A Phase 3 interventional study of Sodium Stibogluconate (SSG) and Miltefosine in Cutaneous Leihmaniasis, sponsored by Institute of Tropical Medicine, Belgium. Not yet recruiting at 3 sites in Ethiopia. Open to participants aged 4 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Institute of Tropical Medicine, Belgium · Phase 3, Interventional, and Treatment
MAMS4CL comprises a clinical trial with three embedded sub-studies designed to comprehensively evaluate the administered treatments and assess the impact of CL treatment on patients and the healthcare system.
The multi-centre multi-arm multi-stage phase 3 clinical trial is designed to rigorously evaluate a total of 4 alternative treatment options for systemic CL against Sodium Stibugluconate (SSG) as the standard of care. The trial comprises two seamlessly linked stages. In stage 1, all four investigational arms will be evaluated against the control arm for efficacy to inform the selection of the arms, based on a pre-defined efficacy threshold that will advance to stage 2, in addition to the control arm. After stage 2, the experimental interventions will be compared with SSG similar to a standard superiority trial for efficacy. The general study design in stage 1 and stage 2 will be identical; only the number of investigational arms may differ.
Patients will be randomized into the respective treatment arms at the recruitment sites of Arba Minch hospital, Boru Meda hospital and ALERT hospital in Ethiopia. Individuals will be hospitalized during the entire course of their treatment. As different arms have different treatment duration, patient hospitalization period and visit schedules will differ between arms. In total, the study will last 180 days for each participant.
103 studies on the registry are indexed under Leishmaniasis, Cutaneous; 18 are open to participants now.
This study's planned enrollment of 900 is above the median of 60 across 77 interventional studies indexed under Leishmaniasis, Cutaneous.
Browse Leishmaniasis, Cutaneous studies →Institute of Tropical Medicine, Belgium is the lead sponsor of 104 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard of Care: Sodium Stibogluconate
Drug: Sodium Stibogluconate (SSG)
Miltefosine
Drug: Miltefosine
Miltefosine + Paromomycin
Drug: Miltefosine + Paromomycin
Liposomal amphotericin B
Drug: Liposomal Amphotericin B (LAmB)
Pentamidine isethionate
Drug: Pentamidine isethionate
Intramuscular Administration - once daily for 28 days
Miltefosine - Oral Administration, daily for 28 days
Drug pages: Miltefosine · Paromomycin
Miltefosine - Oral Administration, daily for 28 days + Paromomycine - Intramuscular Administration, once daily for 14 days
Intravenous Administration, once daily on days 1, 3, 5, 7, 10, 12, 14, 17, 19, 21
Intravenous Administration - once daily on days 1, 3, 5, 7, 9, 11, 13
For each of the investigational arms (miltefosine/miltefosine + paromomycin / liposomal amphotericin B/pentamidine isethionate), to determine whether it has superior efficacy to the control arm in terms of achieving cure of all lesions at Day 90
Cure of all lesions at Day 90, pairwise compared between the control arm and each of the investigational arms. Cure at the lesion level is defined as 100% improvement of the area of erythema, induration, and ulceration of a lesion compared to the baseline assessment. Cure at the patient level is defined as cure of all lesions present at baseline, and no new lesions appearing. Cure is assessed at multiple timepoints, including Day 90. Cure at Day 90 is defined as cure assessed at Day 90, or cure assessed at the latest available time point before Day 90, without relapse (known as last observation carried forward (LOCF)).
Time frame: Day 90
For each investigational arm, to determine whether it has superior efficacy to the control arm, in terms of achieving cure of all lesions at Day 180.
Cure of all lesions at Day 180, pairwise compared between the control arm and each of the investigational arms . Cure at Day 180 is defined as cure assessed at Day 180, or cure assessed at the latest available timepoint before Day 180, without relapse (LOCF).
Time frame: Day 180
To compare between the control arm and each of the investigational arms: proportion of participants with all lesions cured, cure for all lesions considered individually, the proportion of participants whose index lesion is cured.
Cure at End of Treatment, Day 42, Day 90, and Day 180 at the patient and lesion level. 1. Cure of all lesions (patient level) at EoT and D42, pairwise compared between each of the investigational arms and the control arm. 2. Cure at End of Treatment, Day 42, Day 90, and Day 180, at the lesion level, adjusted for patient level, pairwise compared between each of the investigational arms and the control arm. 3. Cure of the index lesion at End of Treatment, Day 42, Day 90, and Day 180, pairwise compared between each of the investigational arms and the control arm.
Time frame: End of Treatment, Day 42, Day 90 and Day 180
To compare between the control arm and each of the investigational arms: proportion of participants that reach at least substantial improvement of all lesions and the index lesion + at least substantial improvement for all lesions individually,
Substantial improvement at participants and lesion level at End of Treatment, Day 42, Day 90, and Day 180 is defined as ≥50%-99% improvement of the area of erythema, induration, and ulceration, compared to the baseline assessment. Substantial improvement at a specific timepoint is defined as substantial improvement assessed at that timepoint, or at the latest available earlier timepoint. At least substantial improvement is defined as substantial improvement or cure. 1. At least substantial improvement of all lesions (patient level) at EoT, D42, D90, and D180, pairwise compared between each of the investigational arms and the control arm. 2. At least substantial improvement at EoT, D42, D90, and D180 at the lesion level, adjusted for patient level, pairwise compared between each of the investigational arms and the control arm. 3. At least substantial improvement of the index lesion at EoT, D42, D90, and D180, pairwise compared between each of the investigational arms and control arm.
Time frame: End of Treatment, Day 42, Day 90, Day 180
To compare between the control arm and each of the investigational arms, the proportion of participants with treatment failure at Day 42, Day 90, and Day 180.
Treatment failure at Day 42, Day 90, and Day 180. Treatment failure is defined as having the study treatment suspended for any reason as described in section 4.7.2, as having no improvement compared to baseline at Day 42, as having \<50% improvement compared to baseline at Day 90, as having anything but all lesions cured at Day 180, or as having worsening of lesions or new lesions compared to the previous visit.
Time frame: Day 42, Day 90, Day 180
To assess safety by describing safety & tolerability of each arm by listing number, proportion & severity of AEs/Comparing number, proportion & reason of withdrawals and number & proportion of patients with SAEs between control and investigational arm
Assessment of safety by: 1. Number and proportion, type, and severity of adverse events (both all and possibly, probably or definitely related to the study intervention) reported per study arm during the course of the study,. 2. Permanent withdrawal from study intervention due to an adverse event that is possibly, probably or definitely related to the study intervention, including reason for withdrawal; 3. Having at least one SAE that is possibly, probably or definitely related to the study intervention, between administration of the first dose of study medication and Day 180.
Time frame: Day 180
To compare between control arm and each investigational arm, the change in patient-reported outcomes over time between treatment arms
Assessment of patient-reported outcomes by: 1. Dermatology Life Quality Index (DLQI) and Children's DLQI (cDLQI): measured at Day 1, Day 42, Day 90, and Day 180 as a discrete number that can be categorized. Change in patient reported outcome will be measured as the difference in score between the subsequent visits (Day 42, Day 90, and Day 180) and Day 1, and compared between arms. 2. Cutaneous Leishmaniasis Impact Questionnaire : measured at Day 1, Day 42, Day 90, and Day 180 as a discrete number. Change in patient reported outcome will be measured as the difference in score between the subsequent visits (Day 90, Day 180) and Day 1, and compared between arms. 3. Patient and Observer Scar Assessment Score measured at Day 42, Day 90, and Day 180 as a discrete number. Scores for each time point will be compared between arms.
Time frame: Day 1, Day 42, Day 90, Day 180
PK/PD outcome: To assess plasma and skin concentrations of SSG, miltefosine, paromomycin, LAmB, and pentamidine
Assessment of drug concentrations: Median (interquartile range) concentrations of sodium stibogluconate, miltefosine, paromomycin, liposomal amphotericin B, and pentamidine will be measured in plasma and skin at EoT, along with the corresponding skin-to-plasma concentration ratios.
Time frame: Day 14, Day 21 or Day 28 depending on treatment arm
PK/PD outcome: To characterize the PK profiles of SSG, miltefosine, paromomycin, LAmB, and pentamidine
Characterization of plasma exposure: Total and partial plasma exposure to sodium stibogluconate, miltefosine, paromomycin, liposomal amphotericin B, and pentamidine will be characterized by calculating the area under the concentration-time curve (AUC) over relevant intervals (e.g., AUC0-24h, AUC0-EOT, AUC0-∞).
Time frame: from 24 hours post dose until Day 14, Day 21 or Day 28 depending treatment arm
PK/PD outcome: To evaluate the correlation between PK parameters and clinical outcome within the control arm and each investigational arm.
Correlation between plasma drug exposure and clinical outcomes. Plasma exposure to will be measured using the area under the plasma concentration-time curve (AUC₀-24h, AUC₀-EOT, AUC₀-∞) derived from pharmacokinetic plasma concentration measurements. Clinical outcomes will be assessed by investigator evaluation of lesion healing and categorized as cure of all lesions, substantial improvement of all lesions, or treatment failure at Day 90 and/or Day 180. Correlation between AUC values and clinical outcome categories will be evaluated within each treatment arm
Time frame: Day 90, Day 180
PK/PD Outcome: To evaluate Leishmania parasite clearance in the control arm and each investigational arm, as assessed by direct microscopy and/or quantitative PCR (qPCR).
Parasite reduction: Percentage reduction in parasite load from baseline will be assessed in skin lesion samples collected during treatment and at EoT, by direct microscopy and/or qPCR. Pairwise comparisons will be made between each investigational arm and the control arm.
Time frame: During treatment and at Day 14, Day 21 or Day 28 depending on treatment arm
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Mar 2029, 26 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Miltefosine · Paromomycin · Liposomal amphotericin B · Pentamidine
Institute of Tropical Medicine, Belgium →