Impact of Insecticide Resistance on Vector Control

October 25, 2012 updated by: London School of Hygiene and Tropical Medicine

Impact of Insecticide Resistance in Anopheles Arabiensis on the Effectiveness of Malaria Vector Control in Sudan

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

28000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hmooda T Kafy, MSc (London)
  • Phone Number: +249 123 399 994
  • Email: hmoodak@yahoo.com

Study Contact Backup

Study Locations

  • Sudan
    • Gedarif State
      • Gedarif, Gedarif State, Sudan
        • Recruiting
        • Malaria Control Programme
        • Contact:
    • Gezira State
      • Wad Medani, Gezira State, Sudan
        • Recruiting
        • Malaria Control Programme
        • Contact:
    • Kassala State
      • Kassala, Kassala State, Sudan
        • Recruiting
        • Malaria Control Programme
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Universal coverage of Long Lasting Insecticidal Nets (LLIN)
Distribution of long lasting insecticidal nets to all community members in the study arm allowing for at least one net per 2 persons
Device: Long Lasting Insecticidal Nets (LLIN)
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.
Other Names:
  • Insecticide Treated Nets (ITN)
  • Permanet2.0
Experimental: LLIN Plus Indoor Residual Spraying
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.
Device: Long Lasting Insecticidal Nets (LLIN)
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.
Other Names:
  • Insecticide Treated Nets (ITN)
  • Permanet2.0
Other: Indoor residual insecticide spraying (IRS)
Application of insecticide to interior walls of domiciliary structures to kill malaria vector mosquitoes which rest on walls after taking human blood meal
Other Names:
  • IRS
  • Pesticide
  • Bendiocarb
  • Deltamethrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Malaria Incidence
Time Frame: 3 years
Infection with malarial parasites determined by rapid diagnostic tests/microscopy in cohort members who report or have fever (>37.5C)
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of P.falciparum Infection
Time Frame: 3 years
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
3 years
Entomological Innoculation rate
Time Frame: Average for months Sept, Oct, Nov for years 2011, 2012, 2013
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.
Average for months Sept, Oct, Nov for years 2011, 2012, 2013
Frequency of insecticide resistance associated genotypes (kdr) in anopheles arabiensis
Time Frame: Yearly average 2011, 2012, 2013, 2014
Molecular analysis of mosquito specimens caught in subset of clusters by pyrethrum spray collection.
Yearly average 2011, 2012, 2013, 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

World Health Organization
Liverpool School of Tropical Medicine
Federal Ministry of Health, Sudan

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

October 22, 2012

First Submitted That Met QC Criteria

October 22, 2012

First Posted (Estimate)

October 24, 2012

Study Record Updates

Last Update Posted (Estimate)

October 26, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WHO_IR_SUDAN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malaria, Falciparum

Clinical Trials on Long Lasting Insecticidal Nets (LLIN)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe