A phase III multicentre, randomised, controlled, clinical trial to assess the safety and efficacy of injectable paromomycin in patients with visceral leishmaniasis (India)
- Conditions
- Visceral leishmaniasis (VL)Infections and Infestations
- Registration Number
- ISRCTN68386084
- Lead Sponsor
- ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 667
1. Aged 5 to 55 years (inclusive) of either gender
2. Confirmed diagnosis by spleen or bone marrow aspirate
3. Clinical signs and symptoms compatible with VL
4. Lab tests:
4.1. Haemoglobin more than 5.0/100 ml
4.2. White Blood Cell (WBC) count more than 1 x 10^9 l
4.3. Platelet count more than 50 x 10^9 l
4.4. Aspartate transaminase (AST), alanine transaminase (ALT) and Alkaline Phosphatase less than three times upper normal limit
4.5. Prothrombin time less than five seconds above control
4.6. Serum creatinine within normal limits
4.7. Serum potassium within normal limits
5. Human Immunodeficiency Virus (HIV) negative
1. History of intercurrent or concurrent diseases that may introduce variable that affect the outcome of the study
2. Any condition which the investigator thinks may prevent the patient from completing the study therapy
3. An abnormal baseline audiogram and/or a history of vestibular or auditory dysfunction
4. Proteinuria (more than 2 g/day)
5. A history of hypersensitivity or allergy to aminoglycosides
6. History of major surgery within last two weeks
7. Pregnancy or lactation
8. Previous treatment for VL within two weeks of enrolment into the study
9. Prior treatment failures with paromomycin or amphotericin B
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety:<br>1. Reported adverse events<br>2. Protocol-defined nephrotoxicity and ototoxicity<br>3. Laboratory evaluations<br>4. Vital signs
- Secondary Outcome Measures
Name Time Method Efficacy:<br>1. Parasite density <br>2. Final cure <br>3. Relapse<br>4. Treatment failure