A phase III multicentre, randomised, controlled, clinical trial to assess the safety and efficacy of injectable paromomycin in patients with visceral leishmaniasis (India)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68386084

Enrollment

667

Registered

2005-06-07

Start date

2003-05-23

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visceral leishmaniasis (VL) Infections and Infestations Visceral leishmaniasis (VL)

Interventions

Intervention group (500 patients): Injectable paromomycin sulphate 15 mg/kg intramuscular per day x 30 days. Control group (167 patients): Injectable amphotericin B 1 mg/kg continuous intravenous i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Safety: 1. Reported adverse events 2. Protocol-defined nephrotoxicity and ototoxicity 3. Laboratory evaluations 4. Vital signs	—

Secondary

Measure	Time frame
Efficacy: 1. Parasite density 2. Final cure 3. Relapse 4. Treatment failure	—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026