Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis
- Registration Number
- NCT00604955
- Lead Sponsor
- PATH
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2000
- Confirmed, newly diagnosed or relapsed visceral leishmaniasis
- HIV infection, tuberculosis
- Significant hematologic, renal or liver dysfunction
- Malaria
- Those unable to be treated as an outpatient.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Paromomycin sulfate Paromomycin IM Injection (approved product in India)
- Primary Outcome Measures
Name Time Method M2&3: Program effectiveness as measured by specific criteria for healthcare workers, patients, and operational systems. approximately 2.5 years M1: Safety as measured by adverse events, serious adverse events, vital signs, and laboratory parameters. M1: Approximately 6 months
- Secondary Outcome Measures
Name Time Method M1: Clinical cure as measured by temperature/hx of fever, spleen size decrease by at least 33% from baseline, and clinical assessment of treating physician. M1: Approximately 6 months M2 and M3: Clinical cure as measured by temperature/hx of fever, spleen size decrease, and clinical assessment of treating physician. approximately 6 months
Trial Locations
- Locations (7)
Rajendra Memorial Research Institute of Medical Sciences
🇮🇳Agam Kuan, Patna, Bihar, India
Shrimati Hazari Maternity and Medical Care
🇮🇳Azad Nagar, Balua Tal, Motihari, Bihar, India
Research Centre for Diabetes, Hypertension and Obesity
🇮🇳Bengali Tola, Samastipur, Bihar, India
Kala-zar Research Centre
🇮🇳Patna, Bihar, India
Dr. A.K. Aditya Clinic
🇮🇳East of Bhola Talkies, Samastipur, Bihar, India
Kalazar Research Centre
🇮🇳Brahmpura, Muzaffarpur, Bihar, India
Kala-azar Medical Research Centre
🇮🇳Rambagh Road, Muzaffarpur, Bihar, India