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Sponsors and Collaborators: |
Institute for OneWorld Health World Health Organization |
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Information provided by: | Institute for OneWorld Health |
ClinicalTrials.gov Identifier: | NCT00216346 |
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 |
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Visceral Leishmaniasis |
Drug: Paromomycin sulfate Drug: Amphotericin B |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
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:
India, Bihar | |
Kalazar Research Centre | |
Brahmpura, Muzaffarpur, Bihar, India, 842003 | |
Kala-azar Medical Research Centre | |
Rambagh Road Muzaffarpur, Bihar, India, 842001 | |
Kalazar Research Centre | |
Balaji Utthan Sanastan, Fraser Road "Uma Complex" Patna, Bihar, India, 800001 | |
Rajendra Memorial Research Institute of Medical Sciences (ICMR) | |
AGAM KUAN, Patna, Bihar, India, 800 007 |
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) |
Study ID Numbers: | VLPM01 |
Study First Received: | September 13, 2005 |
Last Updated: | December 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00216346 |
Health Authority: | India: Ministry of Health |
Leishmaniasis Abelcet Protozoan Infections Amphotericin B Skin Diseases Clotrimazole Miconazole |
Tioconazole Liposomal amphotericin B Paromomycin Skin Diseases, Infectious Leishmaniasis, Visceral Parasitic Diseases |
Anti-Bacterial Agents Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Skin Diseases, Parasitic Antifungal Agents |
Therapeutic Uses Antibiotics, Antifungal Sarcomastigophora Infections Mastigophora Infections Amebicides Pharmacologic Actions |