Clinical Trial: An Open Lable Randomised Study to Assess the Safety and Efficacy of Short Course Paromomycin in Visceral Leishmaniasis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open Lable Randomised Two -Arm Study to Assess the Safety and Efficacy of Paromomycin Administered Intramuscularly at Two Different Dosing Regimens (14 Days Versus 21 Days) for the Treatment of Ind
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: 11 mg/kg/day for 14 days and 11 mg/kg/day for 21 days for the treatment of visceral leishmaniasis (VL) in India.
Detailed Summary:
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 for a total for a total of 15 doses over 30 days in the treatment of VL in Bihar, India (protocol VLPM01) in a recently completed study (94.6% vs. 98.8% of subjects were disease free at 6 months, respectively). This new study is being conducted to determine whether similar or better efficacy and safety of IM paromomycin can be achieved with a shorter duration of treatment (14 days rather than 21 days) administered for a shorter duration (14 days rather than 21 days) than the regimen studied in the previous trial.
This shorter duration study will compare the initial and final cure (response to treatment) rates in subjects with VL receiving paromomycin at the following doses and dose regimens:
- Group A: paromomycin 11 mg/kg/day IM for 14 days
- Group B: paromomycin 11 mg/kg/day IM for 21 days
Because compliance generally improves with shorter duration of therapy, and better treatment compliance decreases the probability of the emergence of drug-resistant disease, administration of higher daily doses of paromomycin for a shorter time may improve efficacy without producing unacceptable toxicity. In addition, a treatment regimen of shorter duration would cost less and be easier to administer.
The current study is designed to explore different doses and dose regimens of IM paromomycin to determine the dose and dose regimen that should be recommended for first-line therapy for treatment of VL, while maintaining the efficacy and safety.
Sponsor: Banaras Hindu University
Current Primary Outcome: Final Cure [ Time Frame: 6 months after the end of treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Initial cure [ Time Frame: End of treatment ]
Original Secondary Outcome: Same as current
Information By: Banaras Hindu University
Dates:
Date Received: February 20, 2008
Date Started: February 2008
Date Completion:
Last Updated: September 11, 2008
Last Verified: September 2008
