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| Name | Class |
|---|---|
| Drugs for Neglected Diseases | OTHER |
| Rajendra Memorial Research Institute of Medical Sciences | OTHER |
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Rationale
The overall objective of this trial is to identify a safe and effective combination, (co-administration) short course treatment for the treatment of VL which could be easily deployed in a control programme. The hypothesis is that the combination treatment is as effective or better than the 5 mg/kg single dose of AmBisome and will reduce the risk of parasite resistance occurring. Safety and tolerability should be such that the combination can be easily deployed.
Objective
The specific primary and secondary objectives are as follows:
Primary objective:
To identify a short course combination treatment regimen which is at least as effective as a single dose of AmBisome 5mg/kg
Secondary objective:
To compare safety and tolerability of the various treatments measured by vital signs, blood biochemistry, (renal and liver function tests) haematology, spontaneous and elicited adverse event reporting
Primary Endpoint:
The primary efficacy endpoint variable is parasitological clearance 2 weeks after start of treatment with no relapse during follow up and no clinical signs or symptoms of VL at 6 months post treatment.
Parasitology is only carried out at any time during follow-up or at six months post treatment if there are signs or symptoms of VL infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | AmBisome 5 mg/kg iv infusion over 2 h x 1 day (single dose) + oral miltefosine 50mg once daily (< 25 kg body weight) or twice daily ( > 25 kg body weight) or 2.5 mg/kg for children under 12 years, for 7 days on day 2-8 |
|
| B | Experimental | AmBisome 5mg/kg iv infusion over 2 h x 1 day (single dose) + paromomycin sulfate 15 mg/kg/day i.m for 10 days, on day 2-11 |
|
| C | Experimental | oral miltefosine 50mg once daily (< 25 kg body weight) or twice daily ( > 25 kg body weight) or 2.5 mg/kg for children under 12 years, for 10 days + Paromomycin sulfate 15 mg/kg/day im. for 10 days |
|
| D | Active Comparator | amphotericin B deoxycholate at 1 mg/kg every other day for 15 infusions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amphotericin B deoxycholate | Drug | Amphotericin B deoxycholate 1 mg/kg on alternate days for 15 infusions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Final cure at six month follow up | 18 months | |
| Cure at six month follow up | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Initial cure at the end of treatment | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shyam Sundar, MD | Institute of Medical Sciences, Banaras HIndu University | Principal Investigator |
| P K Sinha, MD | Rajendra Memorial Research Insititute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kala-azar Medical Research Center | Muzaffarpur | Bihar | 842001 | India |
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| ID | Term |
|---|---|
| D007898 | Leishmaniasis, Visceral |
| ID | Term |
|---|---|
| D007896 | Leishmaniasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| C059765 | amphotericin B, deoxycholate drug combination |
| C068538 | liposomal amphotericin B |
| C039128 | miltefosine |
| D010303 | Paromomycin |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Liposomal Amphotericin B with Miltefosine | Drug | Liposomal Amphotericin B 5 mg Miltefosine 50 mg twice daily if patient weighs equal to or > 25 kg Miltefosine 50 mg once daily if patient weighs <25 mg |
|
| Liposomal Amphotericin B and Paromomycin Sulfate | Drug | AmBisome 5mg/kg iv infusion over 2 h x 1 day (single dose) + paromomycin sulfate 15 mg/kg/day i.m for 10 days, on day 2-11 |
|
| miltefosine + Paromomycin sulfate | Drug | oral miltefosine 50mg once daily (< 25 kg body weight) or twice daily ( > 25 kg body weight) or 2.5 mg/kg for children under 12 years, for 10 days + Paromomycin sulfate 15 mg/kg/day im. for 10 days |
|
| D007239 |
| Infections |
| D000079426 | Vector Borne Diseases |