Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar
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Purpose
Miltefosine and liposomal amphotericin B (AmBisome) are approved drugs for visceral leishmaniasis. In this study both drugs will be given in a sequential manner. AmBisome will be given on day 1, followed by Miltefosine for 14 days. Final Cure will be evaluated at six months.
| Condition | Intervention | Phase |
|---|---|---|
|
Visceral Leishmaniasis |
Drug: Liposomal amphotericin B and Miltefosine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Efficacy and Safety of a Short Course of Miltefosine and Liposomal Amphotericin B for Visceral Leishmaniasis in India |
- Final Cure six months after the end of treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 150 |
| Study Start Date: | October 2007 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg. Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15) |
Drug: Liposomal amphotericin B and Miltefosine
Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg. Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15) Other Name: AmBisome and Impavido
|
Detailed Description:
Methodology Multicenter trial, eligible patients will be treated with Liposomal amphotericin B (5 mg/kg) on day 1 and then with miltefosine capsules for 14 days (days 2-15).
At two weeks after the end of treatment the initial cure (clinical and parasitological cure) and the clinical response will be determined. If initial cure is observed, a patient will be evaluated after a 6 months (after end of treatment) follow up period for final clinical cure.
Number of patients planned Total number of patients planned: 150 patients at both centers combined. 75 pediatric (2-11 years); 75 adult (12-65 years).
Lack of suitability for the trial:
- Post Kala-azar Dermal Leishmaniasis (PKDL)
- Concomitant treatment with other anti-leishmanial drugs
- Any condition which compromises ability to comply with the study procedures
Administrative reasons:
- Any condition or situation that compromises compliance with study procedures including follow-up visit Study medication, dose and mode of administration Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg.
Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15)
Dosage:
- weighing ≥ 25 kg: 100 mg miltefosine daily as one capsule (50 mg) in the morning and one capsule in the evening, after meals for 14 days.
weighing < 25 kg: 50 mg miltefosine daily as one capsule (50 mg) in the morning, after meals for 14 days. Parameter for evaluation
- Final cure rate (initial parasite cure and clinical assessment at six month EOT)
- Initial parasitological cure rate (based on splenic aspirates or Bone marrow aspirate)
- Clinical response at end of treatment (clinical assessment)
- Adverse events
Statistical methods
- Calculation of cure rate with 95% and 90% lower confidence limit according to Clopper Pearson
- Calculation of overall incidence of adverse events
Eligibility| Ages Eligible for Study: | 2 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female age between 2 and 65 years (inclusive)
- Parasites visualized on splenic aspiration
- Signs and symptoms compatible with visceral leishmaniasis (e.g. fever, splenomegaly, anaemia, weight loss, leucopenia, thrombocytopenia)
- Confirmed diagnosis of VL by visualization of parasites on splenic/bone marrow aspirate
- Fever for at least 2 weeks
- Written informed consent from the patient/or from parent or guardian if under 18 years old
Exclusion Criteria:
- Hemoglobin < 6 g/dl
- White blood cell count < 1000/mm3
- Platelets <50,000
- Prothrombin time > 5 sec above control
- ASAT > 3 times the upper limit of normal
- Serum creatinine or BUN > 1.5 times the upper limit of normal
- Malaria
- Tuberculosis
- HIV positive serology
- Lactation, pregnancy
- Refusing contraception method during treatment period plus 3 months
- Any medical condition(s) that upon judgment of physician may affect the safety of the patient when treated with study drugs
- Any concomitant drug that is nephrotoxic
Contacts and Locations| India | |
| Kala-azar Medical Research Center | |
| Muzaffarpur, Bihar, India, 842001 | |
| Rajendra Memorial Research Institute of Medical Sciences | |
| Patna, Bihar, India | |
| Principal Investigator: | Shyam Sundar, MD | Banaras Hindu University |
| Principal Investigator: | Prabhat K Sinha, MD | Rajendra Memorial Research Institute of Medical Sciences |
More Information
Publications:
| Responsible Party: | Shyam Sundar, Professor, Banaras Hdindu University |
| ClinicalTrials.gov Identifier: | NCT00371995 History of Changes |
| Other Study ID Numbers: | LEI PDE 06 03 |
| Study First Received: | September 5, 2006 |
| Last Updated: | June 21, 2011 |
| Health Authority: | India: Ministry of Health |
Keywords provided by Banaras Hindu University:
|
Visceral leishmaniasis kala-azar miltefosine AmBisome |
Additional relevant MeSH terms:
|
Leishmaniasis Leishmaniasis, Visceral Euglenozoa Infections Protozoan Infections Parasitic Diseases Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases Amphotericin B Liposomal amphotericin B |
Miltefosine Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Bacterial Agents Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 22, 2013