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

Primary Purpose

Visceral Leishmaniasis, Kala Azar

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Long Lasting Impregnated Nets (LLIN)
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Visceral Leishmaniasis focused on measuring Leishmania donovani, cluster-randomised control trial, Long Lasting Impregnated Nets, Bednets, Sandflies

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria (Clusters): at least have seen 1 case per year in each of the last 3 years An average of at least 1% Incidence rate over the period of past 3 years. Exclusion criteria (Clusters): Minimum 500 people Maximum 2000 people Distance between clusters 2000 meters (distance between borders) Houses in tola/ward not sprayed (DDT, other) in 2006 Accessibility

Sites / Locations

  • Kala Azar Medical Research Center
  • B P Koirala Institute of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

control

Arm Description

Outcomes

Primary Outcome Measures

L. donovani infection

Secondary Outcome Measures

Kala Azar cases

Full Information

First Posted
April 25, 2006
Last Updated
November 3, 2009
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Institute of Tropical Medicine, Belgium, University Hospital, Geneva, Rajendra Memorial Research Institute of Medical Sciences, Institute of Medical Sciences of the Banaras Hindu University (BHU),India, International Centre for Diarrhoeal Disease Research, Bangladesh, B.P. Koirala Institute of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00318721
Brief Title
Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar
Acronym
KALANET
Official Title
Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visceral Leishmaniasis, Kala Azar
Keywords
Leishmania donovani, cluster-randomised control trial, Long Lasting Impregnated Nets, Bednets, Sandflies

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Long Lasting Impregnated Nets (LLIN)
Intervention Description
Distribution of LLIN in selected clusters
Primary Outcome Measure Information:
Title
L. donovani infection
Time Frame
yearly
Secondary Outcome Measure Information:
Title
Kala Azar cases
Time Frame
quarterly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria (Clusters): at least have seen 1 case per year in each of the last 3 years An average of at least 1% Incidence rate over the period of past 3 years. Exclusion criteria (Clusters): Minimum 500 people Maximum 2000 people Distance between clusters 2000 meters (distance between borders) Houses in tola/ward not sprayed (DDT, other) in 2006 Accessibility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marleen Boelaert, Dr
Organizational Affiliation
Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Clive Davies, Dr.
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Claude Dujardin, Dr
Organizational Affiliation
Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suman Rijal, Dr.
Organizational Affiliation
B.P. Koirala Institute of Heath Sciences, Nepal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shyam Sundar, Dr
Organizational Affiliation
Institute of Medical Sciences of the Banaras Hindu University (BHU),India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francois Chappuis, Dr.
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Beena Varghese, Dr
Organizational Affiliation
Centre for Health and Population Research (ICDDR,B), Dhaka, Bangladesh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Coosemans, Dr
Organizational Affiliation
Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Veerle Vanlerberghe, Dr.
Organizational Affiliation
Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Diwarkar Dinesh, Dr
Organizational Affiliation
Rajendra Memorial Research Institute of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kala Azar Medical Research Center
City
Muzaffarpur
State/Province
Bihar
Country
India
Facility Name
B P Koirala Institute of Health Sciences
City
Dharan
Country
Nepal

12. IPD Sharing Statement

Citations:
PubMed Identifier
20126269
Citation
Picado A, Das ML, Kumar V, Kesari S, Dinesh DS, Roy L, Rijal S, Das P, Rowland M, Sundar S, Coosemans M, Boelaert M, Davies CR. Effect of village-wide use of long-lasting insecticidal nets on visceral Leishmaniasis vectors in India and Nepal: a cluster randomized trial. PLoS Negl Trop Dis. 2010 Jan 26;4(1):e587. doi: 10.1371/journal.pntd.0000587.
Results Reference
derived

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

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