Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar
- Conditions
- Visceral Leishmaniasis
- Interventions
- Drug: Liposomal amphotericin B and Miltefosine
- Registration Number
- NCT00371995
- Lead Sponsor
- Banaras Hindu University
- Brief Summary
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.
- 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:
1. 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.
2. 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 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)
- Primary Outcome Measures
Name Time Method Final Cure six months after the end of treatment 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Rajendra Memorial Research Institute of Medical Sciences
🇮🇳Patna, Bihar, India
Kala-azar Medical Research Center
🇮🇳Muzaffarpur, Bihar, India