Document Detail

Short-course paromomycin treatment of visceral leishmaniasis in India: 14-day vs 21-day treatment.
MedLine Citation:
PMID:  19663597     Owner:  NLM     Status:  MEDLINE    
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. ( identifier: NCT00629031).
Shyam Sundar; Neha Agrawal; Rakesh Arora; Dipti Agarwal; Madhukar Rai; Jaya Chakravarty
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Clinical infectious diseases : an official publication of the Infectious Diseases Society of America     Volume:  49     ISSN:  1537-6591     ISO Abbreviation:  Clin. Infect. Dis.     Publication Date:  2009 Sep 
Date Detail:
Created Date:  2009-08-21     Completed Date:  2009-11-05     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9203213     Medline TA:  Clin Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  914-8     Citation Subset:  IM    
Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.
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MeSH Terms
Antiprotozoal Agents / administration & dosage,  adverse effects,  therapeutic use*
Child, Preschool
Dose-Response Relationship, Drug
Drug Administration Schedule
Injections, Intramuscular / adverse effects
Leishmaniasis, Visceral / drug therapy*
Middle Aged
Paromomycin / administration & dosage,  adverse effects,  therapeutic use*
Time Factors
Treatment Outcome
Young Adult
Reg. No./Substance:
0/Antiprotozoal Agents; 7542-37-2/Paromomycin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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