An Open Lable Randomised Study to Assess the Safety and Efficacy of Short Course Paromomycin in Visceral Leishmaniasis
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)
1 other identifier
interventional
329
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 20, 2008
CompletedFirst Posted
Study publicly available on registry
March 5, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedSeptember 12, 2008
September 1, 2008
Same day
February 20, 2008
September 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Final Cure
6 months after the end of treatment
Secondary Outcomes (1)
Initial cure
End of treatment
Study Arms (2)
2
ACTIVE COMPARATORParomomycin for 21 days @ 11mg/kg
1
EXPERIMENTALParomomycin for 14 days @ 11mg/kg
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kala-azar Medical Research Center, Rambag Road
Varanasi, 842001, India
Related Publications (1)
Sundar S, Agrawal N, Arora R, Agarwal D, Rai M, Chakravarty J. Short-course paromomycin treatment of visceral leishmaniasis in India: 14-day vs 21-day treatment. Clin Infect Dis. 2009 Sep 15;49(6):914-8. doi: 10.1086/605438.
PMID: 19663597DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shyam Sundar, MD
Banaras Hindu University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 20, 2008
First Posted
March 5, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2008
Study Completion
August 1, 2008
Last Updated
September 12, 2008
Record last verified: 2008-09