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| Sponsor: | London School of Hygiene and Tropical Medicine |
|---|---|
| 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 |
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 |
| 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 |
Inclusion criteria (Clusters):
Exclusion criteria (Clusters):
Contacts and Locations| India | |
| Kala Azar Medical Research Center | |
| Muzaffarpur, Bihar, India | |
| Nepal | |
| B P Koirala Institute of Health Sciences | |
| Dharan, Nepal | |
| 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
| 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 |
|
Leishmania donovani cluster-randomised control trial Long Lasting Impregnated Nets Bednets Sandflies |
|
Leishmaniasis Leishmaniasis, Visceral Euglenozoa Infections Protozoan Infections |
Parasitic Diseases Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases |