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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00318721
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : November 4, 2009
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

Tracking Information
First Submitted Date  ICMJE April 25, 2006
First Posted Date  ICMJE April 27, 2006
Last Update Posted Date November 4, 2009
Study Start Date  ICMJE June 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2008)
L. donovani infection [ Time Frame: yearly ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 25, 2006)
L. donovani infection
Change History Complete list of historical versions of study NCT00318721 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2008)
Kala Azar cases [ Time Frame: quarterly ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2006)
Kala Azar cases
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar
Official Title  ICMJE Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Visceral Leishmaniasis
  • Kala Azar
Intervention  ICMJE Device: Long Lasting Impregnated Nets (LLIN)
Distribution of LLIN in selected clusters
Study Arms  ICMJE
  • Experimental: Intervention
    Intervention: Device: Long Lasting Impregnated Nets (LLIN)
  • No Intervention: control
    Intervention: Device: Long Lasting Impregnated Nets (LLIN)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2008)
20000
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India,   Nepal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00318721
Other Study ID Numbers  ICMJE CT-2005-015374
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Marleen Boelaert, Institute of Tropical Medicine
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE
  • 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  ICMJE
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
PRS Account London School of Hygiene and Tropical Medicine
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP