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antimony sodium gluconate

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Description

Antimony Sodium Gluconate: Antimony complex where the metal may exist in either the pentavalent or trivalent states. The pentavalent gluconate is used in leishmaniasis. The trivalent gluconate is most frequently used in schistosomiasis. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID156588474
MeSH IDM0001475

Synonyms (3)

Synonym
antimony sodium gluconate
stibogluconate sodium nonahydrate
AKOS040739199

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Both treatment regimens were well tolerated and they were associated with a similar incidence of reversible toxic effects."( Safety and efficacy of high-dose sodium stibogluconate therapy of American cutaneous leishmaniasis.
Andujar, J; Ballou, WR; Berman, JD; Chulay, JD; Gordon, DM; McClain, JB; Shanks, GD, 1987
)
0.27
" Adverse effects were common and necessitated interruption of treatment in 28% of cases, but they were generally reversible."( Safety and efficacy of intravenous sodium stibogluconate in the treatment of leishmaniasis: recent U.S. military experience.
Aronson, NE; Beard, JS; Benson, PM; Coyne, PE; Endy, TP; Gambel, JM; Gasser, RA; Grogl, M; Jackson, JE; Johnson, SC; Kreutzer, RD; Magill, AJ; Oster, CN; Tally, JD; Wortmann, GW, 1998
)
0.3
" One patient (SB alone) had experienced a serious adverse event: cardiotoxicity at day 8 (myocarditis and ECG changes) which caused withdrawal from the study."( A prospective randomized, comparative, open-label trial of the safety and efficacy of paromomycin (aminosidine) plus sodium stibogluconate versus sodium stibogluconate alone for the treatment of visceral leishmaniasis.
Houlihan, HH; Kanyok, TP; Olliaro, P; Pandey, AK; Sinha, GP; Thakur, CP; Zaniewski, AE,
)
0.13
"Use of parenteral pentavalent antimonials to treat leishmaniasis is associated with a range of cardiological, biochemical and haematological adverse effects."( Electrocardiographic and biochemical adverse effects of sodium stibogluconate during treatment of cutaneous and mucosal leishmaniasis among returned travellers.
Armstrong, M; Chilton, D; Lawn, SD; Whitty, CJ, 2006
)
0.33
"A review of this adverse event resulted in five recommendations: (1) Provide staffing continuity among pharmacists and pharmacy technicians preparing and nurses administering the admixture; (2) Take time to ensure thorough and deliberative consideration ofquestions or concerns about admixture preparation; (3) Use due diligence in performing double checks of admixture calculations; (4) Know the drug and seek clarification when appropriate; and (5) Examine label information carefully."( Improving the safety of intravenous admixtures: lessons learned from a Pentostam overdose.
Just, S; Kauffman, CA; Piotrowski, MM; Saint, S; Schepers, G, 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
)
0.33
" The vaccine was safe and well tolerated, and induced both humoral and cell-mediated immune responses."( A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine when used in combination with sodium stibogluconate for the treatment of mucosal leishmaniasis.
Alves, FP; Ashman, JA; Beckmann, AM; Bertholet, S; Bogatzki, LY; Calderón, W; Coler, RN; Cowgill, KD; Cruz, M; Kahn, SJ; Laughlin, EM; Llanos-Cuentas, A; Piazza, FM; Reed, SG, 2010
)
0.36
" SbV has a side effect profile that requires treatment interruption in up to 28% of patients."( Glucocorticoids as a novel approach to the treatment of disabling side effects of sodium stibogluconate.
Brostoff, JM; Lockwood, DN, 2012
)
0.38
" These disturbances were temporary and did not result in adverse clinical events."( Monitoring toxicity associated with parenteral sodium stibogluconate in the day-case management of returned travellers with New World cutaneous leishmaniasis [corrected].
Armstrong, MS; Lockwood, DN; Watson, J; Wise, ES, 2012
)
0.38
" Combination regimens including AmBisome and miltefosine are safe and effective in India, but there are no published data from trials of combination therapies including these drugs from Africa."( Efficacy and Safety of AmBisome in Combination with Sodium Stibogluconate or Miltefosine and Miltefosine Monotherapy for African Visceral Leishmaniasis: Phase II Randomized Trial.
Alexander, N; Ali, MH; Alves, F; Balasegaram, M; Dorlo, TP; Edwards, T; Elamin, MY; Ellis, S; Hailu, A; Juma, R; Khalil, EA; Kimutai, R; Kip, AE; Kirigi, G; Musa, A; Musa, B; Njenga, S; Olobo, J; Omollo, R; Schoone, GJ; Strub Wourgaft, N; Wasunna, M; Wells, S, 2016
)
0.43
" VL patients treated using the new treatment were consented and included in a common registry that collected demographics, baseline clinical characteristics, adverse events, serious adverse events and treatment outcomes."( Safety and Effectiveness of Sodium Stibogluconate and Paromomycin Combination for the Treatment of Visceral Leishmaniasis in Eastern Africa: Results from a Pharmacovigilance Programme.
Alirol, E; Alvar, J; Alves, F; Balasegaram, M; Chappuis, F; Diro, E; Ellis, S; Hailu, A; Jameneh, A; Khalil, EA; Kimutai, R; Makonnen, E; Mohammed, R; Musa, AM; Musa, B; Njoroge, S; Okello, L; Olobo, J; Omollo, R; Rashid, J; Ritmeijer, K; Sagaki, P; Salman, K; Soipei, P; Strub, N; Wasunna, M, 2017
)
0.46
" SSG-PM was effective and safe except in HIV/VL co-infected or older patients."( Safety and Effectiveness of Sodium Stibogluconate and Paromomycin Combination for the Treatment of Visceral Leishmaniasis in Eastern Africa: Results from a Pharmacovigilance Programme.
Alirol, E; Alvar, J; Alves, F; Balasegaram, M; Chappuis, F; Diro, E; Ellis, S; Hailu, A; Jameneh, A; Khalil, EA; Kimutai, R; Makonnen, E; Mohammed, R; Musa, AM; Musa, B; Njoroge, S; Okello, L; Olobo, J; Omollo, R; Rashid, J; Ritmeijer, K; Sagaki, P; Salman, K; Soipei, P; Strub, N; Wasunna, M, 2017
)
0.46
" The most common adverse events (AEs) were raised liver transaminases (35."( Efficacy and safety of a combined treatment of sodium stibogluconate at 20mg/kg/day with upper maximum daily dose limit of 850mg and Paromomycin 15mg/kg/day in HIV negative visceral leishmaniasis patients. A retrospective study, northwest Ethiopia.
Atnafu, S; Hailu, A; Medhin, G; Mohammed, R; Tamiru, A, 2021
)
0.62
"A combination of SSG at 20mg/kg with upper daily maximum dose of 850mg and PM was effective for achieving initial cure at end of treatment and safe for treatment of HIV negative VL patients in northwestern Ethiopia."( Efficacy and safety of a combined treatment of sodium stibogluconate at 20mg/kg/day with upper maximum daily dose limit of 850mg and Paromomycin 15mg/kg/day in HIV negative visceral leishmaniasis patients. A retrospective study, northwest Ethiopia.
Atnafu, S; Hailu, A; Medhin, G; Mohammed, R; Tamiru, A, 2021
)
0.62

Pharmacokinetics

ExcerptReferenceRelevance
" Serum Sb declined with an initial half-life of 1 hr."( Pharmacokinetics of pentavalent antimony (Pentostam) in hamsters.
Berman, JD; Gallalee, JF; Gallalee, JV, 1988
)
0.27
" The pharmacokinetic parameters for the antimonial drug were calculated using a non-compartmental model."( Effect of renal impairment on the pharmacokinetics of antimony in hamsters.
Al-Jasser, M; Zaghloul, IY, 2004
)
0.32
" Blood samples were collected after the first or last doses, to allow the pharmacokinetic parameters of SbV after single and multiple dosing to be compared."( The effects of induced diabetes and cutaneous Leishmania infection on the pharmacokinetics of antimony in hamsters.
Al Jaser, MH; Al Rayes, ZR; Radwan, MA, 2007
)
0.34
" A population pharmacokinetic model was developed for paromomycin in Eastern African and Indian VL patients."( Geographical Variability in Paromomycin Pharmacokinetics Does Not Explain Efficacy Differences between Eastern African and Indian Visceral Leishmaniasis Patients.
Alves, F; Aman, R; Beijnen, JH; Chakravarty, J; Dorlo, TPC; Hailu, A; Hailu, W; Huitema, ADR; Hurissa, Z; Khalil, EAG; Kokwaro, G; Kshirsagar, SA; Makonnen, E; Mekonnen, Y; Mudawi, M; Musa, AM; Rai, M; Sundar, S; Tesfaye, S; Verrest, L; Wasunna, M; Younis, BM, 2021
)
0.62
"The developed model provides detailed insight into the pharmacokinetic differences among Eastern African countries and India, however the resulting differences in paromomycin exposure do not seem to explain the geographical differences in paromomycin efficacy in the treatment of VL patients."( Geographical Variability in Paromomycin Pharmacokinetics Does Not Explain Efficacy Differences between Eastern African and Indian Visceral Leishmaniasis Patients.
Alves, F; Aman, R; Beijnen, JH; Chakravarty, J; Dorlo, TPC; Hailu, A; Hailu, W; Huitema, ADR; Hurissa, Z; Khalil, EAG; Kokwaro, G; Kshirsagar, SA; Makonnen, E; Mekonnen, Y; Mudawi, M; Musa, AM; Rai, M; Sundar, S; Tesfaye, S; Verrest, L; Wasunna, M; Younis, BM, 2021
)
0.62

Compound-Compound Interactions

ExcerptReferenceRelevance
" The present study was designed to assess the effectiveness of parenteral aminosidine, alone or combined with sodium stibogluconate, in visceral leishmaniasis, compared to treatment by stibogluconate alone."( Treatment of visceral leishmaniasis in Kenya by aminosidine alone or combined with sodium stibogluconate.
Chunge, CN; Donno, L; Owate, J; Pamba, HO,
)
0.13
" In 2002, we replaced the standard regimen of 30 days of daily sodium stibogluconate (SSG) with a 17-day regimen of daily SSG combined with paromomycin (PM)."( Treatment of kala-azar in southern Sudan using a 17-day regimen of sodium stibogluconate combined with paromomycin: a retrospective comparison with 30-day sodium stibogluconate monotherapy.
Collin, SM; Davidson, RN; Gatluak, F; Keus, K; Melaku, Y; Ritmeijer, K, 2007
)
0.34
"This study compares the efficacy of intralesional SSG given alone with that of intralesional SSG combined with intramuscular SSG."( Comparative efficacy of intralesional sodium stibogluconate (SSG) alone and its combination with intramuscular SSG to treat localized cutaneous leishmaniasis: Results of a pilot study.
Kanga, AK; Mahajan, VK; Negi, AK; Ranjan, N; Sharma, NL,
)
0.13
"Intralesional combined with intramuscular SSG appears more effective in LCL and gave qualitatively superior healing than intralesional SSG given alone."( Comparative efficacy of intralesional sodium stibogluconate (SSG) alone and its combination with intramuscular SSG to treat localized cutaneous leishmaniasis: Results of a pilot study.
Kanga, AK; Mahajan, VK; Negi, AK; Ranjan, N; Sharma, NL,
)
0.13
" Oral ketoconazole is much easier and safer therapy than intramuscular SSG in combination with intralesional SSG in the treatment of localized cutaneous leishmaniasis."( Intralesional sodium stibogluconate alone or its combination with either intramuscular sodium stibogluconate or oral ketoconazole in the treatment of localized cutaneous leishmaniasis: a comparative study.
Anwar, AE; El-Sayed, M, 2010
)
0.36
" Levels of SHP-1 substrates (pSTAT1, pSTAT3, pLck and pSlp76) were increased (up to 3x) in peripheral blood cells following SSG with no potentiation by combination with IFN-α2b."( Phosphatase inhibitor, sodium stibogluconate, in combination with interferon (IFN) alpha 2b: phase I trials to identify pharmacodynamic and clinical effects.
Borden, EC; Budd, TG; Elson, P; Hollovary, E; Jacobs, B; Mitsuhashi, M; Spiro, T; Triozzi, P; Yi, T, 2011
)
0.37

Bioavailability

ExcerptReferenceRelevance
"Antileishmanial chemotherapy is hampered by the location of the parasite within the phagolysosome of the macrophage, which restricts the bioavailability of many potentially useful antileishmanial drugs."( Antileishmanial drug targeting through glycosylated polymers specifically internalized by macrophage membrane lectins.
Chance, ML; Hanboula, SY; Hommel, M; Mayer, RM; Monsigny, M; Nègre, E; Roche, AC, 1992
)
0.28
" In vivo effectiveness may depend on bioavailability of Sb in the host and the direct action on the parasite, reflected by its in vitro activity."( Antitrypanosomal activity of trivalent antimonials in vitro and its significance.
Ercoli, N; Minelli, EB; Olivo, N, 1980
)
0.26
"Impairment of both synthesis and uptake of NO resulted in decreased bioavailability of this signaling molecule in erythrocytes in VL."( Regulatory role of nitric oxide in the reduced survival of erythrocytes in visceral leishmaniasis.
Biswas, T; Chowdhury, KD; Sen, G, 2010
)
0.36

Dosage Studied

ExcerptRelevanceReference
" The drug was administered either intramuscularly at a dosage of 6 ml daily for at least 10 days or infiltrated around the lesion (maximum 2 ml per lesion) at weekly intervals for 3 to 4 consecutive weeks."( Evaluation of sodium stibogluconate in the treatment of cutaneous leishmaniasis in Syria.
Ghosn, S, 1979
)
0.26
" As dosage regimens for treating leishmaniasis have evolved, the daily dose of antimony and the duration of therapy have been progressively increased to combat unresponsiveness to therapy."( Recommendations for treating leishmaniasis with sodium stibogluconate (Pentostam) and review of pertinent clinical studies.
Berman, JD; Herwaldt, BL, 1992
)
0.28
" Only one therapy, multiple dosing with drug loaded sonicated vesicles, liposomes or niosomes, was found to be effective against parasites in the liver, spleen and bone marrow."( Visceral leishmaniasis: drug carrier system characteristics and the ability to clear parasites from the liver, spleen and bone marrow in Leishmania donovani infected BALB/c mice.
Alexander, J; Baillie, AJ; Carter, KC; Dolan, TF; McColgan, C, 1989
)
0.28
" Na-Stibogluconate (Pentostam) was used for the treatment at a dosage of 10 or 20 mg/kg on 10 or 14 consecutive days."( [Imported leishmaniasis of dogs: clinical aspects, diagnosis and therapy with Na stibogluconate (Pentostam)].
Reiter, I; Reusch, C, 1987
)
0.27
" Sodium stibogluconate should be given intramuscularly in the dosage of 20 mg/kg for at least 40 days, when patients should be assessed for further treatment if necessary."( Rationalisation of regimens of treatment of kala-azar with sodium stibogluconate in India: a randomised study.
Kumar, M; Kumar, P; Mishra, BN; Pandey, AK; Thakur, CP, 1988
)
0.27
" The generally comparable levels of Sb in the skin and in the visceral organs support the present clinical practice of administering the same dosage of Sb for cutaneous and visceral leishmaniasis."( Pharmacokinetics of pentavalent antimony (Pentostam) in hamsters.
Berman, JD; Gallalee, JF; Gallalee, JV, 1988
)
0.27
" If shorter courses are ineffective prolonged and continued courses may be given provided that renal function is assessed and the dosage is adjusted when indicated."( Renal clearance of pentavalent antimony (sodium stibogluconate).
Hockmeyer, WT; Kager, PA; Keating, MI; Rees, PH, 1980
)
0.26
"A prospective randomized trial of three dosage regimens of sodium stibogluconate (Pentostam; Wellcome Foundation, London) to treat visceral leishmaniasis was conducted."( A comparison of three dosage regimens of sodium stibogluconate in the treatment of visceral leishmaniasis in Kenya.
Bhatt, SM; Bryceson, AD; Chulay, JD; Chunge, C; Gachihi, G; Ho, M; Muigai, R; Were, JB, 1983
)
0.27
" Blood samples were taken at various times after dosing and antimony levels in various tissues were determined at 3 h, 48 h and 6 days after dosing."( The distribution of free and non-ionic vesicular sodium stibogluconate in the dog.
Baillie, AJ; Carter, KC; Collins, M; O'Grady, J, 1993
)
0.29
" orally in divided dosage for 30 days."( Combination therapy in Kala-azar.
Jha, S; Jha, TK; Singh, IJ; Singh, NK, 1995
)
0.29
" Dose-response curve analyses show that Leishmania promastigotes are susceptible to Pentostam, with the 50% inhibitory concentration (IC50) being 104 microg/ml, while amastigotes are more susceptible, with the IC50 being 24 microg/ml."( Pentostam induces resistance to antimony and the preservative chlorocresol in Leishmania donovani promastigotes and axenically grown amastigotes.
Ephros, M; Waldman, E; Zilberstein, D, 1997
)
0.3
" Results of the study show that treatment of cases of Kala-azar with sodium stibogluconate in a dosage of 20 mg/kg/day for a longer period of 30 days is effective with a higher cure rate and minimum side effects, for treatment of cases of Kala-azar in this eastern part of Nepal, endemic for the disease."( A thirty day course of sodium stibogluconate for treatment of Kala-azar in Nepal.
Das, ML; Hansdak, SG; Karki, P; Koirala, S; Parija, SC, 1998
)
0.3
"The efficacy and toxicity of sodium stibogluconate (SSG) at a dosage of 20 mg/(kg."( Safety and efficacy of intravenous sodium stibogluconate in the treatment of leishmaniasis: recent U.S. military experience.
Aronson, NE; Beard, JS; Benson, PM; Coyne, PE; Endy, TP; Gambel, JM; Gasser, RA; Grogl, M; Jackson, JE; Johnson, SC; Kreutzer, RD; Magill, AJ; Oster, CN; Tally, JD; Wortmann, GW, 1998
)
0.3
" 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
"The recommended treatment for cutaneous leishmaniasis is pentavalent antimony at a dosage of 20 mg/kg/day for 20 days."( A randomized, double-blind study of the efficacy of a 10- or 20-day course of sodium stibogluconate for treatment of cutaneous leishmaniasis in United States military personnel.
Aronson, N; Jackson, J; Miller, RS; Oster, C; Wortmann, G, 2002
)
0.31
" Therapy was discontinued until the transaminase values normalized, then continued in reduced dosage (12 mg/kg body weight) for 23 days."( [American cutaneous leishmaniasis: special features in diagnosis and therapy].
Bormann, G; Gaber, G; Marsch, W; Schulz, A; William, T, 2003
)
0.32
" Also, nurses and pharmacists had less than adequate information about new or unusually dosed medications."( Improving the safety of intravenous admixtures: lessons learned from a Pentostam overdose.
Just, S; Kauffman, CA; Piotrowski, MM; Saint, S; Schepers, G, 2006
)
0.33
" This modulatory effect was dosage dependent and not observed in apigenin monomers with the linker, suggesting that the modulatory effect is due to its bivalent nature."( Flavonoid dimers as bivalent modulators for pentamidine and sodium stiboglucanate resistance in leishmania.
Burkett, BA; Chai, Y; Chan, KF; Chan, TH; Chow, LM; Sun, H; Wong, IL; Zhao, Y, 2007
)
0.34
" Blood samples were collected after the first or last doses, to allow the pharmacokinetic parameters of SbV after single and multiple dosing to be compared."( The effects of induced diabetes and cutaneous Leishmania infection on the pharmacokinetics of antimony in hamsters.
Al Jaser, MH; Al Rayes, ZR; Radwan, MA, 2007
)
0.34
" SAG was used at a dosage of 20 mg/kg given deep intramuscular injections in buttock for 28 days, amphotericin B (AMB) given at a dose of 1 mg/kg body wt daily for 20 days as a slow intravenous infusion in 5 per cent dextrose."( Comparison of treatment regimens of kala-azar based on culture & sensitivity of amastigotes to sodium antimony gluconate.
Narayan, S; Sinha, A; Thakur, CP; Thakur, S, 2008
)
0.35
" After treatment with an increasing drug dosage for 7 days, acute renal injury was evident as indicated by increased serum creatinine and urea nitrogen."( Case report: Acute renal injury as a result of liposomal amphotericin B treatment in sodium stibogluconate unresponsive visceral leishmaniasis.
Li, L; Mao, Q; Zhang, D; Zhao, S, 2011
)
0.37
" Allometric dosing of miltefosine in children needs to be evaluated."( Efficacy and Safety of AmBisome in Combination with Sodium Stibogluconate or Miltefosine and Miltefosine Monotherapy for African Visceral Leishmaniasis: Phase II Randomized Trial.
Alexander, N; Ali, MH; Alves, F; Balasegaram, M; Dorlo, TP; Edwards, T; Elamin, MY; Ellis, S; Hailu, A; Juma, R; Khalil, EA; Kimutai, R; Kip, AE; Kirigi, G; Musa, A; Musa, B; Njenga, S; Olobo, J; Omollo, R; Schoone, GJ; Strub Wourgaft, N; Wasunna, M; Wells, S, 2016
)
0.43
" Allometric dosing ensured similar MF exposure in children (<12 years) and adults."( Paromomycin and Miltefosine Combination as an Alternative to Treat Patients With Visceral Leishmaniasis in Eastern Africa: A Randomized, Controlled, Multicountry Trial.
Alcoba, G; Alvar, J; Alves, F; Dorlo, TPC; Egondi, T; Fikre, H; Ismail Omer Haroun, A; Khalil, EAG; Mbui, J; Mekonnen, T; Mersha, D; Mohammed, R; Musa Younis, B; Musa, AM; Muthoni Ouattara, G; Nakanwagi, P; Njenga, S; Nour, A; Olobo, J; Omollo, T; Ritmeijer, K; Sagaki, P; Sisay, K; Solomos, A; Taha Ahmed Elmukashfi, E; Verrest, L; Wasunna, M, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (815)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990199 (24.42)18.7374
1990's207 (25.40)18.2507
2000's213 (26.13)29.6817
2010's163 (20.00)24.3611
2020's33 (4.05)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials94 (10.34%)5.53%
Reviews60 (6.60%)6.00%
Case Studies221 (24.31%)4.05%
Observational1 (0.11%)0.25%
Other533 (58.64%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (21)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Efficacy of Intralesional Voriconazole Versus Intralesional Cryotherapy Versus Intralesional Sodium Stibogluconate Versus Oral Doxycycline in the Treatment of Acute Cutaneous Leishmaniasis [NCT05708625]Phase 3136 participants (Anticipated)Interventional2022-01-01Recruiting
A Randomized, Open-label, Phase II, Single-centre Study to Evaluate the Efficacy, Safety and Pharmacokinetics of LXE408 in Patients With Primary Visceral Leishmaniasis in Ethiopia [NCT05957978]Phase 252 participants (Anticipated)Interventional2024-01-31Not yet recruiting
A Multicentre Observational Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis [NCT04342715]280 participants (Anticipated)Observational2022-05-22Recruiting
An Open Label, Phase III, Randomized Controlled, Multicentre Non-Inferiority Trial to Compare Efficacy and Safety of Miltefosine and Paromomycin With SSG and PM Combination for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa [NCT03129646]Phase 3439 participants (Actual)Interventional2018-01-24Completed
Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients [NCT02281669]100 participants (Anticipated)Observational2014-11-30Not yet recruiting
SHP2 as a Therapeutic Target For Myelodysplastic Syndrome: Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome [NCT01009502]Phase 11 participants (Actual)Interventional2009-07-31Terminated(stopped due to Lack of funding, never moved into the phase II portion that was originally planned.)
A Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine in the Treatment of Patients With Cutaneous Leishmaniasis [NCT01011309]Phase 245 participants (Actual)Interventional2009-10-31Completed
A Phase I/II Randomized Comparison of Localized Heat Therapy Versus Sodium Stibogluconate (Pentostam) for the Treatment of Old World Cutaneous Leishmaniasis (HSRRB Log No. A-12364) [NCT00884377]Phase 256 participants (Actual)Interventional2004-02-29Completed
Sodium Stibogluconate Treatment of Leishmaniasis [NCT00662012]Phase 2414 participants (Actual)Interventional2002-06-30Completed
A Phase II Randomized, Parallel Arm, Open-labeled Clinical Trial to Assess the Safety and Efficacy of the Combination of Sodium Stibogluconate Plus Single Dose AmBisome®, Miltefosine Plus Single Dose AmBisome® and Miltefosine Alone for the Treatment of Pr [NCT01067443]Phase 2151 participants (Actual)Interventional2010-03-31Completed
Department of Defense Protocol for the Use of Sodium Stibogluconate (Pentostam) as a Treatment for Leishmaniasis [NCT00657618]Phase 1/Phase 277 participants (Actual)Interventional2004-10-31Completed
Phase II Open Randomized Clinical & Health Economic Trial Comparing Intralesional Antimony Therapy Versus Wound Care Management in Old World Cutaneous Leishmaniasis Patients in Northern Afghanistan [NCT00996463]Phase 263 participants (Anticipated)Interventional2010-01-31Completed
A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sodium Stibogluconate in Combination With Interferon Alpha-2b for Patients With Advanced Malignancies [NCT00629200]Phase 133 participants (Actual)Interventional2006-09-13Completed
Phase I Evaluation of Sodium Stibogluconate in Combination With Interferon α-2b Followed by Cisplatin, Vinblastine and Dacarbazine for Patients With Melanoma or Malignancies Potentially Responsive to SSG and/or Interferons [NCT00498979]Phase 122 participants (Actual)Interventional2007-05-31Completed
Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis [NCT00508963]0 participants Expanded AccessNo longer available
A Multicentre Comparative Trial of Efficacy and Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) Versus Combination of SSG and PM as the First Line Treatment for Visceral Leishmaniasis in Ethiopia, Kenya and Sudan [NCT00255567]Phase 31,142 participants (Actual)Interventional2004-11-30Completed
Phase I Evaluation of Sodium Stibogluconate in Combination With Interferon α-2b for Solid Tumors, Lymphoma or Myeloma [NCT00311558]Phase 118 participants (Actual)Interventional2005-10-31Terminated
An Open Label Study of RFH Therapy as Treatment for CL Caused by Leishmania Tropica in India [NCT01661296]Phase 4100 participants (Actual)Interventional2009-08-31Completed
[NCT03009422]20 participants (Actual)Interventional2014-11-30Active, not recruiting
Documentation of Patient Outcomes for the Combination Treatment of Sodium Stibogluconate and Allopurinol in Complicated Cutaneous Leishmaniasis in Ethiopia [NCT04699383]105 participants (Actual)Observational2021-02-15Completed
Sodium Stibogluconate in the Myelodysplastic Syndromes/Acute Myeloid Leukemia With One of the 65 Defined p53 Mutations That Can be Functionally Rescued by Sodium Stibogluconate [NCT04906031]Phase 25 participants (Anticipated)Interventional2020-06-01Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00657618 (2) [back to overview]Number of Participants Experiencing Serious or Unexpected Adverse Events, by Type of Serious or Unexpected Adverse Events
NCT00657618 (2) [back to overview]Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience
NCT00662012 (2) [back to overview]Improvement of Lesions, Resolution of Fever and Lab Abnormalities for Visceral Leishmaniasis and Regression of Mucosal Lesions .
NCT00662012 (2) [back to overview]The Primary Safety Endpoint - Frequency of Complications of Therapy
NCT00884377 (6) [back to overview]Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure
NCT00884377 (6) [back to overview]Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure
NCT00884377 (6) [back to overview]Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
NCT00884377 (6) [back to overview]Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments
NCT00884377 (6) [back to overview]Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments
NCT00884377 (6) [back to overview]Number of Participants With Solicited Adverse Events
NCT01011309 (3) [back to overview]Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.
NCT01011309 (3) [back to overview]Date of Clinical Cure
NCT01011309 (3) [back to overview]IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)

Number of Participants Experiencing Serious or Unexpected Adverse Events, by Type of Serious or Unexpected Adverse Events

The safety of Pentostam (SSG) treatment was evaluated through the daily assessment of AEs during treatment. Additionally, clinical laboratory tests including serum chemistry (glucose, electrolytes, blood urea nitrogen [BUN], creatinine, alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin, alkaline phosphatase [ALK], amylase, and lipase) and hematology (hemoglobin, hematocrit, platelets, and white blood cells with differential); vital signs measurements; electrocardiograms (ECGs); and physical examinations were performed at screening and prior to Pentostam infusion on Days (± 2) 5, 10, 15, 20, 25, and 28 (Days 25 and 28 for patients with visceral or mucocutaneous leishmaniasis only). At the completion of Pentostam treatment, patients were encouraged to arrange follow-up at 2, 6, and 12 months after treatment; however, follow-up was not required. (NCT00657618)
Timeframe: prior to infusion on days 2) 5, 10, 15, 20, 25, and 28

InterventionParticipants (Count of Participants)
Elevated lipase levelChemical hepatitisAllergic reaction with atypical presentationMisdiagnosisAllergic reactionHospitalized for unhealed cutaneous lesion
Treatment Only411111

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Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience

The safety of Pentostam (SSG) treatment was evaluated through the daily assessment of AEs during treatment. Additionally, clinical laboratory tests including serum chemistry (glucose, electrolytes, blood urea nitrogen [BUN], creatinine, alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin, alkaline phosphatase [ALK], amylase, and lipase) and hematology (hemoglobin, hematocrit, platelets, and white blood cells with differential); vital signs measurements; electrocardiograms (ECGs); and physical examinations were performed at screening and prior to Pentostam infusion on Days (± 2) 5, 10, 15, 20, 25, and 28 (Days 25 and 28 for patients with visceral or mucocutaneous leishmaniasis only). At the completion of Pentostam treatment, patients were encouraged to arrange follow-up at 2, 6, and 12 months after treatment; however, follow-up was not required. (NCT00657618)
Timeframe: prior to infusion on days (± 2) 5, 10, 15, 20, 25, and 28

InterventionParticipants (Count of Participants)
Myalgia/arthralgiaElevated liver-associated enzymesRashSubtle elevation of amylase and lipaseMisdiagnosisDecreased white blood cell countNephrotoxicityChemical pancresatitisDrug reaction
Treatment Only12103111111

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Improvement of Lesions, Resolution of Fever and Lab Abnormalities for Visceral Leishmaniasis and Regression of Mucosal Lesions .

Improvement of lesions for cutaneous leishmanias, resolution of fever and lab abnormalities for visceral leishmaniasis and regression of mucosal lesions for mucocutaneous disease. (NCT00662012)
Timeframe: 5 years

Interventionparticipants (Number)
SSG 20 mg/kg414

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The Primary Safety Endpoint - Frequency of Complications of Therapy

The primary safety endpoint is the frequency of complications of therapy (NCT00662012)
Timeframe: 5 years

Interventionparticipants (Number)
SSG 20 mg/kg414

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Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure

"Determine the equivalence of efficacy (clinical cure) of ThermoMed treatment vs sodium stibogluconate in clinical response of all skin lesions at 12 months. Clinical cure is defined as complete epithelialization of lesion. Post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, clinical response was assessed by lesion and by subject. In addition, an overall response was assigned (healed or not healed) based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test." (NCT00884377)
Timeframe: 12 months

,
InterventionParticipants (Count of Participants)
HealedNot HealedNot ApplicableClincally CuredNot Clinically CuredNot Evaluable
Sodium Stibogluconate25212323
ThermoMed Device23412125

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Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure

"Assess whether local heat therapy using the ThermoMed device was equivalent (clinical cure) in efficacy to 10 days of parenteral sodium stibogluconate. Clinical cure is defined as complete epithelialization of lesion. post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, clinical response was assessed by lesion and by subject. In addition, an overall response was assigned (healed or not healed) based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test." (NCT00884377)
Timeframe: Assessment of cure is made at 2 months after treatment

,
InterventionParticipants (Count of Participants)
HealedNot HealedNot ApplicableCuredNot CuredNot Evaluable
Sodium Stibogluconate225113132
ThermoMed Device189111143

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Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial

Evaluate the feasibility of using species-specific PCR as a rapid diagnostic assay for L. major infection. The comparator modalities were: histopathology (identification of amastigotes); speciation determined through culture and isoenzyme analysis; and genus and species-specific PCR. Species PCR testing was performed at baseline to allow for the identification of L. major as each subject's infecting parasite. If an L. major infection could not be confirmed in a subject's lesion(s), then that subject could not be treated under this protocol. (NCT00884377)
Timeframe: at baseline before treatment

,
InterventionParticipants (Count of Participants)
Histopathology: Amastigotes absentHistopathology: Amastigotes presentCulture: Not doneCulture: UnknownCulture: NegativeCulture: PositiveCulture/Isoenzyme Analysis: L.major = PositiveCulture/Isoenzyme analysis: Unknown Leish speciesCulture/Isoenzyme analysis: Not donePCR (Genus) = Positive for Leish genusPCR (Species) = Positive for L.major speciesPCR (Species) = Unknown
Sodium Stibogluconate101840618122428271
ThermoMed Device62251418123428280

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Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments

Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns. (NCT00884377)
Timeframe: day 1 and day 10

,,,
Intervention% of T-cells (Mean)
CD3+CD8 (%)CD19 (%)CD16+CD56 (%)
Study Day 1: Sodium Stibogluconate25.0717.969.67
Study Day 1: ThermoMed25.6715.309.81
Study Day 10: Sodium Stibogluconate26.5416.7310.73
Study Day 10: ThermoMed26.8515.1111.74

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Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments

Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns. (NCT00884377)
Timeframe: day 1 and day 10

,,,
Interventionpopulations of T-cells (Mean)
ABS CD3+CD8 (cells/uL)ABS CD19 (cells/uL)ABS CD16+CD56 (cells/uL)
Study Day 1: Sodium Stibogluconate515.89375.37196.52
Study Day 1: ThermoMed368.74213.85137.74
Study Day 10: Sodium Stibogluconate534.19328.27207.62
Study Day 10: ThermoMed500.15274.70221.96

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Number of Participants With Solicited Adverse Events

To compare the toxicity profiles of ThermoMed treatment versus parenteral sodium stibogluconate therapy thru specific solicited adverse events (NCT00884377)
Timeframe: Days 3, 7 and 10

,
Interventionsubjects showing specified symptoms (Number)
Myalgias : Day 3Myalgias : Day 7Myalgias : Day 10Arthralgias : Day 3Arthralgias : Day 7Arthralgias : Day 10Nausea : Day 3Nausea : Day 7Nausea : Day 10Vomiting : Day 3Vomiting : Day 7Vomiting : Day 10Abdominal Pain : Day 3Abdominal Pain : Day 7Abdominal Pain : Day 10Headache : Day 3Headache : Day 7Headache : Day 10Diarrhea : Day 3Diarrhea : Day 7Diarrhea : Day 10Rash : Day 3Rash : Day 7Rash : Day 10Fever : Day 3Fever : Day 7Fever : Day 10Fatigue : Day 3Fatigue : Day 7Fatigue : Day 10Chest Pain : Day 3Chest Pain : Day 7Chest Pain : Day 10Other : Day 3Other : Day 7Other : Day 10
Sodium Stibogluconate435411734112023279523322302017119100362
ThermoMed Treatment100222101000001222101101000313000257

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Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.

Safety of immunotherapy with the vaccine was compared to the safety of chemotherapy with sodium stibogluconate. All adverse events are listed regardless of relatedness. (NCT01011309)
Timeframe: Day 0 through Day 84

,,
Interventionparticipants (Number)
Injection site erythemaInjection site indurationInjection site painSuperinfection bacterialALT increasedAlkaline phosphatase increasedTotal bilirubin increasedHemoglobin decreasedWBC decreasedHeadacheNausea
Chemotherapy0000101371053
Immunotherapy v1.4/1.5108848543430
Immunotherapy v1.69101004110130

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Date of Clinical Cure

Efficacy of immunotherapy with the LEISH-F2 + MPL-SE vaccine was compared to the efficacy of chemotherapy with sodium stibogluconate in the treatment of CL. Efficacy is measured by the date of clinical cure. (NCT01011309)
Timeframe: Day 84

,,
Interventionparticipants (Number)
Clinical cure by Day 84 without rescue treatmentClinical cure by Day 84 with rescue treatment
Chemotherapy151
Immunotherapy v1.4/1.5210
Immunotherapy v1.625

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IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)

Immunogenicity of the vaccine was evaluated by measuring IgG antibody and T-cell responses to the LEISH-F2 protein and soluble Leishmania antigen (SLA). IgG antibodies were measured by ELISA and T-cell cytokine responses (IFN-g and IL-10) were measured by Luminex. Data is presented as median Post:Pre ratios comparing Days 56/84 or 168 to baseline at Day 0. (NCT01011309)
Timeframe: Days 0, 56 or 84, and 168

,,
InterventionRelative ELISA Units (Median)
IgG antibody to LEISH-F2 - Day 56IgG antibody to LEISH-F2 - Day 84IgG antibody to LEISH-F2 - Day 168IgG antibody to SLA - Day 56IgG antibody to SLA - Day 84IgG antibody to SLA - Day 168IFN-g response to LEISH-F2 - Day 56IFN-g response to LEISH-F2 - Day 84IFN-g response to LEISH-F2 - Day 168IFN-g response to SLA - Day 56IFN-g response to SLA - Day 84IFN-g response to SLA - Day 168IL-10 response to LEISH-F2 - Day 56IL-10 response to LEISH-F2 - Day 84IL-10 response to LEISH-F2 - Day 168IL-10 response to SLA - Day 56IL-10 response to SLA - Day 84IL-10 response to SLA - Day 168
Chemotherapy2.0040.6620.740.590.540.331.091.3330.820.840.890.691.221.171.030.690.920.763
Immunotherapy v1.4/1.5NA76.7223.93NA1.60.63NA0.921.00NA0.270.2NA1.442.19NA0.630.952
Immunotherapy v1.684.56NA10.261.36NA0.954.97NA2.060.87NA0.313.16NA0.91.02NA0.565

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