Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis

PATH

Status and phase: Completed; Phase 4

Conditions: Visceral Leishmaniasis

Treatments: Drug: Paromomycin sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT00604955

VLPM03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 patients

Sex: All

Ages: 2 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed, newly diagnosed or relapsed visceral leishmaniasis

Exclusion criteria

• HIV infection, tuberculosis
• Significant hematologic, renal or liver dysfunction
• Malaria
• Those unable to be treated as an outpatient.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

2,000 participants in 1 patient group

A

Experimental group

Description:

Paromomycin IM Injection (approved product in India)

Treatment:

Drug: Paromomycin sulfate