| Short-course paromomycin treatment of visceral leishmaniasis in India: 14-day vs 21-day treatment. | |
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MedLine Citation:
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PMID: 19663597 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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.gov identifier: NCT00629031). |
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Authors:
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Shyam Sundar; Neha Agrawal; Rakesh Arora; Dipti Agarwal; Madhukar Rai; Jaya Chakravarty |
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Publication Detail:
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Type: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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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:
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Created Date: 2009-08-21 Completed Date: 2009-11-05 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9203213 Medline TA: Clin Infect Dis Country: United States |
Other Details:
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Languages: eng Pagination: 914-8 Citation Subset: IM |
Affiliation:
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Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India. drshyamsundar@hotmail.com |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00629031 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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 |
| Chemical | |
Reg. No./Substance:
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0/Antiprotozoal Agents; 7542-37-2/Paromomycin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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