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Impact of Insecticide Resistance on Vector Control

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by London School of Hygiene and Tropical Medicine
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
ClinicalTrials.gov Identifier:
NCT01713517
First received: October 22, 2012
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Malaria, Falciparum
Other: Indoor residual insecticide spraying (IRS)
Device: Long Lasting Insecticidal Nets (LLIN)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Insecticide Resistance in Anopheles Arabiensis on the Effectiveness of Malaria Vector Control in Sudan

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Malaria Incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Molecular analysis of mosquito specimens caught in subset of clusters by pyrethrum spray collection.


Estimated Enrollment: 28000
Study Start Date: April 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.

  Eligibility

Ages Eligible for Study:   6 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713517

Contacts
Contact: Hmooda T Kafy, MSc (London) +249 123 399 994 hmoodak@yahoo.com
Contact: Bashir A Ismail, MSc (USM) +249 912938842 bashiradam69@yahoo.co.uk

Locations
Sudan
Malaria Control Programme Recruiting
Gedarif, Gedarif State, Sudan
Contact: Anwar Banaga, MSc    +249 122645846    anwrbanaga@yahoo.com   
Malaria Control Programme Recruiting
Wad Medani, Gezira State, Sudan
Contact: Sakhr B Elshiekh, MSc    +249 117587549    sakhr_14@yahoo.com   
Malaria Control Programme Recruiting
Kassala, Kassala State, Sudan
Contact: Shaaaldeen H Hussein, MSc    +249 117587536    shaaaldeen64@gmail.com   
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Federal Ministry of Health, Sudan
World Health Organization
Liverpool School of Tropical Medicine
Investigators
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
  More Information

No publications provided

Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01713517     History of Changes
Other Study ID Numbers: WHO_IR_SUDAN
Study First Received: October 22, 2012
Last Updated: October 25, 2012
Health Authority: Sudan: Ministry of Health

Keywords provided by London School of Hygiene and Tropical Medicine:
Mosquito Control
Insecticide Resistance

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on August 18, 2014