Impact of Insecticide Resistance on Vector Control
1 other identifier
interventional
28,000
1 country
3
Brief Summary
The purpose of the study is to determine whether long lasting insecticidal nets and indoor residual insecticide spraying, alone or in combination, are effective for controlling insecticide resistant anopheles mosquitoes for malaria prevention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2011
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 22, 2012
CompletedFirst Posted
Study publicly available on registry
October 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 26, 2012
October 1, 2012
3.5 years
October 22, 2012
October 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Malaria Incidence
Infection with malarial parasites determined by rapid diagnostic tests/microscopy in cohort members who report or have fever (\>37.5C)
3 years
Secondary Outcomes (3)
Prevalence of P.falciparum Infection
3 years
Entomological Innoculation rate
Average for months Sept, Oct, Nov for years 2011, 2012, 2013
Frequency of insecticide resistance associated genotypes (kdr) in anopheles arabiensis
Yearly average 2011, 2012, 2013, 2014
Study Arms (2)
Universal coverage of Long Lasting Insecticidal Nets (LLIN)
ACTIVE COMPARATORDistribution of long lasting insecticidal nets to all community members in the study arm allowing for at least one net per 2 persons
LLIN Plus Indoor Residual Spraying
EXPERIMENTALDistribution of long lasting insecticidal nets to all community members in the study arm allowing for at least one net per 2 persons plus indoor residual spraying with insecticide of interior walls of all houses twice yearly.
Interventions
Application of insecticide to interior walls of domiciliary structures to kill malaria vector mosquitoes which rest on walls after taking human blood meal
Provision of LLIN to all community members in the clusters allocated to the study arm. LLIN protect individuals from bites by malaria vector mosquitoes by providing a physical barrier and insecticidal and repellent effect.
Eligibility Criteria
You may qualify if:
- Children older than 6 months and younger than 10 years in approximately 100 randomly selected households in all 140 study clusters selected in the four study areas
You may not qualify if:
- Children living in households within 1 km from the edge of a neighbouring cluster (the buffer zone)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London School of Hygiene and Tropical Medicinelead
- Federal Ministry of Health, Sudancollaborator
- World Health Organizationcollaborator
- Liverpool School of Tropical Medicinecollaborator
Study Sites (3)
Malaria Control Programme
Wad Medani, Al Jazirah, Sudan
Malaria Control Programme
Gedarif, Gedarif State, Sudan
Malaria Control Programme
Kassala, Kassala, Sudan
Related Publications (1)
Kafy HT, Ismail BA, Mnzava AP, Lines J, Abdin MSE, Eltaher JS, Banaga AO, West P, Bradley J, Cook J, Thomas B, Subramaniam K, Hemingway J, Knox TB, Malik EM, Yukich JO, Donnelly MJ, Kleinschmidt I. Impact of insecticide resistance in Anopheles arabiensis on malaria incidence and prevalence in Sudan and the costs of mitigation. Proc Natl Acad Sci U S A. 2017 Dec 26;114(52):E11267-E11275. doi: 10.1073/pnas.1713814114. Epub 2017 Dec 11.
PMID: 29229808DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Immo Kleinschmidt, PhD
London School of Hygiene and Tropical Medicine
- PRINCIPAL INVESTIGATOR
Martin J Donnelly, PhD
Liverpool School of Tropical Medicine
- STUDY DIRECTOR
Khalid A Elmardi, MD
Federal Ministry of Health, Sudan
- PRINCIPAL INVESTIGATOR
Hmooda T Kafy, MSc
Federal Ministry of Health, Sudan
- PRINCIPAL INVESTIGATOR
Bashir A Ismail, MSc
Federal Ministry of Health, Sudan
- PRINCIPAL INVESTIGATOR
Mohamed Ahmed A Mohamed, MSc
Federal Ministry of Health, Sudan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2012
First Posted
October 24, 2012
Study Start
April 1, 2011
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
October 26, 2012
Record last verified: 2012-10