Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar (KALANET)

November 3, 2009 updated by: London School of Hygiene and Tropical Medicine
A cluster-randomized vector control trial in Bihar, India, and neighboring Nepal, will test the efficacy of long-lasting impregnated bednets (LLINs, Permanets) for reducing visceral leishmaniasis incidence. The intervention unit is the village (400-1000 people). The study is designed to detect a 50% reduction in Leishmania donovani incidence in intervention compared to control clusters over 2 years. 24 clusters (selected as high incidence during previous years) will be randomly allocated to intervention or control. Following health education, and with informed consent, all households in intervention villages will receive free Permanets (from September 2006). Net usage will be monitored and new nets provided if required. Control villages will not be given untreated nets, as - although commonly used in this region - their effectiveness against sandflies has not been proven. Pre-intervention infection status of villagers (>2 yrs) will be evaluated serologically from finger-prick blood (and past/current disease status noted). Incident infections will be recorded by 3-monthly active search for clinical cases, and by annual serological diagnoses to detect subclinical infections. All villagers (>2yrs) will be leishmanin skin tested at the end of the trial for further subclinical infection detection, and sera from a sub-sample will be tested for antibodies to sandfly saliva antigens (a measure of sandfly exposure). All clinical cases will be given free treatment. Free Permanets will be provided to control villages after the trial. Complementary studies involve entomological surveillance by light traps in a sample of houses and social/economic questionnaire surveys. The entomological surveys will test whether community-wide use of LLINs provides any mass effect, which could protect those in the community who fail to use LLIN for any reason.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Bihar
      • Muzaffarpur, Bihar, India
        • Kala Azar Medical Research Center
  • Nepal
      • Dharan, Nepal
        • B P Koirala Institute of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria (Clusters):

  1. at least have seen 1 case per year in each of the last 3 years
  2. An average of at least 1% Incidence rate over the period of past 3 years.

Exclusion criteria (Clusters):

  1. Minimum 500 people
  2. Maximum 2000 people
  3. Distance between clusters 2000 meters (distance between borders)
  4. Houses in tola/ward not sprayed (DDT, other) in 2006
  5. Accessibility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Device: Long Lasting Impregnated Nets (LLIN)
Distribution of LLIN in selected clusters
No Intervention: control
Device: Long Lasting Impregnated Nets (LLIN)
Distribution of LLIN in selected clusters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
L. donovani infection
Time Frame: yearly
yearly

Secondary Outcome Measures

Outcome Measure
Time Frame
Kala Azar cases
Time Frame: quarterly
quarterly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

University Hospital, Geneva
International Centre for Diarrhoeal Disease Research, Bangladesh
Institute of Tropical Medicine, Belgium
B.P. Koirala Institute of Health Sciences
Rajendra Memorial Research Institute of Medical Sciences
Institute of Medical Sciences of the Banaras Hindu University (BHU),India

Investigators

  • Principal Investigator: Marleen Boelaert, Dr, Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium
  • Principal Investigator: Clive Davies, Dr., London School of Hygiene and Tropical Medicine
  • Principal Investigator: Jean Claude Dujardin, Dr, Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium
  • Principal Investigator: Suman Rijal, Dr., B.P. Koirala Institute of Heath Sciences, Nepal
  • Principal Investigator: Shyam Sundar, Dr, Institute of Medical Sciences of the Banaras Hindu University (BHU),India
  • Principal Investigator: Francois Chappuis, Dr., University Hospital, Geneva
  • Principal Investigator: Beena Varghese, Dr, Centre for Health and Population Research (ICDDR,B), Dhaka, Bangladesh
  • Principal Investigator: Marc Coosemans, Dr, Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium.
  • Principal Investigator: Veerle Vanlerberghe, Dr., Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium.
  • Principal Investigator: Diwarkar Dinesh, Dr, Rajendra Memorial Research Institute of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

April 25, 2006

First Submitted That Met QC Criteria

April 25, 2006

First Posted (Estimate)

April 27, 2006

Study Record Updates

Last Update Posted (Estimate)

November 4, 2009

Last Update Submitted That Met QC Criteria

November 3, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-2005-015374

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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