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Sponsored by: |
Institute for OneWorld Health |
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Information provided by: | Institute for OneWorld Health |
ClinicalTrials.gov Identifier: | NCT00604955 |
This modular Program will first confirm the safety and efficacy of Paromomycin IM Injection when given to an expanded population in the outpatient setting in experienced VL centers and subsequently evaluate the effectiveness of an expanded access model of providing Paromomycin IM Injection to progressively more resource-constrained clinics in Bihar, India.
Condition | Intervention | Phase |
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Visceral Leishmaniasis |
Drug: Paromomycin sulfate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 4 Study to Expand Access Program While Assessing the Safety and Efficacy of Paromomycin IM Injection in an Outpatient Setting for the Treatment of Visceral Leishmaniasis |
Estimated Enrollment: | 2000 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | June 2010 |
Arms | Assigned Interventions |
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A: Experimental
Paromomycin IM Injection (approved product in India)
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Drug: Paromomycin sulfate
Paromomycin will be administered intramuscularly at 11 mg/kg, once a day, for 21 consecutive days
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Safe, effective, and affordable treatments for visceral leishmaniasis (VL) that are widely available to the poorest population of rural India where the disease is endemic are urgently needed. Resistance to antimonials, which have historically been the first line of treatment for VL in Bihar and adjoining states, is a major problem. Other available treatments are limited by their high cost, toxicity, or contraindications in certain populations. Paromomycin IM Injection was approved for the treatment of VL in August 2006 by the Drug Controller General of India (DCGI).
The study is designed to establish a Phase 4 Access Program in a modular, stepwise fashion (Modules 1 to 3). The study will first confirm the safety and efficacy of Paromomycin IM Injection in an expanded VL population treated as an outpatient in experienced centers (Module 1); and then progressively extend the network of treatment facilities, the number and reach of the trained staff, and the implementation of the requisite logistics systems to rural Bihar (Modules 2 and 3). An expanded network of healthcare workers will be trained and supervised to make a preliminary diagnosis of VL; to make appropriate referrals to confirm the diagnosis of VL; to treat with Paromomycin IM Injection; and to assess patient safety and clinical response on an outpatient basis.
Ages Eligible for Study: | 2 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Syed M Hassan, MD | 91-612-2274371 ext 3 | shassan@oneworldhealth.org |
India, Bihar | |
Rajendra Memorial Research Institute of Medical Sciences | Recruiting |
Agam Kuan, Patna, Bihar, India, 800 007 | |
Principal Investigator: P K Sinha, MD | |
Kala-azar Medical Research Centre | Recruiting |
Rambagh Road, Muzaffarpur, Bihar, India, 842 001 | |
Principal Investigator: Shyam Sundar, MD | |
Kala-zar Research Centre | Recruiting |
Balaji Utthan Sanastan, Fraser Road "Uma Complex", Patna, Bihar, India, 800 001 | |
Principal Investigator: C P Thakur, MD | |
Shrimati Hazari Maternity and Medical Care | Recruiting |
Azad Nagar, Balua Tal, Motihari, Bihar, India, 845 401 | |
Principal Investigator: Devendra Nath, MD | |
Research Centre for Diabetes, Hypertension and Obesity | Recruiting |
Bengali Tola, Samastipur, Bihar, India, 848 101 | |
Principal Investigator: Supriyo Mukherjee, MD | |
Dr. A.K. Aditya Clinic | Recruiting |
East of Bhola Talkies, Samastipur, Bihar, India, 848 101 | |
Principal Investigator: Amrendra K Aditya, MD | |
India, Muzaffarpur, Bihar | |
Kalazar Research Centre | Recruiting |
Brahmpura, Muzaffarpur, Bihar, India, 842 003 | |
Principal Investigator: T K Jha, MD |
Principal Investigator: | P K Sinha, MD | Rajendra Memorial Research Institute of Medical Sciences |
Principal Investigator: | T K Jha, MD | Kalazar Research Centre |
Principal Investigator: | C P Thakur, MD | Kala-azar Research Centre |
Principal Investigator: | Shyam Sundar, MD | Kala-azar Medical Research Centre |
Principal Investigator: | Devendra Nath, MD | Shrimati Hazari Maternity and Medical Care |
Principal Investigator: | Supriyo Mukherjee, MD | Research Centre for Diabetes, Hypertension and Obesity |
Principal Investigator: | Amrendra K Aditya, MD | Dr. A.K. Aditya Clinic |
Study ID Numbers: | VLPM03 |
Study First Received: | January 17, 2008 |
Last Updated: | January 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00604955 |
Health Authority: | India: Ministry of Health |
visceral leishmaniasis kala-azar Bihar, India |
Leishmaniasis Protozoan Infections Skin Diseases, Infectious Skin Diseases |
Parasitic Diseases Leishmaniasis, Visceral Paromomycin |
Anti-Bacterial Agents Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Skin Diseases, Parasitic |
Therapeutic Uses Sarcomastigophora Infections Mastigophora Infections Amebicides Pharmacologic Actions |