Short-course paromomycin treatment of visceral leishmaniasis in India: 14-day vs 21-day treatment.

Abstract

BACKGROUND:

Treatment of visceral leishmaniasis (VL) is far from satisfactory. There is an urgent need for a therapy that is efficacious, safe, affordable, and of short duration.

METHODS:

A randomized open-label study was conducted to assess the efficacy and safety of 2 regimens of paromomycin administered intramuscularly. Group A received 11 mg/kg/day for 14 days (n = 217) and group B received 11 mg/kg/day for 21 days (n = 112) for the treatment of VL in India.

RESULTS:

Mild grade injection site pain was the most common adverse event. There was no nephrotoxicity, but 4 patients in group A had to discontinue treatment because of grade 3 elevation of hepatic enzymes. Initial cure was observed in 91.2% and 96.4% of patients in group A and group B, respectively. Definitive cure at 6 months of follow up was seen in 82% of patients in group A and 92% of patients in group B by intention-to-treat analysis and in 84.3% of patients in group A and 92.8% of patients in group B by per protocol analysis.

CONCLUSIONS:

Although the cure rate in the group of patients who received the 14-day regimen was not optimal, the results with respect to initial cure were encouraging. Further studies that combine a short course of paromomycin with treatment with another antileishmanial agent are warranted. ( ClinicalTrials.gov identifier: NCT00629031).

• Authors: Shyam Sundar, Neha Agrawal, Rakesh Arora, Dipti Agarwal, Madhukar Rai, Jaya Chakravarty
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 49 Issue 6 Pg. 914-8 (Sep 15 2009) ISSN: 1537-6591 [Electronic] United States
• PMID: 19663597 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiprotozoal Agents
• Paromomycin

Topics

• Adolescent
• Adult
• Animals
• Antiprotozoal Agents (administration & dosage, adverse effects, therapeutic use)
• Child
• Child, Preschool
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Humans
• India
• Injections, Intramuscular (adverse effects)
• Leishmaniasis, Visceral (drug therapy)
• Male
• Middle Aged
• Paromomycin (administration & dosage, adverse effects, therapeutic use)
• Time Factors
• Treatment Outcome
• Young Adult