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

Visceral Leishmaniasis Clinical Trial

— KALANET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318721
• Other study ID #: CT-2005-015374
• Status: Completed
• Phase: N/A
• First received: April 25, 2006
• Last updated: November 3, 2009
• Start date: June 2006
• Est. completion date: November 2009

Study information

• Verified date: June 2009
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Nepal: B.P. Koirala Institute of Health SciencesIndia: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20000
• Est. completion date: November 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kala Azar
• Leishmaniasis
• Leishmaniasis, Visceral
• Visceral Leishmaniasis

Intervention

Device:
• Long Lasting Impregnated Nets (LLIN)
Distribution of LLIN in selected clusters

Locations

Country	Name	City	State
India	Kala Azar Medical Research Center	Muzaffarpur	Bihar
Nepal	B P Koirala Institute of Health Sciences	Dharan

Sponsors (7)

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

Countries where clinical trial is conducted

India,  Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	L. donovani infection		yearly	Yes
Secondary	Kala Azar cases		quarterly	No