Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2015 Oct 23;9(10):e0004118.
doi: 10.1371/journal.pntd.0004118. eCollection 2015.

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

Kazi M Jamil  1 , Rashidul Haque  2 , Ridwanur Rahman  3 , M Abul Faiz  4 , Abu Toha Md Rezwanul Haque Bhuiyan  2 , Amresh Kumar  5 , Syed Misbah Hassan  5 , Heather Kelly  5 , Pritu Dhalaria  6 , Sonali Kochhar  7 , Philippe Desjeux  5 , Mohammad A A Bhuiyan  2 , Mohammed M Khan  2 , Raj Shankar Ghosh  8
Affiliations
Clinical Trial

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

Kazi M Jamil et al. PLoS Negl Trop Dis. .

Abstract

Background: This study was conducted in Bangladeshi patients in an outpatient setting to support registration of Paromomycin Intramuscular Injection (PMIM) as a low-cost treatment option in Bangladesh.

Methodology: This Phase IIIb, open-label, multi-center, single-arm trial assessed the efficacy and safety of PMIM administered at 11 mg/kg (paromomycin base) intramuscularly once daily for 21 consecutive days to children and adults with VL in a rural outpatient setting in Bangladesh. Patients ≥5 and ≤55 years were eligible if they had signs and symptoms of VL (intermittent fever, weight loss/decreased appetite, and enlarged spleen), positive rK39 test, and were living in VL-endemic areas. Compliance was the percentage of enrolled patients who received 21 daily injections over no more than 22 days. Efficacy was evaluated by initial clinical response, defined as resolution of fever and reduction of splenomegaly at end of treatment, and final clinical response, defined as the absence of new clinical signs and symptoms of VL 6 months after end of treatment. Safety was assessed by evaluation of adverse events.

Principal findings: A total of 120 subjects (49% pediatric) were enrolled. Treatment compliance was 98.3%. Initial clinical response in the Intent-to-Treat population was 98.3%, and final clinical response 6 months after end of treatment was 94.2%. Of the 119 subjects who received ≥1 dose of PMIM, 28.6% reported at least one adverse event. Injection site pain was the most commonly reported adverse event. Reversible renal impairment and/or hearing loss were reported in 2 subjects.

Conclusions/significance: PMIM was an effective and safe treatment for VL in Bangladesh. The short treatment duration and lower cost of PMIM compared with other treatment options may make this drug a preferred treatment to be investigated as part of a combination therapy regimen. This study supports the registration of PMIM for use in government health facilities in Bangladesh.

Trial registration: ClinicalTrials.gov identifier: NCT01328457.

PubMed Disclaimer

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Patient disposition flow chart.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Joshi A, Narain JP, Prasittisuk C, Bhatia R, Hashim G, et al. (2008) Can visceral leishmaniasis be eliminated from Asia? J Vector Borne Dis 45: 105–111. - PubMed
    1. Rahman KM, Islam N (1983) Resurgence of visceral leishmaniasis in Bangladesh. Bull World Health Organ 61: 113–116. - PMC - PubMed
    1. World Health Organization. (2011) Bangladesh. http://www.who.int/leishmaniasis/resources/BANGLADESH.pdf.
    1. Sundar S, Jha TK, Thakur CP, et al. (2007) Injectable paromomycin for visceral leishmaniasis in India. N Engl J Med 356: 2571–2581. - PubMed
    1. Sinha PK, Jha TK, Thakur CP, et al. (2011) Phase 4 pharmacovigilance trial of paromomycin injection for the treatment of visceral leishmaniasis in India. J Trop Med 2011: 645203 10.1155/2011/645203 - DOI - PMC - PubMed

Publication types

MeSH terms

Associated data

Grants and funding

This work was funded by the Bill and Melinda Gates Foundation. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

LinkOut - more resources