Impact of Insecticide Resistance on Vector Control
Primary Purpose
Malaria, Falciparum
Status
Unknown status
Phase
Phase 4
Locations
Sudan
Study Type
Interventional
Intervention
Indoor residual insecticide spraying (IRS)
Long Lasting Insecticidal Nets (LLIN)
Sponsored by
About this trial
This is an interventional prevention trial for Malaria, Falciparum focused on measuring Mosquito Control, Insecticide Resistance
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Children living in households within 1 km from the edge of a neighbouring cluster (the buffer zone)
Sites / Locations
- Malaria Control ProgrammeRecruiting
- Malaria Control ProgrammeRecruiting
- Malaria Control ProgrammeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Universal coverage of Long Lasting Insecticidal Nets (LLIN)
LLIN Plus Indoor Residual Spraying
Arm Description
Distribution of long lasting insecticidal nets to all community members in the study arm allowing for at least one net per 2 persons
Distribution 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.
Outcomes
Primary Outcome Measures
Malaria Incidence
Infection with malarial parasites determined by rapid diagnostic tests/microscopy in cohort members who report or have fever (>37.5C)
Secondary Outcome Measures
Prevalence of P.falciparum Infection
Infection with plasmodial parasites (falciparum and/or vivax) in randomly selected members of the study cohort in each study cluster during the peak of the malaria transmission season by rapid diagnostic test
Entomological Innoculation rate
Anopheles arabiensis mosquitoes collected in sentinel clusters by light trap, window trap, clay pot and pyrethrum sheet collection and determination of sporozoite, human blood index, feeding and resting behaviour.
Frequency of insecticide resistance associated genotypes (kdr) in anopheles arabiensis
Molecular analysis of mosquito specimens caught in subset of clusters by pyrethrum spray collection.
Full Information
NCT ID
NCT01713517
First Posted
October 22, 2012
Last Updated
October 25, 2012
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Federal Ministry of Health, Sudan, World Health Organization, Liverpool School of Tropical Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01713517
Brief Title
Impact of Insecticide Resistance on Vector Control
Official Title
Impact of Insecticide Resistance in Anopheles Arabiensis on the Effectiveness of Malaria Vector Control in Sudan
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Federal Ministry of Health, Sudan, World Health Organization, Liverpool School of Tropical Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The study will assess the impact that insecticide resistance has on the effectiveness of malaria vector control tools LLIN and IRS. This is done by a cluster randomised trials of universal coverage LLINs versus universal coverage LLINs in combination with IRS, with levels of baseline insecticide resistance in the main vector balanced between the two study arms. In each cluster resistance to the insecticide used on LLINs is monitored, and malaria incidence is estimated from cluster specific cohorts of children followed up over the duration of the study. Resistance impact will be assessed from the ratio of incidence rates in clusters with high compared to those with low resistance and from a continuous measure of resistance expressed as percentage loss of mosquito mortality when exposed to insecticide in standardised WHO tests. Resistance mechanisms will be studied in subsets of study clusters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Falciparum
Keywords
Mosquito Control, Insecticide Resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Universal coverage of Long Lasting Insecticidal Nets (LLIN)
Arm Type
Active Comparator
Arm Description
Distribution of long lasting insecticidal nets to all community members in the study arm allowing for at least one net per 2 persons
Arm Title
LLIN Plus Indoor Residual Spraying
Arm Type
Experimental
Arm Description
Distribution 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.
Intervention Type
Other
Intervention Name(s)
Indoor residual insecticide spraying (IRS)
Other Intervention Name(s)
IRS, Pesticide, Bendiocarb, Deltamethrin
Intervention Description
Application of insecticide to interior walls of domiciliary structures to kill malaria vector mosquitoes which rest on walls after taking human blood meal
Intervention Type
Device
Intervention Name(s)
Long Lasting Insecticidal Nets (LLIN)
Other Intervention Name(s)
Insecticide Treated Nets (ITN), Permanet2.0
Intervention Description
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.
Primary Outcome Measure Information:
Title
Malaria Incidence
Description
Infection with malarial parasites determined by rapid diagnostic tests/microscopy in cohort members who report or have fever (>37.5C)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Prevalence of P.falciparum Infection
Description
Infection with plasmodial parasites (falciparum and/or vivax) in randomly selected members of the study cohort in each study cluster during the peak of the malaria transmission season by rapid diagnostic test
Time Frame
3 years
Title
Entomological Innoculation rate
Description
Anopheles arabiensis mosquitoes collected in sentinel clusters by light trap, window trap, clay pot and pyrethrum sheet collection and determination of sporozoite, human blood index, feeding and resting behaviour.
Time Frame
Average for months Sept, Oct, Nov for years 2011, 2012, 2013
Title
Frequency of insecticide resistance associated genotypes (kdr) in anopheles arabiensis
Description
Molecular analysis of mosquito specimens caught in subset of clusters by pyrethrum spray collection.
Time Frame
Yearly average 2011, 2012, 2013, 2014
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Children living in households within 1 km from the edge of a neighbouring cluster (the buffer zone)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hmooda T Kafy, MSc (London)
Phone
+249 123 399 994
Email
hmoodak@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bashir A Ismail, MSc (USM)
Phone
+249 912938842
Email
bashiradam69@yahoo.co.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Immo Kleinschmidt, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin J Donnelly, PhD
Organizational Affiliation
Liverpool School of Tropical Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Khalid A Elmardi, MD
Organizational Affiliation
Federal Ministry of Health, Sudan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hmooda T Kafy, MSc
Organizational Affiliation
Federal Ministry of Health, Sudan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bashir A Ismail, MSc
Organizational Affiliation
Federal Ministry of Health, Sudan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Ahmed A Mohamed, MSc
Organizational Affiliation
Federal Ministry of Health, Sudan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malaria Control Programme
City
Gedarif
State/Province
Gedarif State
Country
Sudan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anwar Banaga, MSc
Phone
+249 122645846
Email
anwrbanaga@yahoo.com
Facility Name
Malaria Control Programme
City
Wad Medani
State/Province
Gezira State
Country
Sudan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sakhr B Elshiekh, MSc
Phone
+249 117587549
Email
sakhr_14@yahoo.com
Facility Name
Malaria Control Programme
City
Kassala
State/Province
Kassala State
Country
Sudan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaaaldeen H Hussein, MSc
Phone
+249 117587536
Email
shaaaldeen64@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
29229808
Citation
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.
Results Reference
derived
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Impact of Insecticide Resistance on Vector Control
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