Visceral Leishmaniasis Clinical Trial
Official title:
A Phase 3 Multicenter, Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Injectable Paromomycin in Patients With Visceral Leishmaniasis
Verified date | October 2014 |
Source | PATH |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Ministry of Health |
Study type | Interventional |
Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.
Status | Completed |
Enrollment | 667 |
Est. completion date | November 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Age between 5-55 years (inclusive) of either gender. - Newly diagnosed VL or VL treatment failure confirmed by spleen or bone marrow aspirate. - Clinical signs and symptoms compatible with VL: fever of over two weeks duration and splenomegaly. - Biochemical and haematological test values as follows: - Haemoglobin > 5.0g/100mL - White blood cell count > 1 x109/L - Platelet count > 50 x 109/L - AST, ALT and alkaline phosphatase < 3 times upper normal limit - Prothrombin time < 5 seconds above control - Serum creatinine levels within normal limits - Serum potassium levels within normal limits - HIV negative Exclusion Criteria: - A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or central nervous system disease; diabetes; tuberculosis or other infectious or major psychiatric diseases) that may introduce variables affecting the outcome of the study. - Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up. - An abnormal baseline audiogram (presentation with 75 dB or higher at 8KHz or below) and/or a history of significant vestibular or auditory dysfunction. - Proteinuria (> 2+). - A history of allergy or hypersensitivity to aminoglycosides. - A history of major surgery within the last two weeks. - Pregnancy or lactation. [Note: women of childbearing age must use an adequate form of contraception (documented) or agree to a period of sexual abstinence during the treatment phase of the study.] - Previous treatment for VL within two weeks of enrolment into the study. - Prior treatment failures with paromomycin or amphotericin B. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Rajendra Memorial Research Institute of Medical Sciences (ICMR) | Agam Kuan, Patna | Bihar |
India | Kalazar Research Centre | Brahmpura, Muzaffarpur | Bihar |
India | Kalazar Research Centre | Patna | Bihar |
India | Kala-azar Medical Research Centre | Rambagh Road Muzaffarpur | Bihar |
Lead Sponsor | Collaborator |
---|---|
PATH | World Health Organization |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | (1) To compare the safety of injectable paromomycin to amphotericin B when administered in the proposed dosage regimens. | |||
Primary | (2) To compare the efficacy of injectable paromomycin to amphotericin B with regards to final cure rates. | |||
Secondary | - Characterization of the pharmacokinetics of injectable paromomycin in adults and children with VL | |||
Secondary | - Comparison of initial cure rates for the two regimens | |||
Secondary | - Comparison of clinical improvement rates for the two regimens |
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