A Phase 3 interventional study of Group 1: Miltefosine and Group 2: Pentavalent Antimony in Mucosal Leishmaniasis, sponsored by Fundacion Nacional de Dermatologia. Recruiting at 1 site in Bolivia. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Fundacion Nacional de Dermatologia · Phase 3, Interventional, and Treatment
The purpose of this protocol is to conduct a randomized comparison of the efficacy and tolerance of miltefosine, LAMB, and pentavalent antimony for the treatment of mucosal leishmaniasis. With such controlled pharmacodynamic data, and additional considerations of administrative convenience (oral >>IV) and cost, we hope that it will be possible for policy makers, treatment professionals, and patients to choose the most appropriate therapy for ML.
21 studies on the registry are indexed under Leishmaniasis, Mucocutaneous; 7 are open to participants now.
This study's planned enrollment of 120 is above the median of 49 across 16 interventional studies indexed under Leishmaniasis, Mucocutaneous.
Browse Leishmaniasis, Mucocutaneous studies →Fundacion Nacional de Dermatologia is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Miltefosine will be administered per os at 150 mg/day \[50 mg tid\] for 28 days. This is the standard regimen of miltefosine for persons \>45 kg.
Drug: Group 1: Miltefosine
IV pentavalent antimony (meglumine antimoniate) will be administrated at 20 mg x kg x d during 20 consecutive days. Antimony will be diluted in 10 times its volume in 5%Dextrose in destilled water and injected IV in 20 minutes
Drug: Group 2: Pentavalent Antimony
LAMB will be administered IV at 3 ampules \[150 mg\] on each of days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27. Three ampules is the individual dose suggested by Aronson et al \[2016\] and equals 2.5 mg/kg/dose for a 60 kg person. 15 doses of 3 ampules (total of 2250 mg) equals 37.5 mg/kg for a 60 kg person.
Drug: Group 3: Liposomal amphotericin B
Miltefosine 50 mg pill will be administered po every 8 hours with food, during 28 days
will be administered by IV infusion diluted in 150 ml of DWD5% over 20 minutes
3 amps (150 mg) will be administered by IV infusion iver 2 hours every other day for a total of 15 doses.
Healing of mucosal lesions
The primary purpose is to perform a controlled evaluation of the cure rate of miltefosine, LAMB, and Sb for L braziliensis ML in Bolivia. Using a standarized scale we'll qualify from 0 (absent) to 3 (severe) the following items: erythema, edema/swelling, infiltration, erosion/ulceration, in five different places: nasal and perinasal skin, nasal mucosa, palate and oral mucosa, pharynx and larynx. Additionally, changes in voice quality will be registered. 63 will be the maximun score and means severe and massive compromise. clinical cure: \>90% loss of presenting severity score clinical improvement: 50%-90% loss of presenting severity score no clinical change: 25% worsening to 49% improvement in presenting severity score clinically worse: \>25% worsening of presenting score or relapse after initial improvement
Time frame: Baseline to 12 month follow up
Clinical and laboratory safety of these 3 drugs
The secondary purpose is to determine the tolerance of these regimens. Descriptive statistics will be used to present adverse event data. Continuous variables will be presented as number of observations (n), mean, standard deviation (SD), median, minimum and maximum values. Categorical variables will be presented as counts and percentages. Adverse effects will be compared between groups by appropriate statistics. During treatment administration clinical symptoms (nausea/vomit/abdominal pain; myalgias/arthralgias; headache/dizziness) and laboratory (AST, alkaline phosphatase, lipase, creatinine, CBC) and EKG (in patients receiving antomony) will be evaluated.
Time frame: Base line to 1 month after the end of therapy
Started Apr 2021 (actual). Primary completion is estimated for Apr 2024, 36 months after the start.
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Studies of the drug tested here: Liposomal amphotericin B
Leishmaniasis, Mucocutaneous →
Fundacion Nacional de Dermatologia