Journal Article

Short-Course Paromomycin Treatment of Visceral Leishmaniasis in India: 14-Day vs 21-Day Treatment

Shyam Sundar, Neha Agrawal, Rakesh Arora, Dipti Agarwal, Madhukar Rai and Jaya Chakravarty

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 49, issue 6, pages 914-918
Published in print September 2009 | ISSN: 1058-4838
Published online September 2009 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/605438
Short-Course Paromomycin Treatment of Visceral Leishmaniasis in India: 14-Day vs 21-Day Treatment

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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.govidentifier: NCT00629031).

Journal Article.  2611 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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