drugset / Trial / NCT01328457
An Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh
Completed
120 enrolled
PATH
GVK Biosciences · collabInternational Centre for Diarrhoeal Disease Research, Bangladesh · collabShaheed Suhrawardy Medical College and Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the effectiveness of treatment with PMIM in patients with visceral leishmaniasis within the VL-endemic region of Bangladesh at EOT (21/22 days after treatment begins), and at 6 months after end of treatment (Day 202/203, -15 to +30 days).
Timeline
- Start
- 2011-01
- Primary completion
- 2011-05
- Completion
- 2012-06
Publications
- Background Sundar S, Jha TK, Thakur CP, Sinha PK, Bhattacharya SK. Injectable paromomycin for Visceral leishmaniasis in India. N Engl J Med. 2007 Jun 21;356(25):2571-81. doi: 10.1056/NEJMoa066536.
- Background Kanyok TP, Killian AD, Rodvold KA, Danziger LH. Pharmacokinetics of intramuscularly administered aminosidine in healthy subjects. Antimicrob Agents Chemother. 1997 May;41(5):982-6. doi: 10.1128/AAC.41.5.982.
- Jamil KM, Haque R, Rahman R, Faiz MA, Bhuiyan AT, Kumar A, Hassan SM, Kelly H, Dhalaria P, Kochhar S, Desjeux P, Bhuiyan MA, Khan MM, Ghosh RS. Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh. PLoS Negl Trop Dis. 2015 Oct 23;9(10):e0004118. doi: 10.1371/journal.pntd.0004118. eCollection 2015.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paromomycin | Small molecule | 11 mg/kg | Intramuscular |