Status:
COMPLETED
An Open Lable Randomised Study to Assess the Safety and Efficacy of Short Course Paromomycin in Visceral Leishmaniasis
Lead Sponsor:
Banaras Hindu University
Conditions:
Visceral Leishmaniasis
Eligibility:
All Genders
5-55 years
Phase:
PHASE3
Brief Summary
It is a randomized, double-blind, multi-center, two-arm study intended to assess the safety and efficacy of three different doses/dose regimens of paromomycin administered intramuscularly as follows: ...
Detailed Description
Paromomycin administered at a dose of 11 mg/kg/day IM for 21 days was previously demonstrated by iOWH and WHO to be as effective as amphotericin B administered IV at a dose of 1 mg/kg/every other day ...
Eligibility Criteria
Inclusion
- Children and adults, male or female, aged 5 to 55 years, inclusive, who have provided written informed consent.
- New or relapsed VL or prior VL treatment failure on a regimen not containing Paromomycin or AmBisome®. The diagnosis of VL must be confirmed by a parasite-positive splenic aspirate.
Exclusion
- LFT greater than 3 times ULN ( AST, ALT, S.Bilirubin, Alkaline Phosphatase, Hb \< 4 gm/dl.
- Platelet \<40,000/ mm3
- Prothrombin Time \> 3 Sec. longer than Control.
- Creatinine \> 3 times
- Normal Value For Male ( 0.6 to 1.1)
- Normal Value For Female ( 0.5 to 0.9)
- Absolute Leucocyte count- \< 1,000
- HIV infection
- Abnormal audiometric and/or vestibular dysfunction
- History of renal dysfunction
- Other severe medical conditions
- History of allergy or hypersensitivity to aminoglycosides
- Treatment with a parenteral aminoglycoside within 28 days prior to randomisation
- Previous VL treatment within the past 14 days
- Previous treatment for VL with paromomycin at any time
- Pregnancy, lactation, or lack of use of contraception in women of childbearing potential
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
329 Patients enrolled
Trial Details
Trial ID
NCT00629031
Start Date
February 1 2008
End Date
August 1 2008
Last Update
September 12 2008
Active Locations (1)
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1
Kala-azar Medical Research Center, Rambag Road
Varanasi, India, 842001