ISRCTN68386084
Completed
Not Applicable
A phase III multicentre, randomised, controlled, clinical trial to assess the safety and efficacy of injectable paromomycin in patients with visceral leishmaniasis (India)
ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)0 sites667 target enrollmentJune 7, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Visceral leishmaniasis (VL)
- Sponsor
- ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
- Enrollment
- 667
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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