Clinical trial NCT00318721: Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar
Official title: Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visceral Leishmaniasis
Kala Azar
Keywords: Leishmania donovani
cluster-randomised control trial
Long Lasting Impregnated Nets
Bednets
Sandflies
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Institute of Tropical Medicine, Belgium
name: University Hospital, Geneva
name: Rajendra Memorial Research Institute of Medical Sciences
name: Institute of Medical Sciences of the Banaras Hindu University (BHU),India
name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: B.P. Koirala Institute of Health Sciences
First posted: 2006-04-27
Enrollment: 20000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: L. donovani infection
timeFrame: yearly
Secondary outcomes:
measure: Kala Azar cases
timeFrame: quarterly
Other outcomes:
Locations:
city: Muzaffarpur
country: India
facility: Kala Azar Medical Research Center
state: Bihar
city: Dharan
country: Nepal
facility: B P Koirala Institute of Health Sciences
Study officials:
affiliation: Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium
name: Marleen Boelaert, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Clive Davies, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium
name: Jean Claude Dujardin, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: B.P. Koirala Institute of Heath Sciences, Nepal
name: Suman Rijal, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Medical Sciences of the Banaras Hindu University (BHU),India
name: Shyam Sundar, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Geneva
name: Francois Chappuis, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Health and Population Research (ICDDR,B), Dhaka, Bangladesh
name: Beena Varghese, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium.
name: Marc Coosemans, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium.
name: Veerle Vanlerberghe, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rajendra Memorial Research Institute of Medical Sciences
name: Diwarkar Dinesh, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.