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

This study has been completed.
Sponsor:
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
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00318721
First received: April 25, 2006
Last updated: November 3, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention
Visceral Leishmaniasis
Kala Azar
Device: Long Lasting Impregnated Nets (LLIN)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • L. donovani infection [ Time Frame: yearly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Kala Azar cases [ Time Frame: quarterly ] [ Designated as safety issue: No ]

Enrollment: 20000
Study Start Date: June 2006
Study Completion Date: November 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Device: Long Lasting Impregnated Nets (LLIN)
Distribution of LLIN in selected clusters
No Intervention: control Device: Long Lasting Impregnated Nets (LLIN)
Distribution of LLIN in selected clusters

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318721

Locations
India
Kala Azar Medical Research Center
Muzaffarpur, Bihar, India
Nepal
B P Koirala Institute of Health Sciences
Dharan, Nepal
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
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
Investigators
Principal Investigator: 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, UK
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 (BHU),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
  More Information

No publications provided

Responsible Party: Prof Marleen Boelaert, Institute of Tropical Medicine
ClinicalTrials.gov Identifier: NCT00318721     History of Changes
Other Study ID Numbers: CT-2005-015374
Study First Received: April 25, 2006
Last Updated: November 3, 2009
Health Authority: Nepal: B.P. Koirala Institute of Health Sciences
India: Indian Council of Medical Research

Keywords provided by London School of Hygiene and Tropical Medicine:
Leishmania donovani
cluster-randomised control trial
Long Lasting Impregnated Nets
Bednets
Sandflies

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Parasitic

ClinicalTrials.gov processed this record on November 27, 2014