Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00318721
Status:
COMPLETED
Last Update Posted:
2009-11-04
First Post:
2006-04-25
Brief Title:
Efficacy Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets LLIN in the Prevention of Kala Azar
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
Efficacy Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets LLIN in the Prevention of Kala Azar
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KALANET
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 pastcurrent 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 socialeconomic 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None