Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

December 13, 2005

Start Date ^†

June 2003

Current 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.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00216346 on ClinicalTrials.gov Archive Site

Current 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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis

Official Title ^†

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

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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Visceral Leishmaniasis

Intervention ^†

Drug: Paromomycin sulfate
Drug: Amphotericin B

Study Arms / Comparison Groups

Publications *

Sundar S, Jha TK, Thakur CP, Sinha PK, Bhattacharya SK. Injectable paromomycin for Visceral leishmaniasis in India. N Engl J Med. 2007 Jun 21;356(25):2571-81.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

667

Completion Date

November 2004

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

5 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

India

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00216346

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Institute for OneWorld Health

Collaborators ^††

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)

Information Provided By

Institute for OneWorld Health

Verification Date

September 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.