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

NCT ID: NCT00318721

Last Updated: 2009-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-11-30

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.

Conditions

Visceral Leishmaniasis; Kala Azar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Long Lasting Impregnated Nets (LLIN)

Intervention Type: DEVICE

Distribution of LLIN in selected clusters

control

Group Type: NO_INTERVENTION

Long Lasting Impregnated Nets (LLIN)

Intervention Type: DEVICE

Distribution of LLIN in selected clusters

Interventions

Long Lasting Impregnated Nets (LLIN)

Distribution of LLIN in selected clusters

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

Rajendra Memorial Research Institute of Medical Sciences

OTHER

Sponsor Role: collaborator

Institute of Medical Sciences of the Banaras Hindu University, India

OTHER

Sponsor Role: collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: collaborator

B.P. Koirala Institute of Health Sciences

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Institute of Tropical Medicine

Principal Investigators

Marleen Boelaert, Dr

Role: PRINCIPAL_INVESTIGATOR

Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium

Clive Davies, Dr.

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Jean Claude Dujardin, Dr

Role: PRINCIPAL_INVESTIGATOR

Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium

Suman Rijal, Dr.

Role: PRINCIPAL_INVESTIGATOR

B.P. Koirala Institute of Heath Sciences, Nepal

Shyam Sundar, Dr

Role: PRINCIPAL_INVESTIGATOR

Institute of Medical Sciences of the Banaras Hindu University, India

Francois Chappuis, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Beena Varghese, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre for Health and Population Research (ICDDR,B), Dhaka, Bangladesh

Marc Coosemans, Dr

Role: PRINCIPAL_INVESTIGATOR

Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium.

Veerle Vanlerberghe, Dr.

Role: PRINCIPAL_INVESTIGATOR

Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium.

Diwarkar Dinesh, Dr

Role: PRINCIPAL_INVESTIGATOR

Rajendra Memorial Research Institute of Medical Sciences

Locations

Kala Azar Medical Research Center

Muzaffarpur, Bihar, India

B P Koirala Institute of Health Sciences

Dharān, , Nepal

Countries

India; Nepal

References

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.

Reference Type: DERIVED

PMID: 20126269 (View on PubMed)

Other Identifiers

CT-2005-015374

Identifier Type: -

Identifier Source: org_study_id