Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis

Visceral Leishmaniasis Clinical Trial

Official title:

A Phase 3 Multicenter, Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Injectable Paromomycin in Patients With Visceral Leishmaniasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216346
• Other study ID #: VLPM01
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: October 2, 2014
• Start date: June 2003
• Est. completion date: November 2004

Study information

• Verified date: October 2014
• Source: PATH
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral
• Visceral Leishmaniasis

Intervention

Drug:
• Paromomycin sulfate

• Amphotericin B

Locations

Country	Name	City	State
India	Rajendra Memorial Research Institute of Medical Sciences (ICMR)	Agam Kuan, Patna	Bihar
India	Kalazar Research Centre	Brahmpura, Muzaffarpur	Bihar
India	Kalazar Research Centre	Patna	Bihar
India	Kala-azar Medical Research Centre	Rambagh Road Muzaffarpur	Bihar

Sponsors (2)

Lead Sponsor	Collaborator
PATH	World Health Organization

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(1) To compare the safety of injectable paromomycin to amphotericin B when administered in the proposed dosage regimens.
Primary	(2) To compare the efficacy of injectable paromomycin to amphotericin B with regards to final cure rates.
Secondary	- Characterization of the pharmacokinetics of injectable paromomycin in adults and children with VL
Secondary	- Comparison of initial cure rates for the two regimens
Secondary	- Comparison of clinical improvement rates for the two regimens

External Links

•   Institute for OneWorld Health--A Nonprofit Pharmaceutical Company