NCT00604955

Brief Summary

This modular Program will first confirm the safety and efficacy of Paromomycin IM Injection when given to an expanded population in the outpatient setting in experienced VL centers and subsequently evaluate the effectiveness of an expanded access model of providing Paromomycin IM Injection to progressively more resource-constrained clinics in Bihar, India.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2007

Typical duration for phase_4

Geographic Reach
1 country

7 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

October 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

October 3, 2014

Status Verified

October 1, 2014

Enrollment Period

1.2 years

First QC Date

January 17, 2008

Last Update Submit

October 2, 2014

Conditions

Visceral Leishmaniasis

Keywords

visceral leishmaniasiskala-azarBihar, India

Outcome Measures

Primary Outcomes (2)

  • M1: Safety as measured by adverse events, serious adverse events, vital signs, and laboratory parameters.

    M1: Approximately 6 months

  • M2&3: Program effectiveness as measured by specific criteria for healthcare workers, patients, and operational systems.

    approximately 2.5 years

Secondary Outcomes (2)

  • M1: Clinical cure as measured by temperature/hx of fever, spleen size decrease by at least 33% from baseline, and clinical assessment of treating physician.

    M1: Approximately 6 months

  • M2 and M3: Clinical cure as measured by temperature/hx of fever, spleen size decrease, and clinical assessment of treating physician.

    approximately 6 months

Study Arms (1)

A

EXPERIMENTAL

Paromomycin IM Injection (approved product in India)

Drug: Paromomycin sulfate

Interventions

Paromomycin sulfateDRUG

Paromomycin will be administered intramuscularly at 11 mg/kg, once a day, for 21 consecutive days

Also known as: Paromomycin IM Injection
A

Eligibility Criteria

Age2 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Confirmed, newly diagnosed or relapsed visceral leishmaniasis

You may not qualify if:

  • HIV infection, tuberculosis
  • Significant hematologic, renal or liver dysfunction
  • Malaria
  • Those unable to be treated as an outpatient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Rajendra Memorial Research Institute of Medical Sciences

Agam Kuan, Patna, Bihar, 800 007, India

Location

Shrimati Hazari Maternity and Medical Care

Azad Nagar, Balua Tal, Motihari, Bihar, 845 401, India

Location

Research Centre for Diabetes, Hypertension and Obesity

Bengali Tola, Samastipur, Bihar, 848 101, India

Location

Dr. A.K. Aditya Clinic

East of Bhola Talkies, Samastipur, Bihar, 848 101, India

Location

Kala-zar Research Centre

Patna, Bihar, 800 001, India

Location

Kala-azar Medical Research Centre

Rambagh Road, Muzaffarpur, Bihar, 842 001, India

Location

Kalazar Research Centre

Brahmpura, Muzaffarpur, Bihar, 842 003, 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: 17582067BACKGROUND

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

Paromomycin

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydrates

Study Officials

  • P K Sinha, MD

    Rajendra Memorial Research Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • T K Jha, MD

    Kalazar Research Centre

    PRINCIPAL INVESTIGATOR

  • C P Thakur, MD

    Kala-azar Research Centre

    PRINCIPAL INVESTIGATOR

  • Shyam Sundar, MD

    Kala-azar Medical Research Centre

    PRINCIPAL INVESTIGATOR

  • Devendra Nath, MD

    Shrimati Hazari Maternity and Medical Care

    PRINCIPAL INVESTIGATOR

  • Supriyo Mukherjee, MD

    Research Centre for Diabetes, Hypertension and Obesity

    PRINCIPAL INVESTIGATOR

  • Amrendra K Aditya, MD

    Dr. A.K. Aditya Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2008

First Posted

January 30, 2008

Study Start

October 1, 2007

Primary Completion

December 1, 2008

Study Completion

January 1, 2010

Last Updated

October 3, 2014

Record last verified: 2014-10

Locations

IN(7)