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Impact of Insecticide Resistance on Vector Control

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ClinicalTrials.gov Identifier: NCT01713517
Recruitment Status : Unknown
Verified October 2012 by London School of Hygiene and Tropical Medicine.
Recruitment status was:  Recruiting
First Posted : October 24, 2012
Last Update Posted : October 26, 2012
Sponsor:
Collaborators:
Federal Ministry of Health, Sudan
World Health Organization
Liverpool School of Tropical Medicine
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Tracking Information
First Submitted Date  ICMJE October 22, 2012
First Posted Date  ICMJE October 24, 2012
Last Update Posted Date October 26, 2012
Study Start Date  ICMJE April 2011
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01713517 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2012)
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
  • 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
  • Entomological Innoculation rate [ Time Frame: Annual 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.
  • Frequency of insecticide resistance associated genotypes (kdr) in anopheles arabiensis [ Time Frame: Annually 2011, 2012, 2013, 2014 ]
    Molecular analysis of mosquito specimens caught in subset of clusters by pyrethrum spray collection.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Insecticide Resistance on Vector Control
Official Title  ICMJE Impact of Insecticide Resistance in Anopheles Arabiensis on the Effectiveness of Malaria Vector Control in Sudan
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Malaria, Falciparum
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Device: Long Lasting Insecticidal Nets (LLIN)
  • 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.
    Interventions:
    • Other: Indoor residual insecticide spraying (IRS)
    • Device: Long Lasting Insecticidal Nets (LLIN)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 22, 2012)
28000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2014
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sudan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01713517
Other Study ID Numbers  ICMJE WHO_IR_SUDAN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party London School of Hygiene and Tropical Medicine
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE
  • Federal Ministry of Health, Sudan
  • World Health Organization
  • Liverpool School of Tropical Medicine
Investigators  ICMJE
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
PRS Account London School of Hygiene and Tropical Medicine
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP