Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis

This study has been completed.
Sponsor:
Collaborator:
World Health Organization
Information provided by:
PATH
ClinicalTrials.gov Identifier:
NCT00216346
First received: September 13, 2005
Last updated: December 13, 2005
Last verified: September 2005
  Purpose

Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.


Condition Intervention Phase
Visceral Leishmaniasis
Drug: Paromomycin sulfate
Drug: Amphotericin B
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: A Phase 3 Multicenter, Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Injectable Paromomycin in Patients With Visceral Leishmaniasis

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • (1) To compare the safety of injectable paromomycin to amphotericin B when administered in the proposed dosage regimens.
  • (2) To compare the efficacy of injectable paromomycin to amphotericin B with regards to final cure rates.

Secondary Outcome Measures:
  • - Characterization of the pharmacokinetics of injectable paromomycin in adults and children with VL
  • - Comparison of initial cure rates for the two regimens
  • - Comparison of clinical improvement rates for the two regimens

Estimated Enrollment: 667
Study Start Date: June 2003
Estimated Study Completion Date: November 2004
  Eligibility

Ages Eligible for Study:   5 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 5-55 years (inclusive) of either gender.
  • Newly diagnosed VL or VL treatment failure confirmed by spleen or bone marrow aspirate.
  • Clinical signs and symptoms compatible with VL: fever of over two weeks duration and splenomegaly.
  • Biochemical and haematological test values as follows:

    • Haemoglobin > 5.0g/100mL
    • White blood cell count > 1 x109/L
    • Platelet count > 50 x 109/L
    • AST, ALT and alkaline phosphatase < 3 times upper normal limit
    • Prothrombin time < 5 seconds above control
    • Serum creatinine levels within normal limits
    • Serum potassium levels within normal limits
  • HIV negative

Exclusion Criteria:

  • A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or central nervous system disease; diabetes; tuberculosis or other infectious or major psychiatric diseases) that may introduce variables affecting the outcome of the study.
  • Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
  • An abnormal baseline audiogram (presentation with 75 dB or higher at 8KHz or below) and/or a history of significant vestibular or auditory dysfunction.
  • Proteinuria (> 2+).
  • A history of allergy or hypersensitivity to aminoglycosides.
  • A history of major surgery within the last two weeks.
  • Pregnancy or lactation. [Note: women of childbearing age must use an adequate form of contraception (documented) or agree to a period of sexual abstinence during the treatment phase of the study.]
  • Previous treatment for VL within two weeks of enrolment into the study.
  • Prior treatment failures with paromomycin or amphotericin B.
  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: NCT00216346

Locations
India
Rajendra Memorial Research Institute of Medical Sciences (ICMR)
AGAM KUAN, Patna, Bihar, India, 800 007
Kalazar Research Centre
Balaji Utthan Sanastan, Fraser Road "Uma Complex" Patna, Bihar, India, 800001
Kalazar Research Centre
Brahmpura, Muzaffarpur, Bihar, India, 842003
Kala-azar Medical Research Centre
Rambagh Road Muzaffarpur, Bihar, India, 842001
Sponsors and Collaborators
PATH
World Health Organization
Investigators
Principal Investigator: Prof S. Sundar Kala-azar Research Centre
Principal Investigator: Prof T.K. Jha Kalazar Research Centre
Principal Investigator: Prof C.P. Thakur Kalazar Research Centre
Principal Investigator: Dr. S.K. Bhattacharya Rajendra Memorial Research Institute of Medical Sciences (ICMR)
  More Information

Additional Information:
No publications provided by PATH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00216346     History of Changes
Other Study ID Numbers: VLPM01
Study First Received: September 13, 2005
Last Updated: December 13, 2005
Health Authority: India: Ministry of Health

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

ClinicalTrials.gov processed this record on September 14, 2014