Ignite Creation Date:
2024-05-05 @ 7:13 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00629031
Status:
COMPLETED
Last Update Posted:
2008-09-12
First Post:
2008-02-20
Brief Title:
An Open Lable Randomised Study to Assess the Safety and Efficacy of Short Course Paromomycin in Visceral Leishmaniasis
Sponsor:
Banaras Hindu University
Organization:
Banaras Hindu University
Study Overview
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 Indian Visceral Leishmaniasis VL
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is a randomized double-blind multi-center two-arm study intended to assess the safety and efficacy of three different dosesdose regimens of paromomycin administered intramuscularly as follows 11 mgkgday for 14 days and 11 mgkgday for 21 days for the treatment of visceral leishmaniasis VL in India
Detailed Description:
Paromomycin administered at a dose of 11 mgkgday 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 mgkgevery 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 946 vs 988 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 mgkgday IM for 14 days
Group B paromomycin 11 mgkgday 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
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 mgkgday IM for 14 days
Group B paromomycin 11 mgkgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None