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| Sponsor: | Institute for OneWorld Health |
|---|---|
| Collaborator: |
World Health Organization |
| Information provided by: | Institute for OneWorld Health |
| ClinicalTrials.gov Identifier: | NCT00216346 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Visceral Leishmaniasis |
Drug: Paromomycin sulfate Drug: Amphotericin B |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3 Multicenter, Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Injectable Paromomycin in Patients With Visceral Leishmaniasis |
| Estimated Enrollment: | 667 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | November 2004 |
Eligibility| Ages Eligible for Study: | 5 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Biochemical and haematological test values as follows:
Exclusion Criteria:
Contacts and Locations| India | |
| Rajendra Memorial Research Institute of Medical Sciences (ICMR) | |
| AGAM KUAN, Patna, Bihar, India, 800 007 | |
| Kalazar Research Centre | |
| Balaji Utthan Sanastan, Fraser Road "Uma Complex" Patna, Bihar, India, 800001 | |
| Kalazar Research Centre | |
| Brahmpura, Muzaffarpur, Bihar, India, 842003 | |
| Kala-azar Medical Research Centre | |
| Rambagh Road Muzaffarpur, Bihar, India, 842001 | |
| Principal Investigator: | Prof S. Sundar | Kala-azar Research Centre |
| Principal Investigator: | Prof T.K. Jha | Kalazar Research Centre |
| Principal Investigator: | Prof C.P. Thakur | Kalazar Research Centre |
| Principal Investigator: | Dr. S.K. Bhattacharya | Rajendra Memorial Research Institute of Medical Sciences (ICMR) |
More Information
| ClinicalTrials.gov Identifier: | NCT00216346 History of Changes |
| Other Study ID Numbers: | VLPM01 |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 13, 2005 |
| Health Authority: | India: Ministry of Health |
|
Leishmaniasis Leishmaniasis, Visceral Euglenozoa Infections Protozoan Infections Parasitic Diseases Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases Amphotericin B Paromomycin |
Liposomal amphotericin B Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Bacterial Agents |