Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis
Information source: Institute for OneWorld Health
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Visceral Leishmaniasis
Intervention: Paromomycin sulfate (Drug); Amphotericin B (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Institute for OneWorld Health Official(s) and/or principal investigator(s):
Prof S. Sundar, Principal Investigator, Affiliation: Kala-azar Research Centre
Prof T.K. Jha, Principal Investigator, Affiliation: Kalazar Research Centre
Prof C.P. Thakur, Principal Investigator, Affiliation: Kalazar Research Centre
Dr. S.K. Bhattacharya, Principal Investigator, Affiliation: Rajendra Memorial Research Institute of Medical Sciences (ICMR)
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.
Clinical Details
Official title: A Phase 3 Multicenter, Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Injectable Paromomycin in Patients With Visceral Leishmaniasis
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: (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: - 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
Eligibility
Minimum age: 5 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Kalazar Research Centre, Brahmpura, Muzaffarpur, Bihar 842003, India
Kala-azar Medical Research Centre, Rambagh Road Muzaffarpur, Bihar 842001, India
Kalazar Research Centre, Balaji Utthan Sanastan, Fraser Road "Uma Complex" Patna, Bihar 800001, India
Rajendra Memorial Research Institute of Medical Sciences (ICMR), AGAM KUAN, Patna, Bihar 800 007, India
Additional Information
Institute for OneWorld Health--A Nonprofit Pharmaceutical Company
Starting date: June 2003
Ending date: November 2004
Last updated: December 13, 2005
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