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

NCT00318721 | Completed DMC

• 1 other identifier: CT-2005-015374
• Study Type: interventional
• Target: 20,000
• Locations: 2 countries
• Sites: 2

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

Keywords

Leishmania donovani; cluster-randomised control trial; Long Lasting Impregnated Nets; Bednets; Sandflies

Outcome Measures

Primary Outcomes (1)

• L. donovani infection

  yearly

Secondary Outcomes (1)

• Kala Azar cases

  quarterly

Study Arms (2)

Intervention

EXPERIMENTAL

Device: Long Lasting Impregnated Nets (LLIN)

control

NO INTERVENTION

Device: Long Lasting Impregnated Nets (LLIN)

Interventions

Long Lasting Impregnated Nets (LLIN) DEVICE

Distribution of LLIN in selected clusters

Intervention; control

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Institute of Tropical Medicine, Belgium: collaborator
• University Hospital, Geneva: collaborator
• Rajendra Memorial Research Institute of Medical Sciences: collaborator
• Institute of Medical Sciences of the Banaras Hindu University, India: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• B.P. Koirala Institute of Health Sciences: collaborator

Study Sites (2)

Kala Azar Medical Research Center

Muzaffarpur, Bihar, India

Location

B P Koirala Institute of Health Sciences

Dharān, Nepal

Location

Related Publications (1)

• 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.

  PMID: 20126269 DERIVED

MeSH Terms

Conditions

Leishmaniasis, Visceral

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• 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, 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 25, 2006
• First Posted: April 27, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: November 1, 2009
• Last Updated: November 4, 2009

Record last verified: 2009-06

Locations

NE (1); IN (1)