633]Phase 2295 participants (Anticipated)Interventional2021-02-16Recruiting
A Double Blind Randomized Controlled Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission [NCT01603251]Phase 1/Phase 2120 participants (Actual)Interventional2013-01-31Completed
Pharmacokinetic Interaction Between the Antimalarial Combination Artemether/Lumefantrine and Combination Antiretroviral Therapy Including Lopinavir/Ritonavir in HIV-infected Adults [NCT00869700]Phase 418 participants (Actual)Interventional2009-06-30Completed
In Vivo Efficacy of Artemether-Lumefantrine and Artesunate-Amodiaquine for Uncomplicated Plasmodium Falciparum Malaria in Malawi, 2014 [NCT02637128]Phase 4452 participants (Actual)Interventional2014-03-31Completed
Comparative Evaluation of the Safety and the Efficacy of Artemether + Lumefantrine (Coartem™) vs. Sulfadoxine + Pyrimethamine (SP) in Both HIV+ and HIV- Adults With Uncomplicated P. Falciparum Malaria in Zambia [NCT00304980]3,000 participants Interventional2003-03-31Terminated
A Randomized Study to Compare Artesunate + Amiodaquine Versus Artemether + Lumefantrine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks Occurring During 2 Years in a Cohort in Senegal [NCT00540410]Phase 4366 participants (Actual)Interventional2007-09-30Completed
Efficacy and Safety of Artemether-Lumefantrine and Dihydroartemisinin-Piperaquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria Among Children in the North Region of Cameroon [NCT05340153]Phase 4184 participants (Anticipated)Interventional2022-04-11Not yet recruiting
Phase 2 Proof of Concept Study of a Candidate Aminoquinoline Antimalarial (AQ-13) [NCT01614964]Phase 266 participants (Actual)Interventional2013-08-31Completed
Multicenter, Open-label, Single-arm Study to Evaluate the PK, Safety, Tolerability and Efficacy of a New Artemether:Lumefantrine (2.5 mg:30 mg) Dispersible Tablet in the Treatment of Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodi [NCT04300309]Phase 2/Phase 328 participants (Actual)Interventional2020-12-21Active, not recruiting
A Pilot, Double-blind, Randomized, Parallel-group, Placebo-controlled, Exploratory Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy ( [NCT04020653]Phase 20 participants (Actual)Interventional2019-09-06Withdrawn(stopped due to Considering the Thai FDA requirement, changes of Malaria cases in Thailand and EC recommendation, the decision to withdrawal the study was made.)
A Multi-centre, Randomised, Double-blind, Double Dummy Study Comparing the Efficacy and Safety of Chlorproguanil-dapsone-artesunate Versus Artemether-lumefantrine in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children and Adoles [NCT00344006]Phase 31,395 participants (Actual)Interventional2006-06-30Completed
Effectiveness of Artemether-Lumefantrine Treatment Provided by Community Health Worker Against Uncomplicated Malaria in Children Under 5 Years of Age in Tanzania [NCT00454961]Phase 4200 participants (Anticipated)Interventional2007-04-30Completed
Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso [NCT04695197]Phase 3142 participants (Anticipated)Interventional2021-01-08Recruiting
Longitudinal Comparison of Combination Antimalarial Therapies in Ugandan Children: Evaluation of Safety, Tolerability, and Efficacy [NCT00123552]Phase 3601 participants (Actual)Interventional2004-11-30Completed
Characterization of Novel Molecular Tools for the Epidemiological Surveillance of Antimalarial Drug Resistance in Mali [NCT00127998]1,011 participants Interventional2005-07-31Completed
Chloroquine and Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Guinea Bissau. [NCT00426439]Phase 4300 participants (Anticipated)Interventional2006-12-31Completed
Sulfadoxine-Pyrimethamine Versus Artemether-Lumefantrine Versus Amodiaquine-Artesunate Coformulation in Uncomplicated Plasmodium Falciparum Malaria : an Open Randomized Study [NCT00460369]240 participants (Actual)Interventional2007-04-30Completed
Randomized Trial of the Safety and Effectiveness of Lapdap and Coartemether for Uncomplicated Malaria in Operational Settings [NCT00118794]Phase 31,200 participants Interventional2004-09-30Completed
Assessing and Monitoring the Efficacy of Sulfadoxine/ Pyrimethamine (SP) and the Combination of SP Plus Artesunate for Uncomplicated Malaria Infections Among Children [NCT00140361]Phase 4390 participants (Actual)Interventional2000-01-31Completed
[NCT00406146]Phase 30 participants Interventional2004-10-31Active, not recruiting
Can Triple Artemisinin-based Combination Therapy for Treatment of Uncomplicated Plasmodium Falciparum Malaria, Delay Drug Resistance Development of Plasmodium Falciparum in Tanzania: a Randomized Three Arm Clinical Trial [NCT05764746]Phase 2/Phase 3384 participants (Anticipated)Interventional2023-04-01Not yet recruiting
Open Label Study to Evaluate Combination Anti-malarial Therapy,in Terms of Efficacy, Prevalence of Gametocyte Carriage and Molecular Markers Associated With Sulfadoxine Pyrimethamine Resistance in Uncomplicated Plasmodium Falciparum [NCT00203801]700 participants Interventional2002-01-31Completed
Assessment of the Public Health Benefit of Artemisinine Based Combination Therapies for Uncomplicated Malaria Treatment in Mali [NCT00452907]Phase 4780 participants (Actual)Interventional2005-07-31Completed
Efficacy and Safety of Artesunate-amodiaquine, Artemether-lumefantrine and Dihydroartemisinine-piperaquine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Democratic Republic of Congo: a Randomized Controlled Trial [NCT02940756]Phase 41,615 participants (Actual)Interventional2017-03-15Completed
Efficacy and Safety of Artesunate-amodiaquine (ASAQ) and Artemether-lumefantrine (AL) for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Center Region of Cameroon [NCT04829695]Phase 4184 participants (Anticipated)Interventional2021-04-05Not yet recruiting
An Open Randomised Trial of the Efficacy of Sulfadoxine-Pyrimethamine (SP), Amodiaquine + SP (AQ-SP), AQ + Artesunate (AQ-Art), Chlorproguanil-Dapsone + Art (CD-Art), and Lumefantrine-Artemether (LA) for Uncomplicated Malaria in Malawi [NCT00164710]Phase 4365 participants Interventional2005-04-30Completed
Pharmacology of Artemisinin-Based Antimalarial Therapy Within the Context of Antiretroviral Therapy [NCT01728961]Phase 419 participants (Anticipated)Interventional2012-02-29Terminated(stopped due to Slow accrual and funding limitations.)
Pharmacokinetic Interactions Between Antiretroviral Agents, Lopinavir/Ritonavir and Efavirenz and Antimalarial Drug Combination, Artemether/Lumefantrine [NCT00266058]Phase 133 participants (Actual)Interventional2005-12-31Completed
Effect of Atazanavir-ritonavir on the Pharmacokinetics and Toxicity of Lumefantrine in People Living With HIV Attending Lagos University Teaching Hospital [NCT04531072]Phase 420 participants (Actual)Interventional2018-09-18Completed
Ethiopia Antimalarial in Vivo Efficacy Study 2012: Evaluating the Efficacy of Artemether-lumefantrine Alone Compared to Artemether-lumefantrine Plus Primaquine and Chloroquine Alone Compared to Chloroquine Plus Primaquine for Plasmodium Vivax Infection [NCT01680406]Phase 4398 participants (Actual)Interventional2012-10-31Completed
[NCT00451139]Phase 40 participants InterventionalCompleted
Treatment of Uncomplicated Childhood Malaria by an Artemisinin Derivative in Combination With Lumefantrine. Efficacy, Safety and Genotyping. [NCT00336375]Phase 450 participants (Actual)Interventional2006-06-30Completed
Artemether/Lumefantrine in the Treatment of Plasmodium Vivax Malaria in Eastern Sudan [NCT01625871]Phase 338 participants (Actual)Interventional2011-09-30Completed
An Individually Randomised Trial of Seasonal Malaria Chemoprevention Versus a Long-acting Artemisinin Combination Therapy for the Prevention of Malaria and Anaemia in Children Living in an Area of Extended Seasonal Transmission in Ghana. [NCT01651416]Phase 42,400 participants (Actual)Interventional2012-07-31Completed
Efficacy of Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso [NCT01697787]Phase 4150 participants (Actual)Interventional2012-10-31Completed
Efficacy and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for the Treatment of Uncomplicated Malaria in Guinea-Bissau. [NCT01704508]Phase 4346 participants (Actual)Interventional2012-11-30Completed
Efficacy of Artesunate-amodiaquine, Dihydroartemisinin-piperaquine and Artemether-lumefantrine Combination Therapies for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Aged 6 to 59 Months in Maradi, Niger 2012-13 [NCT01755559]Phase 4663 participants (Actual)Interventional2013-06-30Completed
Efficacy of Dried Leaf Artemisia (DLA) Versus Coartem (ACT): A Randomized Controlled Clinical Trial for Comparing DLA vs. ACT to Treat Malaria [NCT03199755]Phase 20 participants (Actual)Interventional2018-08-20Withdrawn(stopped due to Withdrawn in 2018 because clinicians did not follow protocols, issues with communication and also with tablet processing, nearby Ebola outbreak in 2018 (in the N Kivu area) confounded efforts.)
Phase III Study to Study the Clinical Response to ACT Fixed Dose Combination in 42 Days in Uncomplicated Malaria in Cameroon [NCT01845701]Phase 3720 participants (Actual)Interventional2010-03-31Completed
A Comparative Assessment of the Effectiveness of Artemether Plus Lumefantrine Versus Artesunate Plus Amodiaquine for the Treatment of Children With Uncomplicated Plasmodium Falciparum Malaria [NCT00374205]Phase 4245 participants (Actual)Interventional2006-09-30Terminated(stopped due to Interim analysis showed more LCFs in one of the treatment arms)
A Single Centre, Open Label, Pilot Phase Ib Study to Investigate Blood Stage Malaria Infection After Direct Venous Inoculation of Cryopreserved P. Falciparum (NF54 Strain) Sporozoites (PfSPZ-DVI) in Malaria naïve Healthy Adult Volunteers [NCT04310085]Phase 116 participants (Actual)Interventional2020-02-19Completed
A Proof-of-concept Study to Assess the Effect of ACT-451840 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Subjects [NCT02223871]Phase 18 participants (Actual)Interventional2014-06-30Completed
An Open-label, Randomized Multicenter Study to Investigate the Anti-parasitic Activity, Pharmacokinetic and Safety of IM SAR97276A With Oral ACTs as Positive Control in Children Presenting With Symptomatic Plasmodium Falciparum Uncomplicated Malaria [NCT01445938]Phase 220 participants (Actual)Interventional2011-10-31Terminated(stopped due to Data Monitoring Committee recommendation)
Cluster Randomized Trial of Malaria Seasonal IPTc Combined With Community Case Management in Saraya District, SE Senegal [NCT01449045]Phase 34,554 participants (Actual)Interventional2011-07-31Completed
Evaluation of Safety and Efficacy of Maytenus Senegalensis for the Treatment of Uncomplicated Malaria Episodes in Adult Patients as Compared to Artemether-lumefantrine [NCT04944966]Phase 212 participants (Actual)Interventional2021-06-02Completed
Evaluation of Three Artemisinin-based Combinations for the Treatment of Uncomplicated Malaria in Childreen in Burkina Faso (CHIMIO2) [NCT04778813]Phase 41,050 participants (Anticipated)Interventional2021-06-01Not yet recruiting
Ivermectin-artemisinin Combination Therapy for Eradication of Malaria [NCT05605925]Phase 4138 participants (Anticipated)Interventional2022-08-04Recruiting
Comparative Efficacy and Safety of Pyronaridine-Artesunate Versus Artemether-Lumefantrine in The Treatment of Acute Uncomplicated Malaria Among Children In South-West Nigeria [NCT05192265]Phase 2/Phase 3172 participants (Actual)Interventional2019-05-20Completed
Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Uncomplicated Falciparum Malaria in Western Kenya [NCT02411994]Phase 3197 participants (Actual)Interventional2015-10-31Completed
Epidemiology of Malaria in Malawi: Human Hosts and Parasites in Three Districts Part 2: Cross-sectional Surveillance (School-based Cohorts) [NCT04858087]786 participants (Actual)Observational2015-03-24Completed
A Randomized, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions of Orally Administered Artemether-lumefantrine and Amodiaquine in Healthy Adult Subjects [NCT04080895]Phase 116 participants (Anticipated)Interventional2022-11-01Recruiting
In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate for the Treatment of Uncomplicated Falciparum Malaria in Children: A Multisite Open Label, Two-cohort Clinical Trial in Mozambique [NCT04370977]Phase 4630 participants (Actual)Interventional2018-03-21Completed
The Impact of Intermittent Preventive Malaria Treatment With Artemisinin Combination Therapy (ACT) on Hemoglobin, Malaria, Schistosomiasis, and School Attention Among Primary Schoolchildren in the Kassena-Nankana Districts, Ghana [NCT01459146]Phase 4345 participants (Anticipated)Interventional2010-12-31Recruiting
Reducing the Burden of Malaria by Targeting Hotspots of Transmission and Improving Malaria Control Measures in the Highlands of Western Kenya: Simultaneous Rollout of Four Malaria Control Interventions and Evaluation by Cross-sectional Surveys [NCT01575613]17,506 participants (Actual)Interventional2012-04-30Completed
Artemether-Lumefantrine Clinical Effectiveness Study [NCT01599000]Phase 4159 participants (Actual)Interventional2011-03-31Completed
Evaluating the Efficacy of Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Cruzeiro do Sul, Acre, Brazil [NCT02600767]79 participants (Actual)Interventional2015-12-31Completed
A Randomised, Single Blind, Placebo Controlled, Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Activity of Ruxolitinib When Co-administered With Artemether-lumefantrine in Healthy Participants [NCT04456634]Phase 18 participants (Actual)Interventional2020-09-10Completed
Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety, Immunogenicity, and Protective Efficacy of Two Regimens of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Natural Transmission Season in Healthy Afric [NCT03510481]Phase 1478 participants (Actual)Interventional2018-05-14Completed
Efficacy and Safety of Artesunate-amodiaquine and Artemether-lumefantrine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Democratic Republic of the Congo: a Randomized Controlled Trial [NCT04618523]Phase 41,117 participants (Actual)Interventional2020-10-26Completed
"Aiming at Prolonging the Therapeutic Life Span of Artemisinin-based Combination Therapies (ACT) in an Era of Imminent Plasmodium Falciparum Resistance in Bagamoyo District, Tanzania - New Strategies With Old Tools" [NCT03241901]Phase 4280 participants (Actual)Interventional2017-07-27Completed
An Open-label, Single-arm Study to Evaluate the Efficacy, Safety and PK of Artemether-lumefantrine Dispersible Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants <5 kg Body Weight [NCT01619878]Phase 2/Phase 320 participants (Actual)Interventional2012-10-31Completed
An Open-label Individually Randomised Controlled Trial to Assess the Efficacy of Artemether-lumefantrine Prophylaxis for Malaria Among Forest Goers in Cambodia [NCT04041973]1,480 participants (Actual)Interventional2020-03-11Completed
Evaluation of the Efficacy of Artemisinin Combination Therapy in Kenya [NCT01899820]Phase 32,100 participants (Anticipated)Interventional2013-04-30Active, not recruiting
A Phase I, Open-label, Fixed-sequence, Two-period, Crossover, Drug-drug Interaction Study to Evaluate the Effect of Multiple Doses of Ganaplacide and Lumefantrine Combination on the Pharmacokinetics of Midazolam, Repaglinide, Dextromethorphan, Metformin, [NCT05236530]Phase 148 participants (Actual)Interventional2022-03-09Completed
Efficacy of Artemether Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DHP) for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Siaya and Bungoma Counties, Kenya [NCT04767191]Phase 4400 participants (Actual)Interventional2021-03-15Completed
Efficacy and Safety of Artemether Lumefantrine for the Treatment of Uncomplicated Malaria in Tanzania [NCT03387631]344 participants (Actual)Observational [Patient Registry]2016-04-30Completed
Field Study of the Pharmacokinetics and Pharmacodynamics of Artemisinin-based Combination Therapy for Gametocyte Clearance and Post-treatment Chemoprotection in Zambian Children With Uncomplicated Falciparum Malaria [NCT04009343]Phase 2/Phase 3182 participants (Anticipated)Interventional2019-06-19Active, not recruiting
Assessment of Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa [NCT02974348]Phase 3300 participants (Actual)Interventional2013-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00297882 (2) [back to overview]Cure Rate on Day 28
NCT00297882 (2) [back to overview]Cure Rate Day 14
NCT00422084 (8) [back to overview]Proportion of Patients With Parasite Clearance at Day 1, 2 and 3
NCT00422084 (8) [back to overview]Percentage of Patients With Fever Clearance at Day 1, 2 and 3
NCT00422084 (8) [back to overview]Crude ACPR (Non-PCR Corrected ACPR) on Day 14 and Day 28
NCT00422084 (8) [back to overview]Adverse Events and Clinically Significant Laboratory Results
NCT00422084 (8) [back to overview]PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28
NCT00422084 (8) [back to overview]PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 14
NCT00422084 (8) [back to overview]Parasite Clearance Time
NCT00422084 (8) [back to overview]Fever Clearance Time
NCT00444106 (4) [back to overview]Relationship Between Changes in Auditory Function and Treatment Groups
NCT00444106 (4) [back to overview]Efficacy of Polymerase Chain Reaction (PCR) Adjusted Malaria Cure Rates of the Three Treatment Regimens at Days 14, 28 and 42
NCT00444106 (4) [back to overview]Auditory Changes Following 3 Days of Treatment at Days 3, 7, 28, and 42 Days as Assessed by Pure Tone Thresholds Assessments (a Type of Hearing Test)
NCT00444106 (4) [back to overview]Percentage of Participants With Auditory Abnormalities at Day 7 Assessed by Auditory Brainstem Response (ABR) Wave III Latency Changes on Day 7(a Type of Hearing Test)
NCT00541385 (8) [back to overview]Percentage of Participants With PCR-Corrected ACPR on Day 28
NCT00541385 (8) [back to overview]Percentage of Participants With PCR-Corrected ACPR on Day 14
NCT00541385 (8) [back to overview]Parasite Clearance Time
NCT00541385 (8) [back to overview]Fever Clearance Time
NCT00541385 (8) [back to overview]Proportion of Subjects With Fever Cleared on Days 1, 2, and 3
NCT00541385 (8) [back to overview]Number of Subjects With ≥1 Adverse Event
NCT00541385 (8) [back to overview]Proportion of Subjects With Cleared Parasites on Days 1, 2, and 3
NCT00541385 (8) [back to overview]Crude ACPR (Non-PCR Corrected ACPR) (Crude Cure Rate) on Day 14 and Day 28
NCT00677833 (19) [back to overview]Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population
NCT00677833 (19) [back to overview]Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population
NCT00677833 (19) [back to overview]Time to Recurrence of Parasitemia
NCT00677833 (19) [back to overview]Change From Nadir Hemoglobin Level at Days 14, 28, and 42
NCT00677833 (19) [back to overview]Percentage of Participants With Gametocytologic Response
NCT00677833 (19) [back to overview]Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected)
NCT00677833 (19) [back to overview]Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected)
NCT00677833 (19) [back to overview]Percentage of Participants With LCF in PP Population (PCR-corrected)
NCT00677833 (19) [back to overview]Fever Clearance Time
NCT00677833 (19) [back to overview]Percentage of Participants With LPF in PP Population (PCR-corrected)
NCT00677833 (19) [back to overview]Percentage of Participants With PCR-uncorrected ACPR in the mITT Population
NCT00677833 (19) [back to overview]Percentage of Participants With PCR-corrected ACPR in PP Population
NCT00677833 (19) [back to overview]Percentage of Participants With PCR-corrected ACPR in the mITT Population
NCT00677833 (19) [back to overview]Percentage of Participants With PCR-uncorrected ACPR in PP Population
NCT00677833 (19) [back to overview]Percentage of Participants With Asexual Parasitologic Response (PCR-corrected)
NCT00677833 (19) [back to overview]Asexual Plasmodium Falciparum Parasite Clearance Time
NCT00677833 (19) [back to overview]Nadir Hemoglobin Level
NCT00677833 (19) [back to overview]Percentage of Participants With Early Treatment Failure (ETF) in the mITT Population (PCR-corrected)
NCT00677833 (19) [back to overview]Percentage of Participants With ETF in PP Population (PCR-corrected)
NCT01256658 (22) [back to overview]Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Day 1 to Day 28 of Community Screening Campaign 1 (CSC1) in Infants and Children (>6 Months and <5 Years)- Cluster Data
NCT01256658 (22) [back to overview]Microscopy Confirmed Asymptomatic Carriers of P. Falciparum at Community Screening Campaign 4 (CSC4) (Per Cluster)
NCT01256658 (22) [back to overview]Microscopy-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4) (Per Cluster)
NCT01256658 (22) [back to overview]Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Community Screening Campaign 1 (CSC1) Infants and Children (>6 Months and <5 Years)- Individual Data
NCT01256658 (22) [back to overview]Anemia Status Based on Community Screening Campaign 1 (CSC1)/Day 1 in Infants and Children (>6 Months and <5 Years)
NCT01256658 (22) [back to overview]Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Infants and Children (<5 Years) in Post Community Screening Campaign (CSC) at Month 12 (Per Cluster)
NCT01256658 (22) [back to overview]Anemia Status Based on Community Screening Campaign 4 (CSC4)/Day 1 in Infants and Children (>6 Months and <5 Years)
NCT01256658 (22) [back to overview]Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1 (CSC1)/Day 1 to CSC1/Day 28 in Infants and Children (>6 Months and <5 Years) for Asymptomatic Carriers at CSC1
NCT01256658 (22) [back to overview]Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1(CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 (Per Cluster)
NCT01256658 (22) [back to overview]Change in Hemoglobin Level (g/dL) in Asymptomatic Carriers >6 Months of Age (Per Cluster)
NCT01256658 (22) [back to overview]Cumulative Number of Subjects With Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL From Week 1 to Week 50
NCT01256658 (22) [back to overview]Hemoglobin Level (g/dL) in Community Screening Campaign 1 (CSC1)/Day 1 and CSC4/Day 1 by Study Arm and Age Group (Per Cluster)
NCT01256658 (22) [back to overview]Mean Number of Microscopy-confirmed Gametocyte Carriers at Day 1 of Community Screening Campaign 1,2,3,4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)
NCT01256658 (22) [back to overview]Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Post Community Screening Campaign (CSC)
NCT01256658 (22) [back to overview]Mean of Microscopy-confirmed Asymptomatic Carriers From Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)
NCT01256658 (22) [back to overview]Number of Asymptomatic Carriers With Complicated and Uncomplicated Episodes Combined
NCT01256658 (22) [back to overview]Number of Microscopy and qRT-PCR-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4)
NCT01256658 (22) [back to overview]Number of Participants (Infants and Children (> 6 Months and < 5 Years)) With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)
NCT01256658 (22) [back to overview]Number of Participants With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)
NCT01256658 (22) [back to overview]Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000) in Asymptomatic Carriers at Any Time of Diagnosis (Per Cluster)
NCT01256658 (22) [back to overview]Percentage of COA566-treated Microscopy-confirmed Asymptomatic Carriers at Community Screening Campaign 1, 2 and 3 (CSC1, CSC2 and CSC3) With Parasitological Cure Rate at Day 7
NCT01256658 (22) [back to overview]Percentage of Microscopy-confirmed Gametocyte Carriers Treated With COA566 for Asymptomatic Carriers
NCT01619878 (9) [back to overview]Time to Parasite Clearance (PCT)
NCT01619878 (9) [back to overview]Time to Gametocyte Clearance (GCT)
NCT01619878 (9) [back to overview]Time to Fever Clearance (FCT)
NCT01619878 (9) [back to overview]Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate
NCT01619878 (9) [back to overview]Percent Change of Parasite Count From Baseline at 24 Hours
NCT01619878 (9) [back to overview]Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline
NCT01619878 (9) [back to overview]Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline
NCT01619878 (9) [back to overview]Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42
NCT01619878 (9) [back to overview]Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42
NCT02223871 (9) [back to overview]Drug-specific Parasite Reduction Ratio (PRR48) of ACT-451840 Over 48 Hours Using a New Approach
NCT02223871 (9) [back to overview]Drug-specific Parasite Reduction Ratio (PRR48) of ACT-451840 Over 48 Hours Using a Standardized Approach
NCT02223871 (9) [back to overview]Maximum Plasma Concentration (Cmax) of ACT-451840
NCT02223871 (9) [back to overview]Terminal Half-life [t(1/2)]
NCT02223871 (9) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) of ACT-451840
NCT02223871 (9) [back to overview]Areas Under the Plasma Concentration-time Curve of ACT-451840
NCT02223871 (9) [back to overview]Change From Baseline in Blood Pressure to End of Study (EOS)
NCT02223871 (9) [back to overview]Change From Baseline in Body Temperature up to End of Study (EOS)
NCT02223871 (9) [back to overview]Change From Baseline in Respiratory Rate to End of Study (EOS)
NCT02389374 (9) [back to overview]Proportion of Patients With Fever on Day 2 After Treatment
NCT02389374 (9) [back to overview]Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count
NCT02389374 (9) [back to overview]Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl)
NCT02389374 (9) [back to overview]Proportion of Patients With Anaemia Less Than 8g/dl on Day 2
NCT02389374 (9) [back to overview]Proportion of Patients With Any Parasitemia on Day 3 After Treatment
NCT02389374 (9) [back to overview]Fractional Change in Hb Between Baseline and Day 9 and 16
NCT02389374 (9) [back to overview]Recurrence of Parasitaemia Within 16 Days of Follow up
NCT02389374 (9) [back to overview]The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients
NCT02389374 (9) [back to overview]The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment
NCT02600767 (1) [back to overview]Absence of Malaria Parasites in Blood.
NCT03167242 (13) [back to overview]PK Run-in: Area Under the Blood Concentration-time Curve Over the Last 24 Hours After Treatment Dose (AUC0-24h) of KAF156
NCT03167242 (13) [back to overview]PK Run-in, Part A and Part B: Parasite Clearance Time (PCT)
NCT03167242 (13) [back to overview]Part A and Part B: Area Under the Blood Concentration-time Curve Over the Last 24 Hours After Last Treatment Dose (AUC0-24h) of KAF156
NCT03167242 (13) [back to overview]PK Run-in and Part A: Elimination Half-life (T½) of KAF156
NCT03167242 (13) [back to overview]Part A and Part B: Number of Participants With Reinfection Events
NCT03167242 (13) [back to overview]Part A and Part B: Number of Participants With Recrudescence Events
NCT03167242 (13) [back to overview]Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29
NCT03167242 (13) [back to overview]Part A and Part B: Maximum Peak Observed Concentration (Cmax) of KAF156
NCT03167242 (13) [back to overview]PK Run-in and Part A (Cohorts 1 and 2): Time to Reach Maximum Blood Concentrations (Tmax) of KAF156
NCT03167242 (13) [back to overview]Part A and Part B: Fever Clearance Time (FCT)
NCT03167242 (13) [back to overview]PK Run-in, Part A and Part B: Number of Participants With Parasitaemia
NCT03167242 (13) [back to overview]Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Uncorrected Adequate Clinical and Parasitological Response (ACPR)
NCT03167242 (13) [back to overview]Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR)
NCT03334747 (14) [back to overview]Tmax
NCT03334747 (14) [back to overview]Tmax
NCT03334747 (14) [back to overview]Time to Recrudescence and Reinfection at Study Day 29
NCT03334747 (14) [back to overview]Time to Recrudescence and Reinfection at Study Day 29
NCT03334747 (14) [back to overview]Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected and Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 15 and Day 29
NCT03334747 (14) [back to overview]Maximum Peak Observed Concentration (Cmax)
NCT03334747 (14) [back to overview]Maximum Peak Observed Concentration (Cmax)
NCT03334747 (14) [back to overview]Half-life (T^1/2)
NCT03334747 (14) [back to overview]Parasite Clearance Time (PCT)
NCT03334747 (14) [back to overview]Number of Participants With at Least 2 CTCAE Grades Increase From Baseline in Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)
NCT03334747 (14) [back to overview]Half-life (T^1/2)
NCT03334747 (14) [back to overview]Fever Clearance Time (FCT)
NCT03334747 (14) [back to overview]AUC0-24
NCT03334747 (14) [back to overview]AUC0-24
NCT03510481 (2) [back to overview]Number of Participants With Local and Systemic Adverse Events in Year One
NCT03510481 (2) [back to overview]Number of Participants With Local and Systemic Adverse Events in Year Two
NCT03813108 (5) [back to overview]Break Through Infections
NCT03813108 (5) [back to overview]Magnitude of Adverse Events After NF135.C10 CPS Immunization
NCT03813108 (5) [back to overview]Break Through Infections
NCT03813108 (5) [back to overview]Frequency of Adverse Events After NF135.C10 CPS Immunization
NCT03813108 (5) [back to overview]Time to Parasitemia
NCT04222088 (4) [back to overview]Adequate Clinical and Parasitological Response (ACPR)
NCT04222088 (4) [back to overview]Late Parasitological Failure (LPF)
NCT04222088 (4) [back to overview]Late Clinical Failure (LCF)
NCT04222088 (4) [back to overview]Early Treatment Failure (ETF)
NCT04310085 (9) [back to overview]Parasitaemia at First Dose of Treatment With Riamet® (Cohorts 1 and 2)
NCT04310085 (9) [back to overview]Incidence of Positive PCR and Parasitaemia of ≥5000 Parasites Per mL Blood.
NCT04310085 (9) [back to overview]Time to First Dose of Treatment With Artemether-lumefantrine (Riamet®) (Cohorts 1 and 2)
NCT04310085 (9) [back to overview]Time to First PCR Positivity.
NCT04310085 (9) [back to overview]Parasitaemia at the Time Parasitaemia ≥5000 Parasites Per mL Blood (Cohorts 1 and 2)
NCT04310085 (9) [back to overview]Change in Malaria Clinical Score From PfSPZ-DVI Challenge Until Parasite Clearance.
NCT04310085 (9) [back to overview]Time to Parasitaemia of ≥5000 Parasites Per mL Blood (Cohorts 1 and 2)
NCT04310085 (9) [back to overview]Incidence and Severity of Observed or Self-reported Adverse Events (AEs) Considered PfSPZ-DVI Challenge Inoculum-related.
NCT04310085 (9) [back to overview]Parasitaemia at First PCR Positivity
NCT04456634 (5) [back to overview]AUECt of pSTAT3 Inhibition
NCT04456634 (5) [back to overview]Number of Participants With Changes in Heart Rate
NCT04456634 (5) [back to overview]Number of Participants With Changes of Systolic and Diastolic Blood Pressure
NCT04456634 (5) [back to overview]Number of Participants With ECG Changes
NCT04456634 (5) [back to overview]Number of Participant With Treatment-Related Adverse Events as Assessed by CTCAE V4.03, All of Observed and Self-reported AEs Affected, by Treatment Regimen.

Cure Rate on Day 28

To evaluate the safety and antimalarial efficacy of two drug combinations: Artemether-Lumefantrine (AL) and Amodiaquine-Artesunate (AQ - AS) in Camaroonian patients in Mutengene, Bangolan and Garoua (NCT00297882)
Timeframe: Day 0 - 28

InterventionParticipants (Count of Participants)
1 Artemether-Lumefantrine AL197
2 Amodiaquine-Artesunate AQ-AS603

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Cure Rate Day 14

To evaluate antimalarial efficacy of AL and AQ-AS on day 14 post-treatment (NCT00297882)
Timeframe: Day 0-14

InterventionParticipants (Count of Participants)
1 Artemether-Lumefantrine192
2 Amodiaquine-Artesunate563

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Proportion of Patients With Parasite Clearance at Day 1, 2 and 3

Parasite clearance time is defined as the time from first dosing to the time of first blood draw with parasite clearance. Parasite clearance was defined as zero presence of asexual parasites for 2 consecutive negative readings taken between 7 and 25 hours apart. (NCT00422084)
Timeframe: Days 1, 2, 3

,
Interventionpercentage of subjects (Number)
Clearance rate (%) at Day 1 (24h after first dose)Clearance rate (%) at Day 2 (48h after first dose)Clearance rate (%) at Day 3 (72h after first dose)
AL Group52.897.299.7
PA Group68.198.199.5

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Percentage of Patients With Fever Clearance at Day 1, 2 and 3

Fever clearance time is defined as the time from first dosing to first normal reading of temperature for 2 consecutive normal temperature readings taken between 7 and 25 hours apart. (NCT00422084)
Timeframe: Days 1, 2, 3

,
Interventionpercentage of subjects (Number)
Clearance rate (%) at Day 1 (24h after first dose)Clearance rate (%) at Day 2 (48h after first dose)Clearance rate (%) at Day 3 (72h after first dose)
AL Group87.098.799.3
PA Group88.799.099.5

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Crude ACPR (Non-PCR Corrected ACPR) on Day 14 and Day 28

Percentage of subjects with adequate clinical and parasitological response (ACPR) on Day 28, without correction by PCR, defined as absence of parasitaemia on Day 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure. (NCT00422084)
Timeframe: Day 14 and 28

,
Interventionpercentage of subjects (Number)
Cure rate (%) at Day 14Cure rate (%) at Day 28
AL Group10097.2
PA Group10098.9

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Adverse Events and Clinically Significant Laboratory Results

Incidence of adverse events and of clinically significant laboratory results, ECG, vital signs or physical examination abnormalities. (NCT00422084)
Timeframe: Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier

,
InterventionParticipants (Count of Participants)
Nr subj. with ≥1 AENr subj. with ≥1 treatment-related AENr subj. with ≥1 SAENr pat with ≥1 treatment-related SAENr subj. with ≥1 severe or life-threatening AENr subj. with ≥1 AE leading to deathNr subj. ≥1 AE leading to drug discontinuationNr subj. with ≥1 AE leading to study withdrawal
AL Group241123205056
PA Group509275301001619

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PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28

Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28, defined as absence of parasitaemia on Day 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure. (NCT00422084)
Timeframe: Day 28

Interventionpercentage of subjects (Number)
PA Group99.5
AL Group99.2

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PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 14

Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 14, defined as absence of parasitaemia on Day 14 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure. (NCT00422084)
Timeframe: Day 14

Interventionpercentage of subjects (Number)
PA Group99.9
AL Group100

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Parasite Clearance Time

Parasite clearance time is defined as the time from first dosing to the time of first blood draw with parasite clearance. Parasite clearance is defined as zero presence of asexual parasites for 2 consecutive negative readings taken between 7 and 25 hours apart. (NCT00422084)
Timeframe: Days 0, 3, 7, 14, 21, 28, 35, and 42 (or on any other day if the subject spontaneously returned)

Interventionhours (Median)
PA Group23.9
AL Group24.0

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Fever Clearance Time

Fever clearance time is defined as the time from first dosing to first normal reading of temperature for 2 consecutive normal temperature readings taken between 7 and 25 hours apart (NCT00422084)
Timeframe: Day 0 and every 8 hours over ≥72 hours following first study drug administration or temperature normalization for ≥2 readings between 7 and 25 hours apart, then at each visit and as clinically indicated

Interventionhours (Median)
PA Group7.9
AL Group8.0

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Relationship Between Changes in Auditory Function and Treatment Groups

ABR Wave III latency (ms) changes from baseline to Day 7 in the three drug exposure groups. (NCT00444106)
Timeframe: From Baseline to Day 7

,,
Interventionms (Mean)
Baseline Right EarChange from baseline to Day 7 Right EarBaseline Left EarChange from baseline to Day 7 Left Ear
Artemether-lumefantrine (Coartem)3.860.013.850.01
Artesunate-mefloquine3.86-0.043.82-0.03
Atovaquone-proguanil (Malarone)3.89-0.013.88-0.01

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Efficacy of Polymerase Chain Reaction (PCR) Adjusted Malaria Cure Rates of the Three Treatment Regimens at Days 14, 28 and 42

Percentage of patients with clearance of asexual parasitemia (observed by optical microscopy) within 7 days of initiation of trial treatment without recrudescence within 14, 28 and 42 days respectively after initiation of treatment. Patients with recurrent parasitemia and paired PCR results were classified as either a new infection (different paired genotypes) or a recrudescence (matching paired genotypes). Patients without paired PCR results or ambiguous results were classified as treatment failures. (NCT00444106)
Timeframe: Days 14, 28 and 42

,,
InterventionPercentage of Participants (Number)
Day 14Day 28Day 42
Artemether-lumefantrine (Coartem)99.498.797.5
Artesunate-mefloquine98.198.198.1
Atovaquone-proguanil (Malarone)100.098.198.1

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Auditory Changes Following 3 Days of Treatment at Days 3, 7, 28, and 42 Days as Assessed by Pure Tone Thresholds Assessments (a Type of Hearing Test)

Audiometric measurements such as pure-tone threshold (air conduction tested at 250 to 8000 HZ) day 3, 7, 28 and 42 following initiation of treatment, including changes from baseline. Pure-tone average (PTA) calculated for each ear by averaging the pure-tone threshold values at 500, 1000, 2000 and 3000 HZ. (NCT00444106)
Timeframe: Baseline (Day 1), 3, 7, 28 and Day 42

,,
InterventiondB (Mean)
Baseline Right EarChange from baseline to Day 3 Right EarChange from baseline to Day 7 Right EarChange from baseline to Day 28 Right EarChange from baseline to Day 42 Right EarBaseline Left EarChange from baseline to Day 3 Left EarChange from baseline to Day 7 Left EarChange from baseline to Day 28 Left EarChange from baseline to Day 42 Left Ear
Artemether-lumefantrine12.2-2.5-2.2-2.7-3.011.4-1.2-1.7-2.0-1.5
Artesunate-mefloquine12.7-1.9-2.6-3.6-3.112.5-1.2-1.4-2.5-3.0
Atovaquone-proguanil (Malarone)12.0-2.4-2.6-2.6-3.311.3-1.5-1.3-1.8-2.1

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Percentage of Participants With Auditory Abnormalities at Day 7 Assessed by Auditory Brainstem Response (ABR) Wave III Latency Changes on Day 7(a Type of Hearing Test)

"To demonstrate the safety of artemether-lumefantrine after 3 days of treatment in patients with acute, uncomplicated falciparum malaria by testing the null hypothesis that the rate of auditory abnormalities is ≥ 15% in the population treated with artemether-lumefantrine as assessed by ABR at Day 7 following initiation of treatment compared with their baseline values. An auditory nerve abnormality is here defined as a greater than 0.30 ms change in Wave III latency from baseline to Day 7. Exact Pearson-Clopper two-sided 95% confidence limits were constructed for all three treatment groups." (NCT00444106)
Timeframe: 7 days

InterventionPercentage of Participants (Number)
Artemether-lumefantrine (Coartem)2.6

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Percentage of Participants With PCR-Corrected ACPR on Day 28

Percentage of patients with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28. The PCR-corrected ACPR on Day 28 is defined as the absence of parasitaemia on Day 28 without the patient's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure (NCT00541385)
Timeframe: Day 28

Interventionpercentage of cured subjects (Number)
PA Group97.6
AL Group98.8

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Percentage of Participants With PCR-Corrected ACPR on Day 14

Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 14. The PCR-corrected ACPR on Day 14 is defined as the absence of parasitaemia on Day 14 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure (NCT00541385)
Timeframe: Day 14

Interventionpercentage of subjects (Number)
PA Group100.0
AL Group100.0

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Parasite Clearance Time

Parasite clearance time is defined as the time from first dosing to the time of first blood draw with parasite clearance. Parasite clearance was defined as zero presence of asexual parasites for 2 consecutive negative readings taken between 7 and 25 hours apart (NCT00541385)
Timeframe: Days 0, 3, 7, 14, 21, 28, 35, and 42 or on any other day if the subject spontaneously returned within the 42-day study period

Interventionhours (Median)
PA Group24.1
AL Group24.2

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Fever Clearance Time

Fever clearance time is defined as the time from first dosing to the first normal reading of temperature for 2 consecutive normal temperature readings taken between 7 and 25 hours apart. (NCT00541385)
Timeframe: Day 0 and every 8 hours over ≥72 hours following first study drug administration or temperature normalization for ≥2 readings between 7 and 25 hours apart, then at each visit and as clinically indicated (within the 42-day study period)

Interventionhours (Median)
PA Group8.1
AL Group8.1

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Proportion of Subjects With Fever Cleared on Days 1, 2, and 3

Fever clearance time is defined as the time from first dosing to the first normal reading of temperature for 2 consecutive normal temperature readings taken between 7 and 25 hours apart (NCT00541385)
Timeframe: Days 1, 2, and 3

,
Interventionpercentage of subjects (Number)
Percentage of Participants with fever clearance at Day 1 (24h after first dose)Percentage of Participants with fever clearance at Day 2 (48h after first dose)Percentage of Participants with fever clearance at Day 3 (48h after first dose)
AL Group81.096.898.4
PA Group87.198.599.6

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Number of Subjects With ≥1 Adverse Event

(NCT00541385)
Timeframe: Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier

,
InterventionParticipants (Count of Participants)
Nr subj. with ≥1 AENr subj. with ≥1 treatment-related AENr subj. with ≥1 SAENr subj. with ≥1 treatment-related SAENr subj. with ≥1 severe or life-threatening AENr subj. with ≥1 AE leading to deathNr subj. ≥1 AE leading to drug discontinuationNr subj. with ≥1 AE leading to study withdrawal
AL Group14380002033
PA Group285132102066

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Proportion of Subjects With Cleared Parasites on Days 1, 2, and 3

Parasite clearance time is defined as the time from first dosing to the time of first blood draw with parasite clearance. Parasite clearance was defined as zero presence of asexual parasites for 2 consecutive negative readings taken between 7 and 25 hours apart (NCT00541385)
Timeframe: Days 1, 2, and 3

,
Interventionpercentage of subjects (Number)
Percentage of Participants with parasite clearance at Day 1 (24h after first dose)Percentage of Participants with parasite clearance at Day 2 (48h after first dose)Percentage of Participants with parasite clearance at Day 3 (72h after first dose)
AL Group43.795.298.8
PA Group49.995.597.0

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Crude ACPR (Non-PCR Corrected ACPR) (Crude Cure Rate) on Day 14 and Day 28

Percentage of subjects with adequate clinical and parasitological response (ACPR) on Day 14 and 28, without correction by PCR. Crude ACPR on Day 14 and 28 is defined as the absence of parasitaemia on Day 14 and 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure (NCT00541385)
Timeframe: Days 14 and 28

,
Interventionpercentage of subjects (Number)
Percentage of Participants with ACPR at Day 14Percentage of Participants with ACPR at Day 28
AL Group10089.2
PA Group10090.2

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Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population

ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. (NCT00677833)
Timeframe: Day 28

InterventionPercentage of participants (Number)
Cohort 2: Azithromycin + Chloroquine93.08
Cohort 2: Artemether + Lumefantrine99.16

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Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population

ACPR (PCR-corrected) was defined as asexual Plasmodium falciparum (P.falciparum) parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of Early Treatment Failure (ETF) (see measure description in secondary outcome measures 7 and 8) or PCR-corrected Late Treatment Failure (LTF) (which includes PCR-corrected Late Clinical Failures [LCF] - see measure description in secondary outcome measure 9 and 10, and PCR-corrected Late Parasitologic Failures (LPF)- see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. (NCT00677833)
Timeframe: Day 28

InterventionPercentage of participants (Number)
Cohort 2: Azithromycin + Chloroquine89.27
Cohort 2: Artemether + Lumefantrine98.37

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Time to Recurrence of Parasitemia

Time from the day of clearance to the time of recurrence of asexual P.falciparum parasitemia (PCR-uncorrected). (NCT00677833)
Timeframe: Baseline (Day 0) to Day 42

InterventionDays (Median)
Cohort 2: Azithromycin + Chloroquine34
Cohort 2: Artemether + LumefantrineNA

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Change From Nadir Hemoglobin Level at Days 14, 28, and 42

Change from nadir = observation minus nadir. Nadir defined as the minimum value for each participant on Days 0-3. (NCT00677833)
Timeframe: Day 14, 28, 42

,
Interventiong/dL (Mean)
Change at Day 14 (n=122, 127)Change at Day 28 (n=122, 127)Change at Day 42 (n=122, 128)
Cohort 2: Artemether + Lumefantrine0.440.961.14
Cohort 2: Azithromycin + Chloroquine0.521.151.29

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Percentage of Participants With Gametocytologic Response

Gametocyte response/absence/clearance: Clearance of P.falciparum gametocytemia (PCR-uncorrected) (attainment of 2 consecutive zero gametocyte counts) without subsequent recurrence through the day of consideration. PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection. (NCT00677833)
Timeframe: Days 7, 14, 21, 28, 35, 42

,
InterventionPercentage of participants (Number)
Day 7 (n=122, 129)Day 14 (n=122, 130)Day 21 (n=122, 130)Day 28 (n=122, 130)Day 35 (n=122, 130)Day 42 (n=122, 130)
Cohort 2: Artemether + Lumefantrine91.4791.5493.0893.0892.3191.54
Cohort 2: Azithromycin + Chloroquine81.9781.1580.3381.9781.9780.33

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Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected)

"LCF included participants who met any of the following criteria:~Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8)~Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation." (NCT00677833)
Timeframe: Days 7, 14, 21, 28, 35, 42

,
InterventionPercentage of participants (Number)
Day 7Day 14Day 21Day 28Day 35Day 42
Cohort 2: Artemether + Lumefantrine000000
Cohort 2: Azithromycin + Chloroquine000000

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Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected)

LPF: Presence of P. falciparum parasitemia in the mITT population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. (NCT00677833)
Timeframe: Days 7, 14, 21, 28, 35, 42

,
InterventionPercentage of participants (Number)
Day 7Day 14Day 21Day 28Day 35Day 42
Cohort 2: Artemether + Lumefantrine000.790.792.382.38
Cohort 2: Azithromycin + Chloroquine01.672.504.174.175.00

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Percentage of Participants With LCF in PP Population (PCR-corrected)

"LCF included participants who met any of the following criteria:~Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8)~Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation." (NCT00677833)
Timeframe: Days 7, 14, 21, 28, 35, 42

,
InterventionPercentage of participants (Number)
Day 7Day 14Day 21Day 28Day 35Day 42
Cohort 2: Artemether + Lumefantrine000000
Cohort 2: Azithromycin + Chloroquine000000

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Fever Clearance Time

Calculated as time of first occurrence of two consecutive time points with temperature less than (<) 38.0 degrees C/100.4 degrees Fahrenheit (F) (rectal), 37.2 degrees C/99.0 degrees F (axillary), or <37.5 degrees C/99.5 degrees F (oral). (NCT00677833)
Timeframe: Baseline to Day 42

InterventionHours (Median)
Cohort 2: Azithromycin + Chloroquine24.000
Cohort 2: Artemether + Lumefantrine24.000

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Percentage of Participants With LPF in PP Population (PCR-corrected)

LPF: Presence of P.falciparum parasitemia in the PP population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. (NCT00677833)
Timeframe: Days 7, 14, 21, 28, 35, 42

,
InterventionPercentage of participants (Number)
Day 7Day 14Day 21Day 28Day 35Day 42
Cohort 2: Artemether + Lumefantrine000.810.812.422.42
Cohort 2: Azithromycin + Chloroquine01.752.634.394.395.26

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Percentage of Participants With PCR-uncorrected ACPR in the mITT Population

ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection. (NCT00677833)
Timeframe: Days 7, 14, 21, 28, 35, 42

,
InterventionPercentage of participants (Number)
Day 7Day 14Day 21Day 28Day 35Day 42
Cohort 2: Artemether + Lumefantrine99.2196.7982.9673.3162.9156.29
Cohort 2: Azithromycin + Chloroquine94.1789.0867.8751.5544.6737.80

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Percentage of Participants With PCR-corrected ACPR in PP Population

ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. (NCT00677833)
Timeframe: Days 7, 14, 21, 35, 42

,
InterventionPercentage of participants (Number)
Day 7Day 14Day 21Day 35Day 42
Cohort 2: Artemether + Lumefantrine100.00100.0099.1696.9696.96
Cohort 2: Azithromycin + Chloroquine98.2596.4695.5393.0891.29

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Percentage of Participants With PCR-corrected ACPR in the mITT Population

ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-Corrected LCF- see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. (NCT00677833)
Timeframe: Days 7, 14, 21, 35, 42

,
InterventionPercentage of participants (Number)
Day 7Day 14Day 21Day 35Day 42
Cohort 2: Artemether + Lumefantrine99.2199.2198.3796.1996.19
Cohort 2: Azithromycin + Chloroquine94.1792.4791.5989.2787.55

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Percentage of Participants With PCR-uncorrected ACPR in PP Population

ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection. (NCT00677833)
Timeframe: Days 7, 14, 21, 28, 35, 42

,
InterventionPercentage of participants (Number)
Day 7Day 14Day 21Day 28Day 35Day 42
Cohort 2: Artemether + Lumefantrine100.0097.5683.6273.9063.4156.74
Cohort 2: Azithromycin + Chloroquine98.2592.8970.5654.2847.0439.80

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Percentage of Participants With Asexual Parasitologic Response (PCR-corrected)

Percentage of participants who were cleared of asexual parasites. Asexual parasite clearance - clearance of asexual P.falciparum parasitemia within 7 days of initiation of treatment without subsequent recurrence (PCR-corrected) through the day of consideration. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. (NCT00677833)
Timeframe: Day 7, 14, 21, 28, 35, 42

,
InterventionPercentage of participants (Number)
Day 7 (n=120, 128)Day 14 (n=120, 127)Day 21 (n=120, 128)Day 28 (n=120, 127)Day 35 (n=120, 128)Day 42 (n=120, 127)
Cohort 2: Artemether + Lumefantrine99.2299.2198.4498.4396.8896.85
Cohort 2: Azithromycin + Chloroquine93.3391.6790.8389.1789.1788.33

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Asexual Plasmodium Falciparum Parasite Clearance Time

Defined as time to first of two consecutive zero asexual P. falciparum parasite (PCR-corrected) counts, regardless of recurrence of parasitemia later. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. (NCT00677833)
Timeframe: Baseline to Day 42

InterventionHours (Median)
Cohort 2: Azithromycin + Chloroquine48.000
Cohort 2: Artemether + Lumefantrine24.000

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Nadir Hemoglobin Level

Nadir hemoglobin for each participant was defined as the minimum hemoglobin values obtained from Day 0 through Day 3. (NCT00677833)
Timeframe: Day 0 through Day 3

Interventiongrams per deciliter (g/dL) (Mean)
Cohort 2: Azithromycin + Chloroquine9.63
Cohort 2: Artemether + Lumefantrine9.82

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Percentage of Participants With Early Treatment Failure (ETF) in the mITT Population (PCR-corrected)

"ETF defined as participants who met the following criteria:~Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P. falciparum parasitemia~Last available asexual P. falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature.~Parasitemia (P. falciparum) on Day 3 with fever or~Last available P. falciparum parasite count on Day 3 >=25% of the first available parasite count on Day 0 (Baseline).~PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation." (NCT00677833)
Timeframe: Day 0 up to Day 3

InterventionPercentage of participants (Number)
Cohort 2: Azithromycin + Chloroquine5.83
Cohort 2: Artemether + Lumefantrine0.79

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Percentage of Participants With ETF in PP Population (PCR-corrected)

"ETF defined as participants who met the following criteria:~Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P.falciparum parasitemia~Last available asexual P.falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature.~Parasitemia (P.falciparum) on Day 3 with fever or~Last available P.falciparum parasite count on Day 3 >=25% of the first available parasite count on Day 0 (Baseline).~PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation." (NCT00677833)
Timeframe: Day 0 up to Day 3

InterventionPercentage of participants (Number)
Cohort 2: Azithromycin + Chloroquine1.75
Cohort 2: Artemether + Lumefantrine0

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Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Day 1 to Day 28 of Community Screening Campaign 1 (CSC1) in Infants and Children (>6 Months and <5 Years)- Cluster Data

"Data is presented per cluster. Cluster data of number of asymptomatic carriers with increase in hemoglobin levels by at least 0.5 g/dL from Day 1 to Day 28 of Community Screening Campaign 1 (CSC1) in infants and children (>6 months and <5 years) was measured by Hemoglobin levels based on microscopy reading.~Mean and Standard Deviation (SD) percent were measured indicating the mean and SD of percentages of cluster frequencies under the study arm for that particular category." (NCT01256658)
Timeframe: Day 1 to day 28 - period 1

Interventionparticipants (Mean)
Intervention66.1
Control43.2

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Microscopy Confirmed Asymptomatic Carriers of P. Falciparum at Community Screening Campaign 4 (CSC4) (Per Cluster)

"Data is presented per cluster. Microscopy confirmation of asymptomatic carriers of P. falciparum at Community Screening Campaign 4 (CSC4) was conducted at month 12. Blood films were histologically treated and examined microscopically. When it was ascertained that P. falciparum was present, a count of the asexual forms against leukocytes was made using a tally counter." (NCT01256658)
Timeframe: Month 12 - period 1

Interventionparticipants (Mean)
Intervention34.6
Control37.6

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Microscopy-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4) (Per Cluster)

"Data is presented per cluster. Microscopy confirmed gametocyte carriers at Community Screening Campaign 4(CSC4) were assessed via microscopy at month 12 of period 1. Blood films were histologically treated and examined microscopically." (NCT01256658)
Timeframe: Month 12 - period 1

Interventionparticipants (Mean)
Intervention4.9
Control5.1

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Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Community Screening Campaign 1 (CSC1) Infants and Children (>6 Months and <5 Years)- Individual Data

Individual data of number of asymptomatic carriers with increase in hemoglobin levels by at least 0.5 g/dL from Day 1 to Day 28 from Community Screening Campaign 1 (CSC1) infants and children (>6 months and <5 years). Hemoglobin levels were measured using the HemoCue® rapid test. This test was performed with a drop of blood collected from the fingertip at Day 1 and at Day 28. (NCT01256658)
Timeframe: Day 1 to Day 28- period 1

Interventionparticipants (Number)
Intervention288
Control79

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Anemia Status Based on Community Screening Campaign 1 (CSC1)/Day 1 in Infants and Children (>6 Months and <5 Years)

Anemia status based on Community Screening Campaign 1 (CSC1)/Day 1 in infants and children (>6 months and <5 years) was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) <5 g/dL = severe anemia, Hb 5 to <8 g/dL = moderate anemia, Hb 8 to <11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia). (NCT01256658)
Timeframe: Day 1 (CSC1/day 1) - period 1

,
Interventionparticipants (Number)
CSC1/Day 1 SevereCSC1/Day 1 ModerateCSC1/Day 1 MildCSC1/Day 1 No symptoms
Control136195116
Intervention380458278

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Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Infants and Children (<5 Years) in Post Community Screening Campaign (CSC) at Month 12 (Per Cluster)

"Data is presented per cluster. Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000s) per person-year in infants and children (<5 years) in post Community Screening Campaign (CSC) at month 12 was detected by Rapid Diagnostic Test (RDT) (using a blood sample from each participant) and later confirmed to have a parasite density ≥5000/uL by microscopy.~Number of SMRC5000: sum of all SMRC5000 for all infants and children (<5 years) in post CSC.~Person-year observed: sum of duration (in days) for all infants and children (<5 years) in post CSC present in study /365.25.~Number of SMRC5000 per person-year = number of SMRC5000/person-year observed." (NCT01256658)
Timeframe: Month 12 of period 1

InterventionSMRC5000 per person-year (Mean)
Intervention1.69
Control1.60

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Anemia Status Based on Community Screening Campaign 4 (CSC4)/Day 1 in Infants and Children (>6 Months and <5 Years)

Anemia status based on Community Screening Campaign 4 (CSC4/Day 1) in infants and children (>6 months and <5 years) was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) <5 g/dL = severe anemia, Hb 5 to <8 g/dL = moderate anemia, Hb 8 to <11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia). (NCT01256658)
Timeframe: Month 12 (CSC4/day 1) - period 1

,
Interventionparticipants (Number)
CSC4/Day 1 SevereCSC4/Day 1 ModerateCSC4/Day 1 MildCSC4/Day 1 No
Control19117194
Intervention129349448

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Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1 (CSC1)/Day 1 to CSC1/Day 28 in Infants and Children (>6 Months and <5 Years) for Asymptomatic Carriers at CSC1

Change in hemoglobin level (g/dL) from Community Screening Campaign 1 (CSC1)/Day 1 to CSC1/Day 28 in infants and children (>6 Months and <5 Years) for asymptomatic carriers at CSC1 was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) <5 g/dL = severe anemia, Hb 5 to <8 g/dL = moderate anemia, Hb 8 to <11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia). (NCT01256658)
Timeframe: Day 1 and day 28 - period 1

,
Interventiong/dL (Mean)
CSC1/Day 1 (n=432 ; 179 )CSC1/Day 28 (n=406 ; 174 )
Control9.6710.17
Intervention9.7810.95

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Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1(CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 (Per Cluster)

"Data is presented per cluster. Comparison of hemoglobin level (g/dL) from Community Screening Campaign 1 (CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 in infants and children (>6 months and <5 years) by study arm was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant." (NCT01256658)
Timeframe: Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1

,
Interventiong/dL (Mean)
CSC1/Day 1 (n= 819, 827)CSC4/Day 1 (n= 348,321)
Control10.0411.13
Intervention10.2410.99

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Change in Hemoglobin Level (g/dL) in Asymptomatic Carriers >6 Months of Age (Per Cluster)

"Data is presented per cluster. Change in hemoglobin levels from day 1 to day 28 was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each asymptomatic carrier from Community Screening Campaign 1 (CSC1), > 6 months of age, at day 1 and at day 28." (NCT01256658)
Timeframe: Day 1 and day 28 of period 1

,
Interventiong/dL (Mean)
Day 1 (n = 2387, 2116)Day 28 (n = 1136, 1091)
Control12.0611.86
Intervention11.8112.33

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Cumulative Number of Subjects With Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL From Week 1 to Week 50

"Cumulative number of asymptomatic carriers having Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) from Week 1 to Week 50, was measured from group of participants diagnosed as asymptomatic carriers at Community Screening Campaign (CSC1)/Day1. Number of participants affected before and after diagnosed with ≥1 symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) (complicated and uncomplicated episodes combined). Number of SMRC5000s was detected by Rapid Diagnostic Test (RDT) using a blood sample from each participant and later confirmed to have a parasite density > or = 5000/uL by microscopy.~Week (1-2) indicates day1 to day14, week (3-4) indicates day 15 to day 28, week (5-6) indicates day 29 to day 42, etc. After first diagnosis of asymptomatic carriers at CSC1/Day1." (NCT01256658)
Timeframe: Week 1 to Week 50

,
Interventionparticipants (Number)
Week (1-2) n at risk= 2397, 1138Week (3-4) n at risk= 2396, 1133Week (5-6) n at risk= 2391, 1129Week (7-8) n at risk= 2390, 1124Week (9-10) n at risk= 2390, 1123Week (11-12) n at risk= 2390, 1121Week (13-14) n at risk= 2390, 1103Week (15-16) n at risk= 2390, 1102Week (17-18) n at risk= 2390, 1102Week (19-20) n at risk= 2390, 1102Week (21-22) n at risk= 2337, 1083Week (23-24) n at risk= 2311, 1077Week (25-26) n at risk= 2246, 1063Week (27-28) n at risk= 2148, 1041Week (29-30) n at risk= 2047, 1020Week (31-32) n at risk= 1979, 996Week (33-34) n at risk= 1931, 979Week (35-36) n at risk= 1894, 968Week (37-38) n at risk= 1868, 956Week (39-40) n at risk= 1837, 935Week (41-42) n at risk= 1816, 927Week (43-44) n at risk= 1805, 920Week (45-46) n at risk= 1785, 913Week (47-48) n at risk= 1773, 910Week (49-50) n at risk= 1758, 904
Control4812131517181818202438597998114121130144149154158159161161
Intervention13444444473092188287347391421440460477483486490492493

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Hemoglobin Level (g/dL) in Community Screening Campaign 1 (CSC1)/Day 1 and CSC4/Day 1 by Study Arm and Age Group (Per Cluster)

"Data is presented per cluster. Hemoglobin levels at Community Screening Campaign 1 and 4 (CSC1 and CSC4) on day 1 per age group (5-9 years, 10-14 years, and ≥15 years) in the intervention versus the control arm was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant." (NCT01256658)
Timeframe: Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1

,
Interventiong/dL (Mean)
CSC1 5- 9 years (n= 899, 431)CSC4 5 - 9 years (n= 900, 396)CSC1 10 - 14 years (n= 873, 380)CSC4 10 - 14 years (n= 837, 359)CSC1 >= 15 years (n= 2904, 1279)CSC4 >= 15 years (n= 2760, 1136)
Control11.5912.1312.7112.7213.4913.42
Intervention11.6311.9712.3212.5813.1313.25

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Mean Number of Microscopy-confirmed Gametocyte Carriers at Day 1 of Community Screening Campaign 1,2,3,4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)

"Data is presented per cluster. Mean number of gametocyte carriers at Day 1 for Community Screening Campaign 1,2,3,4 (CSC1, CSC2, CSC3 and CSC4) was measured using gametocyte assessments (prevalence and density) via microscopy.~Mean measured in this analysis is the mean percent indicating the mean of percentages of cluster frequencies under the study arm for that particular category." (NCT01256658)
Timeframe: 12 months - period 1

,
Interventionparticipants (Mean)
CSC1/Day 1 (n= 543, 246)CSC2/Day 1 (n= 33, 130)CSC3/Day 1 (n= 23, 144)CSC4/Day 1 (n= 279, 113)
Control10.25.55.85.1
Intervention9.50.60.44.8

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Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Post Community Screening Campaign (CSC)

"Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000s) per person-year in post Community Screening Campaign (CSC), by study arm (individual level data) was detected by Rapid Diagnostic Test (RDT) (using a blood sample from each participant) and later confirmed to have a parasite density ≥5000/uL by microscopy.~Number of SMRC5000: sum of all SMRC5000 for all subjects in post CSC. Person-year observed: sum of duration (in days) in post CSC for all subjects present in study /365.25.~Number of SMRC5000 per person-year = number of SMRC5000/person-year observed." (NCT01256658)
Timeframe: 12 months - period 1

InterventionSMRC5000 per person-year (Number)
Intervention0.45
Control0.39

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Mean of Microscopy-confirmed Asymptomatic Carriers From Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)

"Data is presented per cluster. Mean number of asymptomatic carriers from Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) was measured by confirmed positive microscopy for P. falciparum asexual forms in participants with absence of clinical signs and symptoms of malaria.~Mean measured in this analysis is the mean percent indicting the mean of percentages of cluster frequencies under the study arm for that particular category." (NCT01256658)
Timeframe: 12 months - period 1

,
Interventionparticipants (Mean)
CSC1/ day 1 (n= 2428, 1153)CSC2/ day 1 (n= 237, 833)CSC3/ day 1 (n= 171, 741)CSC4/ day 1 (n= 2023, 815)
Control47.535.732.237.8
Intervention42.84.12.834.4

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Number of Asymptomatic Carriers With Complicated and Uncomplicated Episodes Combined

Number of asymptomatic carriers diagnosed with 1 Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000), 2 SMRC5000, 3 SMRC5000 and >3 SMRC5000 (complicated and uncomplicated episodes combined). Number of SMRC5000s is measured by Rapid diagnostic test (RDT) and later confirmed to have a parasite density ≥ 5000/uL by microscopy. (NCT01256658)
Timeframe: 12 months - period 1

,
Interventionparticipants (Number)
1 SMRC50002 SMRC50003 SMRC5000>3 SMRC5000
Control13638125
Intervention413963417

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Number of Microscopy and qRT-PCR-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4)

Number of gametocyte carriers at Community Screening Campaign 4 (CSC4) was measured via microscopy and confirmed using Quantitative Reverse Transcription PCR (qRT-PCR) at day 1 of CSC4. (NCT01256658)
Timeframe: Month 12 (CSC4/day 1) - period 1

,
Interventionparticipants (Number)
PositiveNegativeNot evaluable
Control4625113
Intervention5085141

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Number of Participants (Infants and Children (> 6 Months and < 5 Years)) With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)

Total number of participants (infants and children (> 6 months and < 5 years)) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed. (NCT01256658)
Timeframe: 12 months - period 1

,
Interventionparticipants (Number)
HospitalizationsSevere malaria episodesDeath
Control2152
Intervention2042

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Number of Participants With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)

Total number of participants (all ages) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed. (NCT01256658)
Timeframe: 12 months - period 1

,
Interventionparticipants (Number)
HospitalizationsSevere malaria episodesDeath
Control57931
Intervention681031

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Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000) in Asymptomatic Carriers at Any Time of Diagnosis (Per Cluster)

"Data is presented per cluster. Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) in asymptomatic carriers by study arm from all inhabitants diagnosed at any time for asymptomatic carriers. Number of SMRC5000s is measured by Rapid diagnostic test (RDT) and later confirmed to have a parasite density ≥ 5000/uL by microscopy." (NCT01256658)
Timeframe: 12 months - period 1

,
Interventionpercentage of participants (Mean)
1 SMRC50002 SMRC50003 SMRC5000>3 SMRC5000
Control9.492.780.970.31
Intervention15.253.561.280.67

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Percentage of COA566-treated Microscopy-confirmed Asymptomatic Carriers at Community Screening Campaign 1, 2 and 3 (CSC1, CSC2 and CSC3) With Parasitological Cure Rate at Day 7

Percentage of participants with parasitological cure confirmed via microscopy at day 7 after treatment with COA566. This assessment was done on asymptomatic carriers from Community Screening Campaigns 1, 2 and 3 (CSC1, CSC2 and CSC3) from the intervention group only. (NCT01256658)
Timeframe: Day 7 of CSC1, CSC2 and CSC3 - period 1

Interventionpercentage of participants (Number)
CSC1 (n= 2151)CSC2 (n=182)CSC3 (n=117)
Intervention99.510096.7

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Percentage of Microscopy-confirmed Gametocyte Carriers Treated With COA566 for Asymptomatic Carriers

Percentage of microscopy-confirmed gametocyte asymptomatic carriers treated with COA566 for asymptomatic carriers in Community Screening Campaign 1, 2 and 3 (CSC1, CSC2 and CSC3). (NCT01256658)
Timeframe: Day 1, day 7 and day 28 - period 1

Interventionpercentage of participants (Number)
CSC1 Day 1 (n= 3045)CSC 1 Day 7 (n= 3045)CSC 1 Day 28 (n= 3045)CSC2 Day 1 (n= 850)CSC2 Day 7 (n= 850)CSC3 Day 1 (n= 75)CSC3 Day 7 (n= 75)
Intervention15.71.40.12.60.14.00

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Time to Parasite Clearance (PCT)

Time from first dose until first total and continued disappearance of asexual parasite forms which remains at least a further 48 hours. (NCT01619878)
Timeframe: Up to 7 days

Interventionhours (Mean)
Cohort 129.1

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Time to Gametocyte Clearance (GCT)

Time from first dose until first total and continued disappearance of gametocytes which remains at least a further 48 hours. (NCT01619878)
Timeframe: Up to 7 days

Interventionhours (Mean)
Cohort 136.32

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Time to Fever Clearance (FCT)

Time from first dose to the first time the axillary body temperature decreased below and remained below 37.5° C for at least 48 hours. (NCT01619878)
Timeframe: Up to 7 days

Interventionhours (Mean)
Cohort 14.02

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Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate

Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28, corrected for re-infection by Polymerase Chain Reaction (PCR) assay. (NCT01619878)
Timeframe: 28 days

Interventionnumber of participants (Number)
Cohort 116

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Percent Change of Parasite Count From Baseline at 24 Hours

Percent change of parasite count from baseline at 24 hours (NCT01619878)
Timeframe: baseline, 24 hours

InterventionPercent Change (Mean)
Cohort 1-99.4

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Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline

Number of participants with parasite density at 72 hours after treatment initiation greater than or equal to 25 percent of parasite density at baseline. (NCT01619878)
Timeframe: 72 hours

Interventionparticipants (Number)
Cohort 10

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Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline

Number of participants with parasite density at 48 hours after treatment initiation greater than parasite density at baseline. (NCT01619878)
Timeframe: 48 hours

Interventionparticipants (Number)
Cohort 10

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Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42

Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 14 and day 42, corrected for re-infection by Polymerase Chain Reaction (PCR) assay. (NCT01619878)
Timeframe: Day 14 and 42

InterventionNumber of participants (Number)
Day 14Day 42
Cohort 11616

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Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42

Number of patients with clearance of asexual parasites at day 3, 7, 14, 28 and 42 after initiating study treatment. (NCT01619878)
Timeframe: Day 3, 7, 14, 28 and 42

Interventionparticipants (Number)
Day 3Day 7Day 14Day 28Day 42
Cohort 1201616107

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Drug-specific Parasite Reduction Ratio (PRR48) of ACT-451840 Over 48 Hours Using a New Approach

"After the blood stage Plasmodium falciparum challenge (BSPC), malaria parasitemia was measured by polymerase chain reaction (PCR) in regularly collected blood samples.~The subject-specific and drug-specific parasite reduction rates over a 48 h period (PRR48) were calculated following the data-driven method by Marquart et al. (2015), removing potential lag and tail phases prior to log-linear regression modeling." (NCT02223871)
Timeframe: 48 hours after study drug administration

InterventionRatio (Mean)
ACT-451840 500 mg73.6

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Drug-specific Parasite Reduction Ratio (PRR48) of ACT-451840 Over 48 Hours Using a Standardized Approach

"After the blood stage Plasmodium falciparum challenge (BSPC), malaria parasitemia was measured by polymerase chain reaction (PCR) in regularly collected blood samples.~The subject-specific and drug-specific parasite reduction rates over a 48 h period (PRR48) were calculated using an objective standardized approach (observed data over 48 h)" (NCT02223871)
Timeframe: 48 hours after study drug administration

InterventionRatio (Mean)
ACT-451840 500 mg234.5

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Maximum Plasma Concentration (Cmax) of ACT-451840

Cmax was directly derived from the plasma concentrations-time curves of ACT-451840. Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose. (NCT02223871)
Timeframe: From pre-dose to 144 hours after study drug adminsitration

Interventionng/mL (Geometric Mean)
ACT-451840 500 mg121.7

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Terminal Half-life [t(1/2)]

Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose (NCT02223871)
Timeframe: From pre-dose to144 hours after study drug adminsitration

InterventionHours (Geometric Mean)
ACT-451840 500 mg36.4

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Time to Reach Maximum Plasma Concentration (Tmax) of ACT-451840

tmax was directly derived from the plasma concentration-time curves of ACT-451840. Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose. (NCT02223871)
Timeframe: From pre-dose to144 hours after study drug administration

InterventionHours (Median)
ACT-451840 500 mg4.0

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Areas Under the Plasma Concentration-time Curve of ACT-451840

"Two AUCs were calculated using non-compartmental analysis: AUC(0-t) from pre-dose to last time-point of measure and AUC(0-inf) from pre-dose and extrapolated to infinity.~Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose" (NCT02223871)
Timeframe: From pre-dose to144 hours after study drug administration

Interventionng*h/mL (Geometric Mean)
AUC(0-t)AUC(0-inf)
ACT-451840 500 mg1254.81284.4

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Change From Baseline in Blood Pressure to End of Study (EOS)

Vital signs, including diastolic and systolic blood pressure (DBP/SBP), were measured at each outpatient visit up to 7 days after ACT-451840 administration, every day during confinement or when malaria symptoms were presented and at the end of study visit (EOS). Other measures were performed if required. (NCT02223871)
Timeframe: Day 28 (EOS)

InterventionmmHg (Median)
SBP at baseline (Day 0)SBP at EOS (Day 28)Change from Day 0 to Day 28 in SBPDBP at baseline (Day 0)DBP at EOS (Day 28)Change from Day 0 to Day 28 in DBP
ACT-451840 500 mg121.0125.52.566.070.50.5

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Change From Baseline in Body Temperature up to End of Study (EOS)

Body temperature was measured orally (NCT02223871)
Timeframe: Day 28 (EOS)

InterventionDegree Celsius (Median)
Temperature at baseline (Day 0)Temperature at EOS (Day 28)Change from Day 0 to Day 28 in temperature
ACT-451840 500 mg36.335.9-0.2

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Change From Baseline in Respiratory Rate to End of Study (EOS)

(NCT02223871)
Timeframe: Day 28 (EOS)

InterventionBreaths/min (Median)
Respiratory rate at baseline (Day 0)Respiratory rate at EOS (Day 28)Change from Day 0 to Day 28 in respiratory rate
ACT-451840 500 mg14161.5

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Proportion of Patients With Fever on Day 2 After Treatment

(NCT02389374)
Timeframe: day 2

InterventionParticipants (Count of Participants)
Chloroquine Primaquine 14days0
Artemether-lumefantrine Primaquine 1day0
Artemether-lumefantrine Primaquine 14days0

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Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count

(NCT02389374)
Timeframe: day 16

InterventionParticipants (Count of Participants)
Chloroquine Primaquine 14days34
Artemether-lumefantrine Primaquine 1dayNA
Artemether-lumefantrine Primaquine 14days7

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Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl)

(NCT02389374)
Timeframe: day 28

Interventionparticipants (Number)
Chloroquine Primaquine 14days0
Artemether-lumefantrine Primaquine 1day0
Artemether-lumefantrine Primaquine 14days0

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Proportion of Patients With Anaemia Less Than 8g/dl on Day 2

(NCT02389374)
Timeframe: on day 2

Interventionparticipants with Hb under 8g/dl (Number)
Chloroquine Primaquine 14days0
Artemether-lumefantrine Primaquine 1day2
Artemether-lumefantrine Primaquine 14days0

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Proportion of Patients With Any Parasitemia on Day 3 After Treatment

(NCT02389374)
Timeframe: day 3

Interventionparticipants (Number)
Chloroquine Primaquine 14days0
Artemether-lumefantrine Primaquine 1day2
Artemether-lumefantrine Primaquine 14days0

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Fractional Change in Hb Between Baseline and Day 9 and 16

(NCT02389374)
Timeframe: day 0 and 16

,,
Interventionpercent change Hb (Mean)
baseline to day 9baseline to day 16
Artemether-lumefantrine Primaquine 14days-13.8-8.3
Artemether-lumefantrine Primaquine 1day-7.7NA
Chloroquine Primaquine 14days-2.3-0.5

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Recurrence of Parasitaemia Within 16 Days of Follow up

(NCT02389374)
Timeframe: day 16

InterventionRecurrences of Parsitaemia (Number)
Chloroquine Primaquine 14days0
Artemether-lumefantrine Primaquine 1day0
Artemether-lumefantrine Primaquine 14days0

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The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients

(NCT02389374)
Timeframe: day 0

InterventionU/gHb (Median)
All Malaria Patients7.82

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The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment

The proportion of adverse and serious adverse events following unsupervised primaquine treatment until day 28 (NCT02389374)
Timeframe: during follow up (day 28)

Interventionevents (Number)
Chloroquine Primaquine 14days0
Artemether-lumefantrine Primaquine 1day0
Artemether-lumefantrine Primaquine 14days0

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Absence of Malaria Parasites in Blood.

Investigators will evaluate the percentage of patients who remain free of malaria parasites in the blood during the 28-day follow-up period. (NCT02600767)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Artemether-Lumefantrine73

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PK Run-in: Area Under the Blood Concentration-time Curve Over the Last 24 Hours After Treatment Dose (AUC0-24h) of KAF156

Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. AUC0-24h was determined using non-compartmental methods. (NCT03167242)
Timeframe: 0, 1, 3, 6, 12, 18 and 24 hours post-dose

Interventionhours*μg/mL (Geometric Mean)
PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day5.35

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PK Run-in, Part A and Part B: Parasite Clearance Time (PCT)

Parasite Clearance Time (PCT) is defined as the time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. In case a participant received rescue medication before (parasite) clearance, the time to event was censored at the first use of rescue medication. (NCT03167242)
Timeframe: 42 days post first dose

InterventionHours (Mean)
PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day49.9
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day48.4
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day46.6
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days39.9
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days51.4
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days49.7
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days48.1
Part A - Cohort 7: Coartem50.0
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day42.6
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days47.0
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days41.9
Part B - Cohort 4: Coartem35.6

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Part A and Part B: Area Under the Blood Concentration-time Curve Over the Last 24 Hours After Last Treatment Dose (AUC0-24h) of KAF156

Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. AUC0-24h was determined using non-compartmental methods. (NCT03167242)
Timeframe: 3, 6, 18 and 24 hours post last dose

Interventionhours*μg/mL (Geometric Mean)
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day9.84
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day21.7
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days9.95
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days5.91
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days11
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days10.9
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day11

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PK Run-in and Part A: Elimination Half-life (T½) of KAF156

Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. T½ was determined using non-compartmental methods. (NCT03167242)
Timeframe: 0, 1, 3, 6, 12, 18, 24, 27, 30, 36, 48, 72, 96 and 168 hours post last dose

InterventionHours (Mean)
PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day25.0
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day25.4
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day29.9
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days31.0
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days35.8
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days28.4
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days26.6

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Part A and Part B: Number of Participants With Reinfection Events

Reinfection is defined as appearance of asexual parasites after clearance of initial infection with a genotype different from those parasites present at baseline. Reinfection must be confirmed by PCR analysis. (NCT03167242)
Timeframe: 42 days post first dose

InterventionParticipants (Count of Participants)
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day3
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day7
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days4
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days7
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days8
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days2
Part A - Cohort 7: Coartem8
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day11
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days10
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days9
Part B - Cohort 4: Coartem10

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Part A and Part B: Number of Participants With Recrudescence Events

Recrudescence is defined as appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at baseline. Recrudescence must be confirmed by PCR analysis. (NCT03167242)
Timeframe: 42 days post first dose

InterventionParticipants (Count of Participants)
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day4
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day3
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days1
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days1
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days0
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days2
Part A - Cohort 7: Coartem0
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day12
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days7
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days3
Part B - Cohort 4: Coartem2

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Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29

"PCR-corrected ACPR defined as the absence of parasitaemia was evaluated at Day 29 (i.e., 28 days post first dose) based on the short half-life of the study drugs. Microscopic species identification was confirmed and determined by PCR genotyping methods to establish malaria recrudescence/reinfection.~A participant was considered as PCR-corrected ACPR at Day 29 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Day 29 irrespective of axillary temperature unless the presence of parasitaemia after 7 days was due to reinfection based on PCR. A presence of parasitaemia after 7 days of treatment initiation was considered as a reinfection only if the parasitaemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR." (NCT03167242)
Timeframe: 28 days post first dose

InterventionParticipants (Count of Participants)
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day46
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day45
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days47
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days47
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days44
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days42
Part A - Cohort 7: Coartem25
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day37
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days42
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days38
Part B - Cohort 4: Coartem21

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Part A and Part B: Maximum Peak Observed Concentration (Cmax) of KAF156

Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Cmax was determined using non-compartmental methods. (NCT03167242)
Timeframe: 3, 6, 18, 24, 27, 30, 48, 51, 54, 68, 72 and 168 hours post last dose

Interventionng/mL (Geometric Mean)
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day653
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day1470
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days1060
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days665
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days1470
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days1320
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day714
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days1060
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days1380

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PK Run-in and Part A (Cohorts 1 and 2): Time to Reach Maximum Blood Concentrations (Tmax) of KAF156

Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Tmax was determined using non-compartmental methods. (NCT03167242)
Timeframe: 0, 1, 3, 6, 12, 18, 24, 30, 48, 96 and 168 hours post last dose

InterventionHours (Mean)
PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day4.23
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day39.8
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day5.99

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Part A and Part B: Fever Clearance Time (FCT)

Fever Clearance Time (FCT) is defined as the time from the first dose until the first time the axillary body temperature decreased below and remained below 37.5°C axillary or 38.0°C oral/tympanic/rectal for at least a further 24 hours. In case a participant received rescue medication before (fever) clearance, the time to event was censored at the first use of rescue medication. (NCT03167242)
Timeframe: 42 days post first dose

InterventionHours (Mean)
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day18.7
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day22.5
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days20.3
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days16.6
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days17.5
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days19.2
Part A - Cohort 7: Coartem26.3
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day23.5
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days17.3
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days13.8
Part B - Cohort 4: Coartem22.9

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PK Run-in, Part A and Part B: Number of Participants With Parasitaemia

Parasitaemia is the quantitative content of parasites in the blood determined by microscopy examination validated methods. Only Plasmodium Falciparum asexual form is used for parasitaemia assessments. (NCT03167242)
Timeframe: 12, 24 and 48 hours post last dose

,,,,,,,,,,,
InterventionParticipants (Count of Participants)
12 hours post last dose24 hours post last dose48 hours post last dose
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day463913
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day46419
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days44388
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days524612
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days494210
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days493411
Part A - Cohort 7: Coartem22144
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day48414
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days484210
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days42365
Part B - Cohort 4: Coartem22171
PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day12113

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Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Uncorrected Adequate Clinical and Parasitological Response (ACPR)

"PCR-uncorrected ACPR defined as the absence of parasitaemia was evaluated at days 15, 29 and 43 (i.e., 14, 28 and 42 days post first dose).~A participant was considered as PCR-uncorrected ACPR at Days 15, 29 or 43 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Days 15, 29 or 43 irrespective of axillary temperature." (NCT03167242)
Timeframe: 14, 28 and 42 days post first dose

,,,,,,,,,,
InterventionParticipants (Count of Participants)
Day 14 post first doseDay 28 post first doseDay 42 post first dose
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day494642
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day474036
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days514845
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days535145
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days504541
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days514745
Part A - Cohort 7: Coartem272619
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day513429
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days524133
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days433631
Part B - Cohort 4: Coartem241511

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Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR)

"PCR-corrected ACPR defined as the absence of parasitaemia was evaluated at days 15 and 43 (i.e., 14 and 42 days post first dose). Microscopic species identification was confirmed and determined by PCR genotyping methods to establish malaria recrudescence/reinfection.~A participant was considered as PCR-corrected ACPR at Day 15 or Day 43 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Day 15 or Day 43 irrespective of axillary temperature unless the presence of parasitaemia after 7 days was due to reinfection based on PCR. A presence of parasitaemia after 7 days of treatment initiation was considered as a reinfection only if the parasitaemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR." (NCT03167242)
Timeframe: 14 and 42 days post first dose

,,,,,,,,,,
InterventionParticipants (Count of Participants)
Day 14 post first doseDay 42 post first dose
Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day4845
Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day4644
Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days4846
Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days4746
Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days4443
Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days4341
Part A - Cohort 7: Coartem2524
Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day4736
Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days4537
Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days4037
Part B - Cohort 4: Coartem2220

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Tmax

Tmax (NCT03334747)
Timeframe: Day 1, Day 3

,,
InterventionHour (Median)
Day 1Day 3
KAE609 10 mg QD 3 Days3.9252.7
KAE609 25 mg QD 3 Days4.2552.1
KAE609 50 mg QD 3 Days4.1252.0

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Tmax

Tmax (NCT03334747)
Timeframe: Day 1, Day 3

,,,,
InterventionHour (Median)
Day 1
KAE609 10 mg SD4.00
KAE609 150 mg SD8.07
KAE609 25 mg SD4.01
KAE609 50 mg SD4.12
KAE609 75 mg SD6.01

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Time to Recrudescence and Reinfection at Study Day 29

Time to recrudescence is calculated from the date of first study medication to the date of first event. Participants without recrudescence/reinfection after Day 7 are censored at the time of treatment failure or at the time of last parasite assessment if no treatment failure occured. (NCT03334747)
Timeframe: Day 29

,,,,,,
InterventionEvent probability (Number)
RecrudescenceReinfection
KAE609 150 mg SD32.513.3
KAE609 25 mg QD 3 Days10.014.3
KAE609 25 mg SD16.725.0
KAE609 50 mg QD 3 Days26.310.0
KAE609 50 mg SD16.05.0
KAE609 75 mg SD15.910.3
Pooled Coartem Control2.42.4

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Time to Recrudescence and Reinfection at Study Day 29

Time to recrudescence is calculated from the date of first study medication to the date of first event. Participants without recrudescence/reinfection after Day 7 are censored at the time of treatment failure or at the time of last parasite assessment if no treatment failure occured. (NCT03334747)
Timeframe: Day 29

,
InterventionEvent probability (Number)
Recrudescence
KAE609 10 mg QD 3 Days10.0
KAE609 10 mg SD12.5

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Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected and Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 15 and Day 29

PCR-corrected and PCR-uncorrected were evaluated at Days 15 and 29 (i.e., 14 and 28 days post-dose). The presence of parasitaemia after 7 days due to reinfection was considered as PCR-corrected ACPR. Missing blood smear data at Day 15 visit and thereafter were not considered as responder for the visit unless there was a later blood smear test indicating no parasitaemia. (NCT03334747)
Timeframe: Day 15, Day 29

,,,,,,,,
InterventionPercentage of Participants (Number)
Day 15: PCR correctedDay 15: PCR uncorrectedDay 29: PCR correctedDay 29: PCR uncorrected
KAE609 10 mg QD 3 Days90.090.090.090.0
KAE609 10 mg SD90.090.080.080.0
KAE609 150 mg SD77.377.368.259.1
KAE609 25 mg QD 3 Days95.095.090.080.0
KAE609 25 mg SD83.383.383.366.7
KAE609 50 mg QD 3 Days84.284.273.768.4
KAE609 50 mg SD95.295.285.781.0
KAE609 75 mg SD90.585.781.071.4
Pooled Coartem Control96.196.194.192.2

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Maximum Peak Observed Concentration (Cmax)

Maximum Peak Observed Concentration (Cmax) (NCT03334747)
Timeframe: Day 1, Day 3

,,
Interventionng/mL (Geometric Mean)
Day 1Day 3
KAE609 25 mg QD 3 Days503655
KAE609 50 mg QD 3 Days8281210
KAE609 10 mg QD 3 Days185235

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Maximum Peak Observed Concentration (Cmax)

Maximum Peak Observed Concentration (Cmax) (NCT03334747)
Timeframe: Day 1, Day 3

,,,,
Interventionng/mL (Geometric Mean)
Day 1
KAE609 75 mg SD1270
KAE609 10 mg SD179
KAE609 150 mg SD2360
KAE609 50 mg SD773
KAE609 25 mg SD379

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Half-life (T^1/2)

Half-life (T^1/2) (NCT03334747)
Timeframe: Upto day 15 post dose

,,
InterventionHour (Mean)
Day 1Day 3
KAE609 10 mg QD 3 Days18.532.4
KAE609 25 mg QD 3 Days17.430.1
KAE609 50 mg QD 3 Days32.829.9

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Parasite Clearance Time (PCT)

Parasite Clearance Time (PCT) is defined as the time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. In case a patient received rescue medication before (parasite) clearance, the time to event was censored at the first use of rescue medication. (NCT03334747)
Timeframe: Day 29

InterventionHours (Mean)
KAE609 10 mg SD26.8
KAE609 10 mg QD 3 Days27.7
KAE609 25 mg SD14.0
KAE609 25 mg QD 3 Days11.4
KAE609 50 mg SD11.1
KAE609 50 mg QD 3 Days9.8
KAE609 75 mg SD8.7
KAE609 150 mg SD8.0
Pooled Coartem Control36.2

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Number of Participants With at Least 2 CTCAE Grades Increase From Baseline in Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)

The occurrence of at least 2 CTCAE grades increase from baseline in ALT or AST during the 4 weeks study period was evaluated to characterize hepatic safety aspects of single and multiple ascending doses of KAE609 in adult malaria subjects for treatment of uncomplicated malaria caused by plasmodium falciparum. If 2 patients in a 10 patient cohort (Cohorts 1 and 2) or 3 patients in a 20 patient cohort (Cohorts 3, 4 and 5) had at least 2 CTCAE grades increase from Baseline in ALT or AST, recruitment was suspended and a review of liver safety (and any other relevant data) by safety review committee was initiated. Any further progression of the study was based on the decision by the safety review committee. (NCT03334747)
Timeframe: Day 29

InterventionPercentage of Participants (Number)
KAE609 10 mg SD11.1
KAE609 10 mg QD 3 Days0
KAE609 25 mg SD0
KAE609 25 mg QD 3 Days0
KAE609 50 mg SD0
KAE609 50 mg QD 3 Days0
KAE609 75 mg SD0
KAE609 150 mg SD4.5
Pooled Coartem Control3.9

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Half-life (T^1/2)

Half-life (T^1/2) (NCT03334747)
Timeframe: Upto day 15 post dose

,,,,
InterventionHour (Mean)
Day 1
KAE609 10 mg SD24.4
KAE609 150 mg SD29.9
KAE609 25 mg SD35.1
KAE609 50 mg SD31.5
KAE609 75 mg SD25.3

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Fever Clearance Time (FCT)

Fever Clearance Time (FCT) is defined as the time from the first dose until the first time the axillary body temperature decreased below and remained below 37.5°C axillary or 38.0°C oral/tympanic/rectal for at least a further 24 hours. In case a patient received rescue medication before (fever) clearance, the time to event was censored at the first use of rescue medication. (NCT03334747)
Timeframe: Day 29

InterventionHours (Mean)
KAE609 10 mg SD3.9
KAE609 10 mg QD 3 Days2.0
KAE609 25 mg SDNA
KAE609 25 mg QD 3 Days22.0
KAE609 50 mg SD2.4
KAE609 50 mg QD 3 Days7.2
KAE609 75 mg SD5.7
KAE609 150 mg SD9.9
Pooled Coartem Control13.0

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AUC0-24

AUC0-24 (NCT03334747)
Timeframe: Day 1, Day 3

,,
Interventionh*ug/mL (Geometric Mean)
Day 1Day 3
KAE609 10 mg QD 3 Days2.593.90
KAE609 25 mg QD 3 Days8.3910.9
KAE609 50 mg QD 3 Days15.621.6

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AUC0-24

AUC0-24 (NCT03334747)
Timeframe: Day 1, Day 3

,,,,
Interventionh*ug/mL (Geometric Mean)
Day 1
KAE609 10 mg SD2.77
KAE609 150 mg SD40.4
KAE609 25 mg SD5.14
KAE609 50 mg SD11.6
KAE609 75 mg SD21.4

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Number of Participants With Local and Systemic Adverse Events in Year One

Incidence of local and systemic adverse events (AEs) graded by severity occurring within 7 days after each vaccine administration in year one (NCT03510481)
Timeframe: Within 7 days after each vaccination in year one

InterventionParticipants (Count of Participants)
Experimental Arm 1: Dosing Interval 0, 8, 16, and 54 Weeks39
Experimental Arm 2: Dosing Interval 0, 1, 4, and 42 Weeks27
Placebo Comparator 3a: Dosing Interval 0, 8, 16, and 54 Weeks19
Placebo Comparator 3b: Dosing Interval 0, 1, 4, and 42 Weeks11

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Number of Participants With Local and Systemic Adverse Events in Year Two

Incidence of local and systemic adverse events (AEs) graded by severity occurring within 7 days after vaccine administration during year two (booster dose) (NCT03510481)
Timeframe: Within 7 days after each vaccination in year two

InterventionParticipants (Count of Participants)
Experimental Arm 1: Dosing Interval 0, 8, 16, and 54 Weeks5
Experimental Arm 2: Dosing Interval 0, 1, 4, and 42 Weeks12
Placebo Comparator 3a: Dosing Interval 0, 8, 16, and 54 Weeks3
Placebo Comparator 3b: Dosing Interval 0, 1, 4, and 42 Weeks2

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Break Through Infections

Number of subjects that required rescue treatment with atovaquone/proguanil due to a positive thick smear in combination with symptoms following NF135.C10 immunizations despite mefloquine prophylaxis (Cohort A) or presumptive artemether/lumefantrine treatment (Cohort B). (NCT03813108)
Timeframe: From day 0 until 28 days after each immunization (28 days)

,
Interventionparticipants (Number)
Break through following immunization 1Break through following immunization 2Break through following immunization 3
1: NF135 CPS-immunization Challenged by NF1351034
2: Low Dose NF135 CPS-immunization Challenged by NF1351035

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Magnitude of Adverse Events After NF135.C10 CPS Immunization

The severity of adverse events will be recorded (mild/moderate/severe) for each adverse event (NCT03813108)
Timeframe: Cohort A: Inclusion until 35 days after challenge infection (35 weeks) Cohort B: Inclusion - premature end of study (22 weeks)

,,
InterventionAdverse events (Number)
Mild adverse events (grade 1)Moderate adverse events (grade 2)Severe adverse events (grade 3)Serious adverse events (grade 4)
1: NF135 CPS-immunization Challenged by NF13510820110
2: Low Dose NF135 CPS-immunization Challenged by NF13512835100
3: NF135 CPS-immunization (A/L) Cohort B12131191

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Break Through Infections

Number of subjects that required rescue treatment with atovaquone/proguanil due to a positive thick smear in combination with symptoms following NF135.C10 immunizations despite mefloquine prophylaxis (Cohort A) or presumptive artemether/lumefantrine treatment (Cohort B). (NCT03813108)
Timeframe: From day 0 until 28 days after each immunization (28 days)

Interventionparticipants (Number)
Break through following immunization 1
3: NF135 CPS-immunization (A/L) Cohort B2

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Frequency of Adverse Events After NF135.C10 CPS Immunization

The number of adverse events will be recorded by the trial clinicians for all participants. (NCT03813108)
Timeframe: Cohort A: Inclusion until 35 days after challenge infection (35 weeks) Cohort B: Inclusion - premature end of study (22 weeks)

InterventionAdverse events (Number)
1: NF135 CPS-immunization Challenged by NF135139
2: Low Dose NF135 CPS-immunization Challenged by NF135173
3: NF135 CPS-immunization (A/L) Cohort B172

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Time to Parasitemia

The effectiveness of CPS-immunization with NF135 sporozoites to protect against malaria challenge infection with homologous N135.C10 or heterologous NF54 sporozoites will be determined by the time to parasitemia in immunized versus non-immunized volunteers after the challenge infection. (NCT03813108)
Timeframe: Day 1 - 28 after malaria challenge infection (28 days)

Interventiondays to parasitaemia (Median)
1: NF135 CPS-immunization Challenged by NF1359
2: Low Dose NF135 CPS-immunization Challenged by NF1357
5: Control Group Challenged by NF135.C10 Cohort A7

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Adequate Clinical and Parasitological Response (ACPR)

Adequate Clinical and Parasitological Response (ACPR): Absence of parasitemia on day 28 irrespective of axillary temperature without previously meeting any of the criteria of Early Treatment Failure or Late Clinical Failure or Late Parasitological Failure. (NCT04222088)
Timeframe: Day 0-28

InterventionParticipants (Count of Participants)
Artemether-lumefantrine (Coartem™) + Primaquine74
Chloroquine + Primaquine72

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Late Parasitological Failure (LPF)

"Patients with late parasitological failure without PCR correction:~• Presence of parasitemia on any day from day 7 to day 28 and axillary temperature <37.5 ºC, without previously meeting any of the criteria of Early Treatment Failure or Late Clinical Failure." (NCT04222088)
Timeframe: day 7 to day 28

Interventionparticipants (Number)
Artemether-lumefantrine (Coartem™) + Primaquine0
Chloroquine + Primaquine2

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Late Clinical Failure (LCF)

"Patients with late clinical failure without PCR correction:~Development of danger signs or severe malaria on any day from day 4 to day 28 in the presence of parasitaemia, without previously meeting any of the criteria of Early Treatment Failure;~Presence of parasitemia and axillary temperature ≥37.5 ºC (or history of fever in low/moderate transmission areas) on any day from day 4 to day 28, without previously meeting any of the criteria of Early Treatment Failure." (NCT04222088)
Timeframe: Day 4-28

Interventionparticipants (Number)
Artemether-lumefantrine (Coartem™) + Primaquine1
Chloroquine + Primaquine0

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Early Treatment Failure (ETF)

"The classification of treatment outcomes will be based on an assessment of the parasitological and clinical outcomes of antimalarial treatment according to the latest guidelines of WHO. Accordingly, all patients will be classified as having an Early Treatment Failure by microscopy results P without PCR correction~Development of danger signs or severe malaria on day 1, day 2, or day 3 in the presence of parasitemia;~Parasitaemia on day 2 higher than day 0 count irrespective of axillary temperature;~Parasitaemia on day 3 with axillary temperature ≥37.5 ºC;~Parasitaemia on day 3 ≥25% of count on day 0." (NCT04222088)
Timeframe: Day 1-3

Interventionparticipants (Number)
Artemether-lumefantrine (Coartem™) + Primaquine0
Chloroquine + Primaquine0

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Parasitaemia at First Dose of Treatment With Riamet® (Cohorts 1 and 2)

(NCT04310085)
Timeframe: Day 1 to day 21

InterventionPARASITES/mL (Geometric Mean)
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 13936.7
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 29454.3

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Incidence of Positive PCR and Parasitaemia of ≥5000 Parasites Per mL Blood.

(NCT04310085)
Timeframe: Day 1 with PfSPZ-DVI Challenge and Day 28 (per cohort).

InterventionParticipants (Count of Participants)
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 18
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 28

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Time to First Dose of Treatment With Artemether-lumefantrine (Riamet®) (Cohorts 1 and 2)

(NCT04310085)
Timeframe: Day 1 to day 21

InterventionDays (Geometric Mean)
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 112.09
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 212.04

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Time to First PCR Positivity.

For the purpose of this study, 'PCR positivity' is used for the 'protocol-defined PCR positivity' (NCT04310085)
Timeframe: Day 1 to day 21

InterventionDays (Geometric Mean)
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 19.76
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 29.60

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Parasitaemia at the Time Parasitaemia ≥5000 Parasites Per mL Blood (Cohorts 1 and 2)

(NCT04310085)
Timeframe: Day 1 to day 21

InterventionPARASITES/mL (Geometric Mean)
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 112807.4
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 218831.7

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Change in Malaria Clinical Score From PfSPZ-DVI Challenge Until Parasite Clearance.

"Malaria Clinical Score~14 signs/symptoms frequently associated with malaria will be graded using a 4-point scale (absent: 0; mild: 1; moderate: 2; severe: 3): headache, myalgia (muscle ache), arthralgia (joint ache), fatigue/lethargy, malaise (general discomfort/uneasiness), chills/shivering/rigors, sweating/hot spells, anorexia, nausea, vomiting, abdominal discomfort, fever, tachycardia and hypotension.~Malaria clinical score is calculated as the sum of all (14) malaria sign and symptoms scores (maximum score is 42)." (NCT04310085)
Timeframe: Day 1 until end of study, day 28.

Interventionscore on a scale (Mean)
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 19.63
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 213.0

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Time to Parasitaemia of ≥5000 Parasites Per mL Blood (Cohorts 1 and 2)

(NCT04310085)
Timeframe: Day 1 to day 21

InterventionDays (Median)
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 111.19
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 211.46

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Incidence and Severity of Observed or Self-reported Adverse Events (AEs) Considered PfSPZ-DVI Challenge Inoculum-related.

Based on their start date(time), AEs will be allocated to the phase during which they started (Screening, Challenge, Rescue). Each AE will therefore be reported in only one phase. (NCT04310085)
Timeframe: Screening until end of study, day 28.

,
InterventionIncidence (Number)
Adverse eventsAny grade 3 or more adverse eventScreening Adverse eventsChallenge adverse eventsChallenge adverse events grade 3 or aboveRescue adverse eventsRescue adverse events grade 3 or above
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 113107061
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 212205072

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Parasitaemia at First PCR Positivity

POSITIVE PARASITAEMIA IS DEFINED AS qPCR OUTCOME >=250 PARASITES per mL BLOOD. (NCT04310085)
Timeframe: Day 1 to day 21

InterventionPARASITES/mL (Geometric Mean)
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 1367.2
PfSPZ-DVI Challenge and Artemether Lumefantrine Cohort 2711.7

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AUECt of pSTAT3 Inhibition

Area under the effect curve (AUECt) of pSTAT3 inhibition levels (NCT04456634)
Timeframe: up to 28 days after AL+Rux and AL+placebo administration

Interventionng.hr/mL (Mean)
AL&RUX551
AL& Placebo186

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Number of Participants With Changes in Heart Rate

Safety signals, trends or significant differences in heart rate ( beats / min)between treatment groups were were reported during the study up to 28 days after AL+Rux and AL+Placebo administration in all participants by treatment regimens. (NCT04456634)
Timeframe: up to 28 days after AL+Rux and AL+placebo administration

InterventionParticipants (Count of Participants)
AL&RUX1
AL& Placebo0

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Number of Participants With Changes of Systolic and Diastolic Blood Pressure

Safety signals, trends or significant differences in blood pressure between treatment groups were were reported during the study up to 28 days after AL+Rux and AL+Placebo administration in all participants by treatment regimens. (NCT04456634)
Timeframe: up to 28 days after AL+Rux and AL+placebo administration

InterventionParticipants (Count of Participants)
AL&RUX2
AL& Placebo0

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Number of Participants With ECG Changes

Safety signals, trends or significant differences in QT, QTcB and QTcF, QRS between treatment groups were were reported during the study up to 28 days after AL+Rux and AL+Placebo administration in all participants by treatment regimens. (NCT04456634)
Timeframe: up to 28 days after AL+Rux and AL+placebo administration

InterventionParticipants (Count of Participants)
AL&RUX2
AL& Placebo0

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