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An Open Lable Randomised Study to Assess the Safety and Efficacy of Short Course Paromomycin in Visceral Leishmaniasis

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ClinicalTrials.gov Identifier: NCT00629031
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : September 12, 2008
Sponsor:
Information provided by:
Banaras Hindu University

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.

Condition or disease Intervention/treatment Phase
Visceral Leishmaniasis Drug: Paromomycin Phase 3

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 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 329 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : February 2008
Actual Primary Completion Date : February 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 2
Paromomycin for 21 days @ 11mg/kg
Drug: Paromomycin
Paromomycin for 21 days @ 11mg/kg by intramuscular injections
Experimental: 1
Paromomycin for 14 days @ 11mg/kg
Drug: Paromomycin
11 mg/kg for 14 days
Drug: Paromomycin
Paromomycin for 21 days @ 11mg/kg by intramuscular injections



Primary Outcome Measures :
  1. Final Cure [ Time Frame: 6 months after the end of treatment ]

Secondary Outcome Measures :
  1. Initial cure [ Time Frame: End of treatment ]


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Ages Eligible for Study:   5 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629031


Locations
India
Kala-azar Medical Research Center, Rambag Road
Varanasi, India, 842001
Sponsors and Collaborators
Banaras Hindu University
Investigators
Study Director: Shyam Sundar, MD Banaras Hindu University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shyam Sundar, Banaras Hindu University
ClinicalTrials.gov Identifier: NCT00629031     History of Changes
Other Study ID Numbers: KAMRC PSD
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: September 12, 2008
Last Verified: September 2008

Keywords provided by Banaras Hindu University:
Visceral leishmaniasis
Paromomycin

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Paromomycin
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents