NCT00216346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
667

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

October 3, 2014

Status Verified

October 1, 2014

First QC Date

September 13, 2005

Last Update Submit

October 2, 2014

Conditions

Visceral Leishmaniasis

Outcome Measures

Primary Outcomes (2)

  • (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 Outcomes (3)

  • - 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

Interventions

Paromomycin sulfateDRUG
Amphotericin BDRUG

Eligibility Criteria

Age5 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rajendra Memorial Research Institute of Medical Sciences (ICMR)

Agam Kuan, Patna, Bihar, 800 007, India

Location

Kalazar Research Centre

Brahmpura, Muzaffarpur, Bihar, 842003, India

Location

Kalazar Research Centre

Patna, Bihar, 800001, India

Location

Kala-azar Medical Research Centre

Rambagh Road Muzaffarpur, Bihar, 842001, India

Location

Related Publications (1)

  • 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. doi: 10.1056/NEJMoa066536.

    PMID: 17582067DERIVED

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

ParomomycinAmphotericin B

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydratesMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

June 1, 2003

Study Completion

November 1, 2004

Last Updated

October 3, 2014

Record last verified: 2014-10

Locations

IN(4)