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Status:

COMPLETED

Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis

Lead Sponsor:

PATH

Collaborating Sponsors:

World Health Organization

Conditions:

Visceral Leishmaniasis

Eligibility:

All Genders

5-55 years

Phase:

PHASE3

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 o...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 1 2003

Trial Type :

INTERVENTIONAL

End Date :

November 1 2004

Estimated Enrollment :

667 Patients enrolled

Trial Details

Trial ID

NCT00216346

Start Date

June 1 2003

End Date

November 1 2004

Last Update

October 3 2014

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Rajendra Memorial Research Institute of Medical Sciences (ICMR)

Agam Kuan, Patna, Bihar, India, 800 007

2

Kalazar Research Centre

Brahmpura, Muzaffarpur, Bihar, India, 842003

3

Kalazar Research Centre

Patna, Bihar, India, 800001

4

Kala-azar Medical Research Centre

Rambagh Road Muzaffarpur, Bihar, India, 842001