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

This study has been completed.
Sponsor:
Information provided by:
Banaras Hindu University
ClinicalTrials.gov Identifier:
NCT00629031
First received: February 20, 2008
Last updated: September 11, 2008
Last verified: September 2008
  Purpose

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 Intervention Phase
Visceral Leishmaniasis
Drug: Paromomycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Banaras Hindu University:

Primary Outcome Measures:
  • Final Cure [ Time Frame: 6 months after the end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Initial cure [ Time Frame: End of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 329
Study Start Date: February 2008
Study Completion Date: August 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   5 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Banaras Hindu University

Additional 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
Study First Received: February 20, 2008
Last Updated: September 11, 2008
Health Authority: India: Ministry of Health

Keywords provided by Banaras Hindu University:
Visceral leishmaniasis
Paromomycin

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

ClinicalTrials.gov processed this record on October 23, 2014