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meglumine antimoniate

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Description

Meglumine Antimoniate: ANTIMONY salt of meglumine that is used in the treatment of LEISHMANIASIS. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID64953
SCHEMBL ID146372
MeSH IDM0428130

Synonyms (25)

Synonym
meglumine antimonate
2168-rp
1-deoxy-1-(methylamino)-d-glucitol, compound with antimonic acid (1:1)
protostib
einecs 205-108-3
methylglucamine antimonate
1-deoxy-1-(methylamino)glucitol antimonate(v)
glucantime
n-methylglucamine antimonate
133-51-7
d-glucitol, 1-deoxy-1-(methylamino)-, trioxoantimonate(1-)
meglumine antimoniate
glucantim
n-methyl glucamine antimoniate
75g4tw236w ,
unii-75g4tw236w
meglumine antimonate [who-dd]
n-methylglucamine antimonate [mi]
AKOS025310684
SCHEMBL146372
DTXSID4043935
(2r,3r,4r,5s)-6-(methylamino)hexane-1,2,3,4,5-pentaol stibenate
mfcd01725422
Q2757969
DB13732

Research Excerpts

Overview

Meglumine antimoniate is a pentavalent antimonial widely used in the classic treatment of leishmaniasis.

ExcerptReferenceRelevance
"Meglumine antimoniate is a pentavalent antimonial widely used in the classic treatment of leishmaniasis. "( Drugs and nanoformulations for the management of
Abreu, F; Lima, F; Nico, D; Taveira, I; Verdan, M, 2023
)
2.35
"Meglumine antimoniate (MA) is a pentavalent antimony drug used to treat leishmaniases. "( Effects of in utero and lactational exposure to SbV on rat neurobehavioral development and fertility.
Coelho, DR; De-Carvalho, RR; Paumgartten, FJ; Rocha, RC; Saint'Pierre, TD, 2014
)
1.85
"Meglumine antimoniate (MA) is a pentavalent antimonial (Sb(V)) drug used to treat leishmaniasis. "( Embryotoxicity of meglumine antimoniate in the rat.
Chahoud, I; Paumgartten, FJ,
)
1.91

Effects

ExcerptReferenceRelevance
"Meglumine antimoniate compounds have been the mainstay of treatment for cutaneous leishmaniasis (CL) for decades. "( Should we continue to indicate meglumine antimoniate as first-line treatment for cutaneous leishmaniasis in Tunisia.
Badri, T; Fenniche, S; Hamida, MB; Hammami, H; Jannet, SB; Mlika, RB; Mokhtar, I,
)
1.86

Actions

ExcerptReferenceRelevance
"Meglumine antimoniate can cause severe reactions, which can lead to death if not promptly identified."( Severe adverse reactions to meglumine antimoniate in the treatment of visceral leishmaniasis: a report of 13 cases in the southwestern region of Brazil.
Bóia, MN; Brustoloni, YM; Cunha, RV; Dorval, ME; Fernandes, TD; Oliveira, AL, 2009
)
1.37

Treatment

Treatment with meglumine antimoniate (Glucantime) had the lowest average cost per patient (US$ 167.66), followed by miltefosine (US $ 259.92) in the outpatient treatment regimen. Treatment significantly reduced parasite burdens in the livers and lungs (by about 10-fold and > 100-fold, respectively) but not those in the spleens.

ExcerptReferenceRelevance
"Meglumine antimoniate treatment was tolerated with no side effects."( Childhood cutaneous leishmaniasis: report of 117 cases from Iran.
Shajari, G; Taghaviardakani, A; Talaei, R; Talari, SA; Vakili, Z, 2006
)
1.06
"Meglumine antimoniate treatment of cutaneous hamster lesions resulted in marked concomitant decrease in size of the lesions and numbers of amastigotes within the lesions examined 1 wk after treatment."( Development of Leishmania (Viannia) panamensis lesions and relationship of numbers of amastigotes to lesion area on antimony-treated and untreated hamsters.
Chapman, WL; Hanson, WL; Lovelace, JK; Waits, VB, 1991
)
1
"Treatment with meglumine antimoniate (Glucantime) was ineffective."( [Cutaneous leishmaniasis of the vermilion border of the upper lip extending to the oral mucosa].
Boumezzourh, A; Chiheb, S; Dessay, M; Elfatoiki, FZ; Elkhalfaoui, N; Maksouri, H; Riyad, M, 2020
)
0.9
"Treatment with meglumine antimoniate had the lowest average cost per patient (US$ 167.66), followed by miltefosine (US$ 259.92) in the outpatient treatment regimen. "( Estimating direct costs of the treatment for mucosal leishmaniasis in Brazil.
Assis, TM; Carvalho, JP; Cota, G; Simões, TC, 2021
)
0.97
"Treatment with meglumine antimoniate was successful, although the diagnosis was made only five months later."( Disseminated cutaneous leishmaniasis caused by Leishmania braziliensis in Southern Brazil.
Kazuma, FJ; Membrive, NA; Reinhold-Castro, KR; Silveira, TGV; Teixeira, JJV; Teodoro, U, 2017
)
0.79
"Treatment with meglumine antimoniate had to be interrupted in six patients, with QTc prolongation the reason for the interruption in three patients."( Cutaneous leishmaniasis in Switzerland: first experience with species-specific treatment.
Blum, JA; Hatz, C; Mosimann, V; Neumayr, A, 2013
)
0.73
"Treatment with meglumine antimoniate 60 mg/kg/day (Glucantime) intramuscularly for 15 days, followed by intralesional administration 1 ml weekly for 4 weeks led to complete recovery."( Leishmaniasis of the lip in a patient with Down's syndrome.
Aste, N; Atzori, L; Ferreli, C; Pistis, P; Zucca, M, 2004
)
0.66
"Treatment with meglumine antimoniate was efficacious."( [Visceral leishmaniasis in an immunocompetent subject, acquired in the Pyrenees region].
Djossou, F; Ibanez, C; Le Bras, M; Longy-Boursier, M; Malvy, D; Vatan, R, 2006
)
0.67
"Treatment with meglumine antimoniate (50 mg SbV/kg.day) significantly reduced the parasite burdens in the livers and lungs (by about 10-fold and > 100-fold, respectively) but not those in the spleens."( Therapeutic effect of reference antileishmanial agents in murine visceral leishmaniasis due to Leishmania infantum.
Buffet, PA; Derouin, F; Garin, YJ; Nassar, N; Sulahian, A, 1996
)
0.63
"Treatment with meglumine antimoniate (Glucantime) administered iv at a dosage of 20 mg antimony/kg body weight/day for 60 days resulted in visible improvement of the lesions, but not in clinical or parasitological cure."( Diffuse cutaneous leishmaniasis acquired in Peru.
De Rivera, MV; Franke, ED; Kruger, JH; Lucas, CM; Tovar, AA; Wignall, FS, 1990
)
0.62

Toxicity

Glucantime is a promutagenic compound that causes damage to DNA after reduction of pentavalent antimony. This new delivery system could offer a new pharmacological tool for the treatment of leishmaniosis.

ExcerptReferenceRelevance
" Finally, the results shows that the treatment with pentavalent antimony in doses of 40 mg Sb/kg/day was less tolerated on account of its renal toxic effects."( [The evaluation of the tolerance and nephrotoxicity of pentavalent antimony administered in a dose of 40 mg Sb V/kg/day, 12/12 hr, for 30 days in the mucocutaneous form of leishmaniasis].
de Paula, CD; Furtado, Rde S; Leal, PP; Rodrigues, ME; Rosa, TT; Sampaio, JH; Sampaio, RN; Veiga, JP,
)
0.13
" Adverse effects were observed in 14 (56%) VL episodes."( High frequency of serious side effects from meglumine antimoniate given without an upper limit dose for the treatment of visceral leishmaniasis in human immunodeficiency virus type-1-infected patients.
Corzo, JE; de la Rosa, R; Delgado, J; González-Moreno, MP; Leal, M; Lissen, E; Macías, J; Pineda, JA; Sánchez-Quijano, A, 1999
)
0.56
"9% and no serious adverse side effects."( Clinical features, epidemiology, and efficacy and safety of intralesional antimony treatment of cutaneous leishmaniasis: recent experience in Turkey.
Allahverdiyev, AM; Culha, G; Durdu, M; Memisoglu, HR; Uzun, S, 2004
)
0.32
"Glucantime is the most common stibied derivative used to treat cutaneous leishmaniasis (CL) in Tunisia; however adverse effects have been reported."( [Glucantime injection: benefit versus toxicity].
Bouassida, S; Boudaya, S; Maalej, N; Masmoudi, A; Mseddi, M; Souissi, A; Turki, H; Zahaf, A, 2005
)
0.33
"This retrospective study deals with the various adverse of intramuscular glucantime used for CL."( [Glucantime injection: benefit versus toxicity].
Bouassida, S; Boudaya, S; Maalej, N; Masmoudi, A; Mseddi, M; Souissi, A; Turki, H; Zahaf, A, 2005
)
0.33
"Nineteen patients (21%) receiving intramuscular Glucantime developed adverse effects."( [Glucantime injection: benefit versus toxicity].
Bouassida, S; Boudaya, S; Maalej, N; Masmoudi, A; Mseddi, M; Souissi, A; Turki, H; Zahaf, A, 2005
)
0.33
" No adverse effect of MA on the mothers was noted at any dose level."( Developmental toxicity of meglumine antimoniate and transplacental transfer of antimony in the rat.
De-Carvalho, RR; Miekeley, N; Miranda, ES; Paumgartten, FJ, 2006
)
0.63
" It has been proposed that the more active and toxic trivalent antimony form Sb(III) plays a critical role in their antileishmanial activity and toxicity."( Role of residual Sb(III) in meglumine antimoniate cytotoxicity and MRP1-mediated resistance.
de Oliveira, FB; Demicheli, C; Dzamitika, SA; Falcão, CA; Frézard, F; Garnier-Suillerot, A; Marbeuf, C; Rossi-Bergmann, B, 2006
)
0.63
" The aim of this retrospective study was to determine the adverse effects of intralesional Glucantime and to calculate the risk/benefit rate of this treatment."( [Adverse effects of intralesional Glucantime in the treatment of cutaneous leishmaniosis].
Boudaya, S; Maalej, N; Masmoudi, A; Turki, H; Zahaf, A, 2006
)
0.33
"The adverse effects of intralesional Glucantime are mostly infections, mainly observed in cephalic localization, and stibio-intolerance."( [Adverse effects of intralesional Glucantime in the treatment of cutaneous leishmaniosis].
Boudaya, S; Maalej, N; Masmoudi, A; Turki, H; Zahaf, A, 2006
)
0.33
" A questionnaire recording adverse effects was completed by a physician in each treatment centre."( Generic sodium stibogluconate is as safe and effective as branded meglumine antimoniate, for the treatment of tegumentary leishmaniasis in Isiboro Secure Park, Bolivia.
Bermúdez, H; Boelaert, M; Chappuis, F; Desjeux, P; Dujardin, JC; Garcia, L; Rojas, E, 2006
)
0.57
" It may create severe adverse effects."( [Cardiotoxicity of n-methyl-glucamine antimoniate (Glucantime). A case report].
Ameur, HB; Amor, SB; Becher, SB; Fitouri, Z; Matoussi, N, 2007
)
0.34
" Adverse effects were recorded passively in all the subjects, and actively, using a standardized questionnaire, in a sub-group of the patients given AmB."( Safety and effectiveness of amphotericin B deoxycholate for the treatment of visceral leishmaniasis in Uganda.
Cavailler, P; Chappuis, F; Couffignal, S; Loutan, L; Mueller, Y; Nguimfack, A; Rwakimari, JB, 2008
)
0.35
" This new delivery system could offer a new pharmacological tool for the treatment of leishmaniosis that reduces the doses required, lowering toxic side effects because of meglumine antimoniate."( In vitro evaluation of the effectiveness and cytotoxicity of meglumine antimoniate microspheres produced by spray drying against Leishmania infantum.
Carrió, J; García, E; Miñarro, M; Pérez, P; Portus, M; Pujals, G; Suñé-Negre, JM; Tico, JR, 2008
)
0.78
" Adverse effects related to systemic administration of Glucantime are frequent."( [Adverse events related to systemic treatment using Glucantime for cutaneous leishmaniasis: a report from Tunisia].
Badri, T; Ben Brahim, M; Ben Jannet, S; Chouk, S; Daghfous, R; El Aïdli, S; Fenniche, S; Marrrak, H; Mlika, BR; Mokhtar, I, 2008
)
0.35
"2%) presented product-related adverse events concerning the gastrointestinal tract."( Comparative study on the short term efficacy and adverse effects of miltefosine and meglumine antimoniate in dogs with natural leishmaniosis.
Bianciardi, P; Mateo, M; Maynard, L; Miró, G; Vischer, C, 2009
)
0.58
" These findings indicate that Glucantime is a promutagenic compound that causes damage to DNA after reduction of pentavalent antimony (SbV) into the more toxic trivalent antimony (SbIII) in the antimonial drug meglumine antimoniate."( Genotoxic effects of the antileishmanial drug Glucantime.
Alves, EV; Arruda, VO; de Azevedo, AP; Lima, MI; Monteiro, SG; Pereira, SR, 2010
)
0.55
" During treatment, patients underwent periodic blood exams and were interviewed weekly about the incidence of adverse symptoms."( Antimony in plasma and skin of patients with cutaneous leishmaniasis--relationship with side effects after treatment with meglumine antimoniate.
Caldas, ED; Neves, DB; Sampaio, RN, 2009
)
0.56
" The main adverse symptoms were arthralgia and myalgia; laboratory results showed mainly lymphocytosis and eosinophilia."( Antimony in plasma and skin of patients with cutaneous leishmaniasis--relationship with side effects after treatment with meglumine antimoniate.
Caldas, ED; Neves, DB; Sampaio, RN, 2009
)
0.56
"We found some significant correlations between antimony concentrations, adverse symptoms and laboratory alterations, strengthening the hypothesis of a dose-dependent relationship between antimony concentration in plasma and skin and side effects."( Antimony in plasma and skin of patients with cutaneous leishmaniasis--relationship with side effects after treatment with meglumine antimoniate.
Caldas, ED; Neves, DB; Sampaio, RN, 2009
)
0.56
" The safety of miltefosine-allopurinol combination therapy was confirmed by lack of effect on renal and hepatic parameters and adverse reactions."( Multicentric, controlled clinical study to evaluate effectiveness and safety of miltefosine and allopurinol for canine leishmaniosis.
Bianciardi, P; Cañavate, C; Cruz, I; Miró, G; Mortarino, M; Oliva, G; Vischer, C, 2009
)
0.35
" The vaccine was safe and well tolerated."( A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine when used in combination with meglumine antimoniate for the treatment of cutaneous leishmaniasis.
Alves, FP; Ashman, JA; Beckmann, AM; Bogatzki, LY; Campos-Neto, A; Coler, RN; Cowgill, KD; Fernandes, DF; Kahn, SJ; Nascimento, E; Piazza, FM; Pine, SO; Reed, SG; Vieira, EP, 2010
)
0.57
" Thirty-three non-serious and six serious adverse events (two pancreatitis, one renal failure and three deaths) were observed in 26 patients."( Safety and effectiveness of meglumine antimoniate in the treatment of Ethiopian visceral leishmaniasis patients with and without HIV co-infection.
Balasegaram, M; Hailu, A; Hailu, W; Hurissa, Z; Omollo, R; Tafes, H; Weldegebreal, T; Yifru, S, 2010
)
0.65
" No severe adverse events occurred."( Randomized controlled clinical trial to access efficacy and safety of miltefosine in the treatment of cutaneous leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil.
Chrusciak Talhari, C; Chrusciak-Talhari, A; da Silva, RM; de Oliveira Penna, G; Dietze, R; Gadelha Yamashita, EP; Lima Machado, PR; Talhari, S, 2011
)
0.37
"Among the problems associated to leishmaniasis, the two most outstanding ones are the lack of a vaccine and the adverse effects caused by drugs use for its control."( An experimental approach to studying the effectiveness and safety of meglumine antimoniate formulations.
Delgado, G; Granados, D; Mariño, A; Plaza, D; Sánchez, Y, 2011
)
0.6
" This study aimed to evaluate the adverse effects of intralesional injection of meglumine antimoniate (Glucantime(®) ) and its influence on clinical laboratory parameters."( Adverse effects of intralesional meglumine antimoniate and its influence on clinical laboratory parameters in the treatment of cutaneous leishmaniasis.
Esfandiarpour, I; Farajzadeh, S; Fathabadi, EA; Heshmatkhah, A; Rahnama, Z, 2012
)
0.89
"The occurrence of severe adverse reactions, particularly of anaphylactic shock, should be considered before treatment with Glucantime(®) is initiated."( Adverse effects of intralesional meglumine antimoniate and its influence on clinical laboratory parameters in the treatment of cutaneous leishmaniasis.
Esfandiarpour, I; Farajzadeh, S; Fathabadi, EA; Heshmatkhah, A; Rahnama, Z, 2012
)
0.66
" We found that MMWC was toxic for two parasite forms."( In vitro analysis regarding the safety of components used in a film-based therapeutic system loaded with meglumine antimoniate and its activity toward Leishmania major experimental infections: a preliminary study.
Barbosa, H; Delgado, G; Gutiérrez, J; Pinzón, J; Vallejo, B, 2013
)
0.6
"Currently, the treatment of leishmaniasis is increasingly insufficient as current antileishmanial drugs have many disadvantages such as toxic side effects, high cost, and growing drug resistance."( Meglumine antımoniate-TiO2@Ag nanoparticle combinations reduce toxicity of the drug while enhancing its antileishmanial effect.
Abamor, ES; Allahverdiyev, AM; Bagirova, M; Rafailovich, M, 2017
)
0.46
" Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available."( Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil.
Borges, MM; Carranza-Tamayo, CO; Noronha, EF; Pranchevicius, MC; Romero, GA,
)
0.13
" All patients reported adverse events (AE)."( Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil.
Borges, MM; Carranza-Tamayo, CO; Noronha, EF; Pranchevicius, MC; Romero, GA,
)
0.13
"N-methylglucamine antimoniate and amphotericin B deoxycholate have similar efficacy and adverse events rate in pediatric patients with VL."( Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil.
Borges, MM; Carranza-Tamayo, CO; Noronha, EF; Pranchevicius, MC; Romero, GA,
)
0.13
" The presence of vesicles at the site of heat application was the most common adverse event reported associated with the use of TT; while vomiting (31."( A phase II multicenter randomized study to evaluate the safety and efficacy of combining thermotherapy and a short course of miltefosine for the treatment of uncomplicated cutaneous leishmaniasis in the New World.
Alvarez, F; Arana, B; Boni, M; Echevarria, J; Jiménez, A; Llanos-Cuentas, A; López, L; Méndez, C; Quintero, J; Ramos, AP; Rode, J; Tabares, Y; Valencia, B; Vélez, I, 2022
)
0.72
"4% alone or in combination with national standard treatment is safe with high-efficacy rate and warrants further investigation during phase 3 clinical trials."( Pilot study of safety and efficacy of topical liposomal amphotericin B for cutaneous leishmaniasis caused by Leishmania major in Islamic Republic of Iran.
Afshari, F; Eskandari, S; Firooz, A; Jaafari, M; Javadi, A; Khamesipour, A; Mohammadi, A; Mortazavi, H; Tasbihi, M, 2022
)
0.72

Pharmacokinetics

ExcerptReferenceRelevance
"The pharmacokinetic profile of antimony in dogs was defined by administering it intravenously, intramuscularly and subcutaneously as N-methylglucamine antimoniate at a dose of about 25."( Pharmacokinetics of N-methylglucamine antimoniate after intravenous, intramuscular and subcutaneous administration in the dog.
Belloli, C; Carli, S; Ceci, L; De Natale, G; Madonna, M; Marcotrigiano, GO; Ormas, P; Tassi, P, 1994
)
0.29
"07 microg/kg (4 days after the fourth dose) and a half-life of 4 days for antimony elimination from the bone marrow."( Pharmacokinetic and parasitological evaluation of the bone marrow of dogs with visceral leishmaniasis submitted to multiple dose treatment with liposome-encapsulated meglumine antimoniate.
Costa Val, AP; Demicheli, C; Frézard, F; Melo, MN; Michalick, MS; Rocha, OG; Schettini, DA; Souza, LF, 2005
)
0.52
" We hypothesized that there are age-dependent pharmacokinetic differences of potential clinical relevance."( Pharmacokinetics of antimony in children treated for leishmaniasis with meglumine antimoniate.
Cruz, A; Herwaldt, BL; Palacios, R; Rainey, PM; Saravia, NG; Stagni, G; Trujillo, R, 2007
)
0.57
"001), a 16% lower peak concentration (32."( Pharmacokinetics of antimony in children treated for leishmaniasis with meglumine antimoniate.
Cruz, A; Herwaldt, BL; Palacios, R; Rainey, PM; Saravia, NG; Stagni, G; Trujillo, R, 2007
)
0.57
" Considering the current concept for the evaluation of pharmacokinetic parameters at early phases of drug discovery, we developed a formulation of MA-encapsulated into phosphatidylserine liposomes (MA-LP) and analyzed the in vitro antileishmanial activity, physicochemical properties, and pharmacokinetic profile in a mice model."( Pharmacokinetic of meglumine antimoniate encapsulated in phosphatidylserine-liposomes in mice model: A candidate formulation for visceral leishmaniasis.
Borborema, SET; de Andrade Junior, HF; do Nascimento, N; Osso Junior, JA; Tempone, AG, 2018
)
0.81
" Pharmacodynamic (PD) parameters of antimicrobials are based on the relationship between drug concentrations/exposure and microbial kill."( Immuno-pharmacokinetics of Meglumine Antimoniate in Patients With Cutaneous Leishmaniasis Caused by Leishmania (Viannia).
Alexander, N; Cossio, A; Giraldo-Parra, L; Gómez, MA; Gore Saravia, N; Navas, A; Prieto, MD, 2021
)
0.92

Compound-Compound Interactions

The objective of this study was to compare the clinical efficacy of intramuscular pentavalent antimonial compound meglumine antimoniate alone and in combination with intralesional therapy in the treatment of Old World cutaneous leishmaniasis.

ExcerptReferenceRelevance
" Patients were randomized to receive either GM-CSF, 5 micrograms/kg daily (intravenously or subcutaneously), or placebo for ten days, in combination with pentavalent antimony, 10-20 mg/kg daily for 20 days."( Granulocyte-macrophage colony-stimulating factor in combination with pentavalent antimony for the treatment of visceral Leishmaniasis.
Badaró, F; Badaró, R; Carvalho, JS; Ho, JL; Johnson, WD; Jones, TC; Nascimento, C; Reed, SG; Russo, D, 1994
)
0.29
"BALB/c mice with an experimental visceral leishmaniasis produced by Leishmania infantum were treated with aminosidine sulphate alone or combined with meglumine antimoniate."( Efficacy of aminosidine administered alone or in combination with meglumine antimoniate for the treatment of experimental visceral leishmaniasis caused by Leishmania infantum.
Derouin, F; Gangneux, JP; Garin, YJ; Sulahian, A, 1997
)
0.73
"To determine the efficacy and safety of imiquimod in combination with meglumine antimoniate in treating cutaneous leishmaniasis."( Imiquimod in combination with meglumine antimoniate for cutaneous leishmaniasis: a randomized assessor-blind controlled trial.
Dowlati, Y; Eskandari, SE; Firooz, A; Ghoorchi, MH; Gorouhi, F; Hooshmand, B; Khamesipour, A; Khatami, A; Nassiri-Kashani, M; Rashighi-Firoozabadi, M, 2006
)
0.86
"To determine the efficacy and the immunomodulatory function of Z-100 alone or combined with meglumine antimoniate on Leishmania amazonensis infection."( A trial of immunotherapy against Leishmania amazonensis infection in vitro and in vivo with Z-100, a polysaccharide obtained from Mycobacterium tuberculosis, alone or combined with meglumine antimoniate.
Barroso, PA; Calvopina, M; Hashiguchi, Y; Kato, H; Korenaga, M; Marco, JD, 2007
)
0.75
" The objective of this study was to compare the clinical efficacy of intramuscular pentavalent antimonial compound meglumine antimoniate alone and in combination with intralesional therapy in the treatment of Old World cutaneous leishmaniasis."( Clinical efficacy of intramuscular meglumine antimoniate alone and in combination with intralesional meglumine antimoniate in the treatment of old world cutaneous leishmaniasis.
Hussain, I; Janjua, SA; Munir, A, 2008
)
0.83
" The LEISH-F1+MPL-SE vaccine was safe and immunogenic in CL patients and appeared to shorten their time to cure when used in combination with meglumine antimoniate chemotherapy."( A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine when used in combination with meglumine antimoniate for the treatment of cutaneous leishmaniasis.
Alves, FP; Ashman, JA; Beckmann, AM; Bogatzki, LY; Campos-Neto, A; Coler, RN; Cowgill, KD; Fernandes, DF; Kahn, SJ; Nascimento, E; Piazza, FM; Pine, SO; Reed, SG; Vieira, EP, 2010
)
0.77
"MA) either alone or combined with application of a silver or a non-silver polyester dressing on their lesions for 6 weeks."( Dressings combined with injection of meglumine antimoniate in the treatment of cutaneous leishmaniasis: a randomized controlled clinical trial.
Dowlati, Y; Firooz, A; Khamesipour, A; Khatami, A; Mehryan, P; Rahshenas, M; Talaee, R; Tehrani, S, 2013
)
0.66
" The major objective of the present study was to explore the effect of immunomodulator-levamisole in combination with Glucantime in end-stage unresponsive patients with anthroponotic CL (ACL)."( A single-group trial of end-stage patients with anthroponotic cutaneous leishmaniasis: Levamisole in combination with Glucantime in field and laboratory models.
Aflatoonian, MR; Bamorovat, M; Fekri, A; Heshmatkhah, A; Keyhani, A; Khosravi, A; Mostafavi, M; Naderi, A; Oliaee, RT; Parizi, MH; Sharifi, I; Varma, RS, 2019
)
0.51
"The aim of this 6-month, randomized, blinded, controlled clinical trial was to compare the efficacy and safety of aminosidine-allopurinol combination with that of meglumine antimoniate-allopurinol combination for the treatment of leishmaniosis in dogs without stage III or IV chronic kidney disease."( A randomized, blinded, controlled clinical trial comparing the efficacy of aminosidine (paromomycin)-allopurinol combination with the efficacy of meglumine antimoniate-allopurinol combination for the treatment of canine leishmaniosis due to Leishmania inf
Apostolidis, K; Athanasiou, LV; Chatzis, MK; Ikonomopoulos, J; Kasabalis, D; Leontides, LS; Mataragka, A; Petanides, T; Saridomichelakis, MN; Xenoulis, PG, 2020
)
0.95
"We decided to investigate the antileishmanial, cellular mechanisms, and cytotoxic effects of green synthesized Zinc nanoparticles (ZnNPs) alone and combined with glucantime against Leishmania major infection."( Antileishmanial, cellular mechanisms, and cytotoxic effects of green synthesized zinc nanoparticles alone and in combined with glucantime against Leishmania major infection.
Ezzatkhah, F; Ghasemian Yadegari, J; Khudair Khalaf, A; Mahmoudvand, H; Mohammadi, HR; Shakibaie, M, 2023
)
0.91
" Effects of ZnNPs alone and combined with glucantime (MA) were studied on cutaneous leishmaniasis in BALB/c mice."( Antileishmanial, cellular mechanisms, and cytotoxic effects of green synthesized zinc nanoparticles alone and in combined with glucantime against Leishmania major infection.
Ezzatkhah, F; Ghasemian Yadegari, J; Khudair Khalaf, A; Mahmoudvand, H; Mohammadi, HR; Shakibaie, M, 2023
)
0.91

Bioavailability

ExcerptReferenceRelevance
" The apparent bioavailability of antimony was > 100 per cent for the intramuscular and 100 per cent for the subcutaneous routes."( Pharmacokinetics of N-methylglucamine antimoniate after intravenous, intramuscular and subcutaneous administration in the dog.
Belloli, C; Carli, S; Ceci, L; De Natale, G; Madonna, M; Marcotrigiano, GO; Ormas, P; Tassi, P, 1994
)
0.29
" The pharmacokinetic parameters and bioavailability of antimony were calculated after each route of administration in each dog."( Disposition of antimony after the administration of N-methylglucamine antimoniate to dogs.
Alberola, J; Arboix, M; Esteban, M; Valladares, JE, 1996
)
0.29
"The efficiency of antileishmanial agents may be enhanced by improving their bioavailability with a colloidal drug carrier."( Action of pentamidine-bound nanoparticles against Leishmania on an in vivo model.
Astier, A; Bories, C; Deniau, M; Durand, R; Fusai, T; Houin, R; Paul, M; Rivollet, D, 1994
)
0.29
" This unexpected behaviour was attributed, in part, to the fact that the heating of equimolar mixture of MA and beta-CD (first step of preparation of MA/beta-CD composition) induced the depolymerization of MA from high-molecular weight Sb complexes into 1:1 Sb-meglumine complex, resulting in an enhanced oral bioavailability of Sb."( Enhanced oral delivery of antimony from meglumine antimoniate/beta-cyclodextrin nanoassemblies.
Bahia, AP; da Silva, JB; de Melo, AL; Demicheli, C; Frézard, F; Le Moyec, L; Martins, PS; Pimenta, AM; Salerno, M, 2008
)
0.61
"Previous studies have shown that the association of the drug meglumine antimoniate (MA) with β-cyclodextrin can improve its bioavailability by the oral route."( Mixed antimony(V) complexes with different sugars to modulate the oral bioavailability of pentavalent antimonial drugs.
Andrade, AP; Demicheli, C; Fernandes, FR; Ferreira, WA; Frézard, F; Islam, A, 2014
)
0.64
" The main objective of the present work was to interfere in the structural organization of these nanoassemblies so as to investigate their influence on the oral bioavailability of Sb, and ultimately, optimize an oral formulation of SbL8 for the treatment of cutaneous leishmaniasis."( Polarity-sensitive nanocarrier for oral delivery of Sb(V) and treatment of cutaneous leishmaniasis.
Andrade, MS; Corrêa-Júnior, JD; Demicheli, C; Fernandes, FR; Ferreira, LA; Frézard, F; Lanza, JS; Magalhães-Paniago, R; Melo, MN; Vilela, JM, 2016
)
0.43

Dosage Studied

First-line therapy was meglumine antimoniate for all patients, given at the standard Sb(v) dosage of 20 mg/kg/day for 21 to 28 days. Nine days after the dose, me glumine Antimoniate was reintroduced at a dosage of 11.5mg/kg body weight/d im.

ExcerptRelevanceReference
" braziliensis LTB259) a dose-response line is obtained at a higher concentration range (20 mM to 70 mM)."( In vitro activity of meglumine antimoniate, a pentavalent antimonial drug, on Leishmania promastigotes.
Moreira, ES; Petrillo-Peixoto, ML, 1991
)
0.6
" Treatment with meglumine antimoniate (Glucantime) administered iv at a dosage of 20 mg antimony/kg body weight/day for 60 days resulted in visible improvement of the lesions, but not in clinical or parasitological cure."( Diffuse cutaneous leishmaniasis acquired in Peru.
De Rivera, MV; Franke, ED; Kruger, JH; Lucas, CM; Tovar, AA; Wignall, FS, 1990
)
0.63
" These may be prevented by respecting the maximal suggested dosage of 6 cg/kg/day, regular clinical checks of pulse, blood pressure and temperature, biological follow-up of serum creatinin, transaminases and routine electrocardiography."( [Toxicity of Glucantime. A case].
Ben Salah, N; Katlama, C; Pichard, E; Régnier, B; Vachon, F, 1985
)
0.27
" With this latter dosage or with 104 mg/kg/day there was no acute toxicity of formycin B to bone marrow or formed elements of the blood."( Leishmania donovani: oral efficacy and toxicity of formycin B in the infected hamster.
Berman, JD; Hanson, WL; Keenan, CM; Lamb, SR; Waits, VB, 1983
)
0.27
" Seemingly, liposomes can markedly reduce the drug dosage required for equivalent treatment of visceral leishmaniasis in dogs."( Antileishmanial activity of liposome-encapsulated meglumine antimonate in the dog.
Alving, CR; Chapman, WL; Hanson, WL; Hendricks, LD, 1984
)
0.27
" A dosage of 25 to 50 mg/kg/day of N-Methyl-glucamine in two or three treatment series, produced the healing of the cutaneous sore, without electrocardiographic alterations which could be interpreted as signs of myocardial toxicity."( [Electrocardiographic evaluation of the cardiotoxicity of N-methylglucamine antimonate (R glucantime)].
Carrasco, H; Fuenmayor, A; García Muller, R; Mendoza, E; Ramírez Benedetti, J; Torrealba, W; Valera, M,
)
0.13
") schedule, especially when a low dosage of Glucantime (30 mg/kg/d x 20 d) was used."( Antimonial treatment of hamsters infected with Leishmania (Viannia) panamensis: assessment of parasitological cure with different therapeutic schedules.
Martinez, JE; Travi, BL; Zea, A,
)
0.13
" In 10 out of 12 patients receiving a dose of 5 mg/kg/day and 9 out of 11 patients with a dosage of 20 mg/kg/day a complete epithelization was noted by the end of treatment."( Treatment of American cutaneous leishmaniasis: a comparison between low dosage (5 mg/kg/day) and high dosage (20 mg/kg/day) antimony regimens.
Gonçalves-Costa, SC; Mattos, M; Oliveira-Neto, MP; Pirmez, C; Schubach, A, 1997
)
0.3
"8 micrograms ml-1 found after this dosage regimen were higher than those observed after the single dose administration of 100 mg kg-1 24 h-1."( Pharmacokinetics of meglumine antimoniate after administration of a multiple dose in dogs experimentally infected with Leishmania infantum.
Alberola, J; Arboix, M; Cristòfol, C; Franquelo, C; Gállego, M; Portús, M; Riera, C; Valladares, JE, 1998
)
0.62
" Unfortunately, pharmacokinetics and optimal dosage of diamidines are not well-known, and numerous adverse events are described."( [Treatment of infantile visceral leishmaniasis].
Dumon, H; Faraut-Gambarelli, F; Garnier, JM; Gire, C; Minodier, P; Piarroux, R, 1999
)
0.3
" Few data are available on the toxicity and efficacy of these drugs at the dosing schedule recommended by the Centers for Disease Control and Prevention (CDC) (Atlanta, GA)."( High frequency of serious side effects from meglumine antimoniate given without an upper limit dose for the treatment of visceral leishmaniasis in human immunodeficiency virus type-1-infected patients.
Corzo, JE; de la Rosa, R; Delgado, J; González-Moreno, MP; Leal, M; Lissen, E; Macías, J; Pineda, JA; Sánchez-Quijano, A, 1999
)
0.56
" Although pentavalent antimonials (Sb5+) are the mainstay of leishmanial therapy and have been used for more than 50 years, dosage regimens have been repeatedly modified and the best one has not been fully identified."( Response of cutaneous leishmaniasis (chiclero's ulcer) to treatment with meglumine antimoniate in Southeast Mexico.
Andrade-Narvaez, FJ; Canto-Lara, SB; Damian-Centeno, AG; Vargas-Gonzalez, A, 1999
)
0.54
" Nine days after the dose, meglumine antimoniate was reintroduced at a dosage of 11."( Antimony excretion in a patient with renal impairment during meglumine antimoniate therapy.
Hantson, P; Haufroid, V; Lambert, M; Luyasu, S, 2000
)
0.85
" We developed a simple and reliable microassay based on N-ribohydrolase dosage using 4-nitrophenyl-beta-D-ribofuranoside (NPR) substrate for the quantification of Leishmania infantum."( Assessment of Leishmania promastigote growth in vitro by means of nucleoside hydrolase activity determination.
Derouin, F; Gangneux, JP; Garin, YJ; Meneceur, P; Pannier-Stockman, C; Sulahian, A, 2001
)
0.31
" In vitro drug resistance was evaluated and the comparative analyses of dose-response curves showed that the susceptibility pattern of the sensitive line did not change after passage in animals, but a decrease in drug resistance was observed in resistant cell lines recovered from the mammalian host."( Cell surface carbohydrates and in vivo infectivity of glucantime-sensitive and resistant Leishmania (Viannia) guyjanensis cell lines.
Anacleto, C; Andrade, AF; Ferreira, AV; Gazola, KC; Michalick, MS; Moreira, ES, 2001
)
0.31
" Dogs of group 1 were treated by use of meglumine antimonate (100 mg/kg, SC, q 24 h) administered concurrently with allopurinol (15 mg/kg, PO, q 12 h) for 20 days and then with allopurinol alone at the same dosage for the subsequent 30 days."( Serum concentrations of acute-phase proteins in dogs with leishmaniosis during short-term treatment.
Bernal, LJ; Cerón, JJ; Martínez-Subiela, S, 2003
)
0.32
" Both had symptomatic relapses 3 months later, and recovered following re-treatment with AmBisome administered intravenously at a dosage of 3 mg/Kg for ten consecutive days."( [Mediterranean visceral leishmaniasis in immunocompetent children. Report of two cases relapsed after specific therapy].
Colomba, C; Frasca Polara, V; Salsa, L; Scarlata, F; Titone, L, 2004
)
0.32
" Ten were treated with meglumine antimonate (20 mg/kg/day for 21 days) and remained in hospital for 11-28 days (median 19 days), while 19 patients received liposomal amphotericin B at four different dosage schemes and were in hospital for 6-11 days (median 7 days)."( Treatment of paediatric visceral leishmaniasis: amphotericin B or pentavalent antimony compounds?
Delis, D; Kafetzis, DA; Liapi, G; Mavrikou, M; Stabouli, S; Velissariou, IM, 2005
)
0.33
"Despite more than half a century of use in leishmaniasis, antimony therapy still presents serious problems concerning dosage and toxicity."( An alternative antimonial schedule to be used in cutaneous leishmaniasis when high doses of antimony are undesirable.
de Oliveira-Neto, MP; Mattos, Mda S,
)
0.13
" Hydroxyurea completely eliminated Leishmania parasites when it was used at a dosage of 10 or 100 microg/ml."( Activity of hydroxyurea against Leishmania mexicana.
Galindo-Sevilla, N; Mancilla-Ramirez, J; Martinez-Rojano, H; Quiñonez-Diaz, L, 2008
)
0.35
" First-line therapy was meglumine antimoniate for all patients, given at the standard Sb(v) dosage of 20 mg/kg/day for 21 to 28 days."( Pediatric visceral leishmaniasis in Albania: a retrospective analysis of 1,210 consecutive hospitalized patients (1995-2009).
Foto, E; Gradoni, L; Kuneshka, L; Petrela, R; Zavalani, F, 2010
)
0.67
"Antimony (Sb) disposition and toxicity was evaluated in Leishmania braziliensis-infected monkeys (Macaca mulatta) treated with a 21-d course of low (LOW) or standard (STD) meglumine antimoniate (MA) dosage regimens (5 or 20 mg Sb(V)/kg body weight/d im)."( Disposition of antimony in rhesus monkeys infected with Leishmania braziliensis and treated with meglumine antimoniate.
Friedrich, K; Grimaldi, G; Marchevsky, RS; Miekeley, N; Paumgartten, FJ; Porrozzi, R; Vieira, FA, 2012
)
0.79
" Data were collected on age, sex, origin, method of diagnosis, adverse effects of drugs, duration of hospitalization, duration of treatment and dosage up to the onset of adverse effects."( Historical series of patients with visceral leishmaniasis treated with meglumine antimoniate in a hospital for tropical diseases, Maceió-AL, Brazil.
Pedrosa, CM; Ribeiro, SA; Rocha, TJ; Silveira, LJ,
)
0.36
" The dosage and duration of treatment with Glucantime were consistent with that advocated by the Ministry of Health."( Historical series of patients with visceral leishmaniasis treated with meglumine antimoniate in a hospital for tropical diseases, Maceió-AL, Brazil.
Pedrosa, CM; Ribeiro, SA; Rocha, TJ; Silveira, LJ,
)
0.36
"This study aimed to determine if the use of nanoparticles loaded with meglumine antimoniate could reach and targeting infected organs with leishmaniasis, reducing the dosage used and promoting less adverse effects."( Polycaprolactone Antimony Nanoparticles as Drug Delivery System for Leishmaniasis.
Albernaz, MS; Cerqueira-Coutinho, C; do Carmo, FS; Santos-Oliveira, R; Sousa-Batista, AJ,
)
0.37
" Docking results proved the affinity of NAm to IFN-γ, which can affirm the increased levels of IFN-γ, IL-12p40 and TNF-α as well as reductions in IL-10 secretion with a dose-response effect, especially in the combination group."( The potential role of nicotinamide on Leishmania tropica: An assessment of inhibitory effect, cytokines gene expression and arginase profiling.
Babaei, Z; Bamorovat, M; Keyhani, A; Khosravi, A; Mostafavi, M; Mousavi, SM; Oliaee, RT; Salarkia, E; Sharifi, F; Sharifi, I; Tavakoly, R, 2020
)
0.56
"tropica infection, at a dosage of ∼2."( The effect of oral miltefosine in treatment of antimoniate resistant anthroponotic cutaneous leishmaniasis: An uncontrolled clinical trial.
Darchini-Maragheh, E; Goyonlo, VM; Kiafar, B; Layegh, P; Tayyebi, M, 2021
)
0.62
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (937)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990102 (10.89)18.7374
1990's160 (17.08)18.2507
2000's261 (27.85)29.6817
2010's312 (33.30)24.3611
2020's102 (10.89)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 56.89

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 Index56.89 (24.57)
Research Supply Index7.13 (2.92)
Research Growth Index4.79 (4.65)
Search Engine Demand Index95.85 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (56.89)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials125 (11.18%)5.53%
Reviews61 (5.46%)6.00%
Case Studies283 (25.31%)4.05%
Observational6 (0.54%)0.25%
Other643 (57.51%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (26)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Phase III Clinical Trial for American Tegumentary Leishmaniasis: Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis [NCT01301924]Phase 2/Phase 372 participants (Actual)Interventional2008-10-31Completed
Multicentric Efficacy and Safety Study of Antileishmanial Drugs for Treatment of Visceral Leishmaniasis in Brazil [NCT01310738]Phase 4378 participants (Actual)Interventional2011-02-28Terminated(stopped due to DSMB recommendation based on programmed interim analysis.)
Phase III Clinical Trial for Mucosal or Mucocutaneous Leishmaniasis. Comparison Between the Standard and Alternative Antimonial Schemes [NCT01301937]Phase 2/Phase 376 participants (Anticipated)Interventional2008-10-31Recruiting
Randomized Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis at Federal District, Brazil [NCT01377974]Phase 240 participants (Actual)Interventional2009-07-31Completed
Reduced Doses of Antimony Plus Recombinant Human GM-CSF Compared With Antimony in Standard Doses for Cutaneous Leishmaniasis: a Randomized, Single-blind, Placebo-controlled, Pilot Study [NCT00973128]Phase 240 participants (Actual)Interventional2004-02-29Completed
Open Label Randomized Study to Assess Safety and Efficacy of Azithromycin Versus Meglumine Antimoniate to Treat Cutaneous Leishmaniasis [NCT00682656]Phase 2/Phase 348 participants (Actual)Interventional2008-06-30Terminated(stopped due to Efficacy issues on test arm)
Pilot Study of Efficacy of Topical Nano-liposomal Meglumine Antimoniate (Glucantime) or Paromomycin in Combination With Systemic Glucantime for the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL) Caused by Leishmania Tropica [NCT01050777]Early Phase 130 participants (Anticipated)Interventional2011-03-31Completed
Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients Infected With Leishmania (Viannia) Braziliensis in Bahia State, Brazil. An Open Uncontrolled Trial. [NCT00818818]Phase 413 participants (Actual)Interventional2008-08-31Completed
Efficacy and Safety of Amphotericin B Deoxycholate Compared to Meglumine Antimoniate for Treatment of Visceral Leishmaniasis in Brazilian Children [NCT01032187]Phase 4101 participants (Actual)Interventional2007-10-31Completed
Phase 3 Randomized Trial Comparing Fluconazole to Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Caused by L. Braziliensis and L. Guyanensis [NCT01953744]Phase 353 participants (Actual)Interventional2014-02-28Terminated(stopped due to Low cure rate in the study (fluconazole) group)
Efficacy and Safety of Thermotherapy in Combination With Miltefosine Compared Iltefosine Monotherapy for the Treatment of New World Cutaneous Leishmaniasis: A Phase III, Open Label, Multicenter Randomized Trial [NCT04515186]Phase 3184 participants (Actual)Interventional2021-01-26Active, not recruiting
Clinical Trial to Assess Efficacy and Safety of Orally Administered Miltefosine in Brazilian Patients With Cutaneous Leishmaniasis Compared to the Standard Care as Active Control [NCT00600548]Phase 2180 participants (Actual)Interventional2007-07-31Completed
EFFICACY AND SAFETY OF A SHORT COURSE OF THE COMBINATION OF MILTEFOSINE AND ANTIMONY TO TREAT CUTANEOUS LEISHMANIASIS IN BOLIVIA [NCT00537953]Phase 20 participants InterventionalRecruiting
Randomized Clinical Trial of the Efficacy and Tolerability of Oral Miltefosine Versus Parenteral Antimony for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia [NCT00487253]Phase 3150 participants (Anticipated)Interventional2007-07-31Active, not recruiting
Double Blind, Randomized Controlled Trial, to Evaluate the Effectiveness of a Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis [NCT00317629]Phase 3178 participants (Actual)Interventional2006-05-31Terminated(stopped due to An interim analysis showed that nitric oxide patches are not enough effective)
Phase IV Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Low-Dose Pentavalent Antimony Compared to the Standard Dose in Patients With Cutaneous Leishmaniasis Caused by Leishmania (Viannia)Braziliensis [NCT00317980]Phase 4280 participants (Actual)Interventional2006-02-28Completed
Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate 20 Mg/Kg/Day Versus Meglumine Antimoniate 10 Mg/Kg/Day And Tablet Allopurinol 20 Mg/Kg/Day [NCT00480883]400 participants (Anticipated)Interventional2008-01-31Completed
Phase II Randomized Study of Allopurinol Versus Glucantime Versus Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil [NCT00004755]Phase 2375 participants Interventional1995-09-30Completed
Therapeutic Gain of Adding the Immunomodulator Pentoxifylline to the Treatment of Cutaneous Leishmaniasis [NCT01464242]Phase 2/Phase 375 participants (Actual)Interventional2011-11-30Completed
Miltefosine and GM-CSF in Cutaneous Leishmaniasis: a Randomized and Controlled Trial [NCT03023111]Phase 3300 participants (Actual)Interventional2017-06-30Completed
The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: An Open-label, Randomized Clinical Trial in Brazil [NCT02530697]Phase 2160 participants (Anticipated)Interventional2015-08-31Active, not recruiting
Evaluation of Efficacy of Intra-lesional Injections of Glucantime Once Weekly in Comparison With Twice Weekly in the Treatment of Acute Anthroponotic Cutaneous Leishmaniasis (ACL) [NCT04340128]Phase 30 participants Interventional2007-05-31Completed
Phase 3 Open-label Study of Efficacy and Safety of Miltefosine or Thermotherapy vs Glucantime for Cutaneous Leishmaniasis in Colombia. [NCT00471705]Phase 3437 participants (Actual)Interventional2006-06-30Completed
Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase as an Adjunct in Cutaneous Leishmaniasis Therapy: a Randomized and Controlled Trial [NCT03294161]Phase 250 participants (Actual)Interventional2014-12-31Completed
A Phase 2, Randomized, Unicentric Clinical Trial With Dose Scaling for Safety, Tolerability and Efficacy Assessment of 18-Methoxycoronaridine Administered to Cutaneous Leishmaniasis Patients [NCT03084952]Phase 252 participants (Anticipated)Interventional2021-05-31Not yet recruiting
Tofacitinib Associated With Meglumine Antimoniate in the Control of American Tegumentary Leishmaniasis. A Randomized and Controlled Clinical Trial. [NCT06011343]Phase 2/Phase 322 participants (Anticipated)Interventional2023-10-01Not yet recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00471705 (3) [back to overview]Complete Clinical Response
NCT00471705 (3) [back to overview]Failure
NCT00471705 (3) [back to overview]Recurrence

Complete Clinical Response

"Complete Clinical response: Initial cure plus the absence of recurrences or mucosal lesions for 6 months after the end of treatment.~Note: nitial cure: Complete re-epithelialization of all ulcers and complete disappearance of the induration up to 3 months after the end of treatment." (NCT00471705)
Timeframe: Until 6 months posttreatment

Interventionparticipants (Number)
Miltefosine85
Glucantime®103
Thermotherapy86

[back to top]

Failure

At least 50% increase in lesion size at the end of treatment, absence of clinical response at 6 weeks, or any sign of lesion activity 3 months after the end of treatment (NCT00471705)
Timeframe: Until 3 months posttreatment

Interventionparticipants (Number)
Miltefosine34
Glucantime®14
Thermotherapy42

[back to top]

Recurrence

Reactivation of the lesion at the original site after cure or mucosal compromise during follow-up. (NCT00471705)
Timeframe: Until 6 months post-treatment

InterventionParticipants (Number)
Miltefosine3
Glucantime®4
Thermotherapy6

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