NCT01328457

An Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 5 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness of treatment with PMIM in patients with visceral leishmaniasis within the VL-endemic region of Bangladesh at EOT (21/22 days after treatment begins), and at 6 months after end of treatment (Day 202/203, -15 to +30 days).

Detailed description

Safe, effective and affordable treatments for visceral leishmaniasis (VL) that are widely available to the poorest populations are urgently needed in Bangladesh in areas where the disease is endemic. Paromomycin IM Injection (PMIM) was approved for the treatment of VL in August 2006 by the Drugs Controller General of India (DCGI), and it offers an attractive alternative to treatments that are currently available.

Conditions

• Visceral Leishmaniasis

Interventions

Type	Name	Description
DRUG	Paromomycin sulfate	Paromomycin IM Injection, 11 mg/kg as the base, intramuscular, once a day on 21 consecutive days (or no more than 22 days if one injection is missed during the treatment period).

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-05-01
• Completion: 2012-06-01
• First posted: 2011-04-04
• Last updated: 2014-04-04

Locations

3 sites across 1 country: Bangladesh