Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to determine the use of delivering point of care, rapid diagnosis with rK39 and treatment with AmBisome single dose of 10 mg/kg when administrated in the Primary Health Center (PHC) settings with regard to operational feasibility, safety and final cure rate at 6 months after end of treatment. Point of care diagnosis and treatment (PCDT) at the PHC level would bring the best available interventions closer to the patients with visceral leishmaniasis (VL) whose villages are within several kilometers of the PHC. This would support the VL elimination program in the Indian subcontinent.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Banaras Hindu University
• Collaborator: Rajendra Memorial Research Institute of Medical Sciences
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

Inclusion Criteria:

1. Male or female patients ≥ 5 years of age

2. History of fever for more than 2 weeks

3. Splenomegaly

4. rK 39 rapid test positive

5. Biochemical and hematological test values as follows:

• Hemoglobin ≥ 5 g/dl

• White blood cell count ≥1.0 x 109/L

• AST, ALT ≤ 3 times the upper limit of normal

• Serum creatinine level within normal limit

6. Written informed consent from the patient/ or parent or guardian if under 18 years old.

Exclusion Criteria:

1. A history of intercurrent or presence of clinical signs / symptoms of concurrent diseases / conditions (e.g. Chronic alcohol consumption or drug addiction, renal, hepatic, cardiovascular or CNS disease; diabetes mellitus, dehydration, other infectious diseases or major psychiatric diseases) only if the intercurrent conditions are not under control before starting the treatment with AmBisome.

2. Any condition which according to the investigator might prevent the patient from completing the study therapy and subsequent follow up

3. A history of allergy or hypersensitivity to Amphotericin B

4. Previous treatment for VL

5. Prior treatment failure with Amphotericin B

6. Post Kala-azar Dermal Leishmaniasis (PKDL