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Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis

Phase 3
Completed
Conditions
Visceral Leishmaniasis
Registration Number
NCT00216346
Lead Sponsor
PATH
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
667
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
(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
NameTimeMethod
- 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

Trial Locations

Locations (3)

Rajendra Memorial Research Institute of Medical Sciences (ICMR)

🇮🇳

Agam Kuan, Patna, Bihar, India

Kalazar Research Centre

🇮🇳

Patna, Bihar, India

Kala-azar Medical Research Centre

🇮🇳

Rambagh Road Muzaffarpur, Bihar, India

Rajendra Memorial Research Institute of Medical Sciences (ICMR)
🇮🇳Agam Kuan, Patna, Bihar, India

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