Impact of Insecticide Resistance on Vector Control

Malaria, Falciparum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01713517
• Other study ID #: WHO_IR_SUDAN
• Status: Recruiting
• Phase: Phase 4
• First received: October 22, 2012
• Last updated: October 25, 2012
• Start date: April 2011
• Est. completion date: October 2014

Study information

• Verified date: October 2012
• Source: London School of Hygiene and Tropical Medicine
• Contact: Hmooda T Kafy, MSc (London)
• Phone: +249 123 399 994
• Email: hmoodak[@]yahoo.com
• Is FDA regulated: No
• Health authority: Sudan: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28000
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 10 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

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

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.

Locations

Country	Name	City	State
Sudan	Malaria Control Programme	Gedarif	Gedarif State
Sudan	Malaria Control Programme	Kassala	Kassala State
Sudan	Malaria Control Programme	Wad Medani	Gezira State

Sponsors (4)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Federal Ministry of Health, Sudan, Liverpool School of Tropical Medicine, World Health Organization

Country where clinical trial is conducted

Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malaria Incidence	Infection with malarial parasites determined by rapid diagnostic tests/microscopy in cohort members who report or have fever (>37.5C)	3 years	No
Secondary	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	3 years	No
Secondary	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.	Average for months Sept, Oct, Nov for years 2011, 2012, 2013	No
Secondary	Frequency of insecticide resistance associated genotypes (kdr) in anopheles arabiensis	Molecular analysis of mosquito specimens caught in subset of clusters by pyrethrum spray collection.	Yearly average 2011, 2012, 2013, 2014	No