Condition category
Infections and Infestations
Date applied
05/04/2005
Date assigned
07/06/2005
Last edited
15/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Juntra Karbwang

ORCID ID

Contact details

20
Avenue Appia
Geneva -27
CH 1211
Switzerland
karbwangj@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00216346

Protocol/serial number

A20643, A20485, A20648, A20599

Study information

Scientific title

Acronym

Study hypothesis

The aim of this trial is to assess the safety and efficacy of injectable paromomycin in patients with Visceral Leishmaniasis (VL).

Ethics approval

The protocol was approved by the independent ethics committee at each of the four participating centers, the Drug Controller General of India, and the Steering Committee on Research Involving Human Subjects of the World Health Organization.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Visceral leishmaniasis (VL)

Intervention

Intervention group (500 patients):
Injectable paromomycin sulphate 15 mg/kg intramuscular per day x 30 days.

Control group (167 patients):
Injectable amphotericin B 1 mg/kg continuous intravenous infusion every other day, total 15 doses.

Intervention type

Drug

Phase

Phase III

Drug names

Paromomycin, amphotericin B

Primary outcome measures

Safety:
1. Reported adverse events
2. Protocol-defined nephrotoxicity and ototoxicity
3. Laboratory evaluations
4. Vital signs

Secondary outcome measures

Efficacy:
1. Parasite density
2. Final cure
3. Relapse
4. Treatment failure

Overall trial start date

23/05/2003

Overall trial end date

30/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 5 to 55 years (inclusive) of either gender
2. Confirmed diagnosis by spleen or bone marrow aspirate
3. Clinical signs and symptoms compatible with VL
4. Lab tests:
4.1. Haemoglobin more than 5.0/100 ml
4.2. White Blood Cell (WBC) count more than 1 x 10^9 l
4.3. Platelet count more than 50 x 10^9 l
4.4. Aspartate transaminase (AST), alanine transaminase (ALT) and Alkaline Phosphatase less than three times upper normal limit
4.5. Prothrombin time less than five seconds above control
4.6. Serum creatinine within normal limits
4.7. Serum potassium within normal limits
5. Human Immunodeficiency Virus (HIV) negative

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

667

Participant exclusion criteria

1. History of intercurrent or concurrent diseases that may introduce variable that affect the outcome of the study
2. Any condition which the investigator thinks may prevent the patient from completing the study therapy
3. An abnormal baseline audiogram and/or a history of vestibular or auditory dysfunction
4. Proteinuria (more than 2 g/day)
5. A history of hypersensitivity or allergy to aminoglycosides
6. History of major surgery within last two weeks
7. Pregnancy or lactation
8. Previous treatment for VL within two weeks of enrolment into the study
9. Prior treatment failures with paromomycin or amphotericin B

Recruitment start date

23/05/2003

Recruitment end date

30/06/2003

Locations

Countries of recruitment

India

Trial participating centre

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Sponsor information

Organisation

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)

Sponsor details

20
Avenue Appia
Geneva -27
CH 1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/17582067

Publication citations

  1. Results

    Sundar S, Jha TK, Thakur CP, Sinha PK, Bhattacharya SK, Injectable paromomycin for Visceral leishmaniasis in India., N. Engl. J. Med., 2007, 356, 25, 2571-2581, doi: 10.1056/NEJMoa066536.

Additional files

Editorial Notes