Clinical trial NCT01713517: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Malaria, Falciparum
Keywords: Mosquito Control
Insecticide Resistance
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Federal Ministry of Health, Sudan
name: World Health Organization
name: Liverpool School of Tropical Medicine
First posted: 2012-10-24
Enrollment: 28000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Malaria Incidence
timeFrame: 3 years
Secondary outcomes:
measure: Prevalence of P.falciparum Infection
timeFrame: 3 years
measure: Entomological Innoculation rate
timeFrame: Average for months Sept, Oct, Nov for years 2011, 2012, 2013
measure: Frequency of insecticide resistance associated genotypes (kdr) in anopheles arabiensis
timeFrame: Yearly average 2011, 2012, 2013, 2014
Other outcomes:
Locations:
city: Gedarif
country: Sudan
facility: Malaria Control Programme
state: Gedarif State
city: Wad Medani
country: Sudan
facility: Malaria Control Programme
state: Gezira State
city: Kassala
country: Sudan
facility: Malaria Control Programme
state: Kassala State
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Immo Kleinschmidt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liverpool School of Tropical Medicine
name: Martin J Donnelly, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal Ministry of Health, Sudan
name: Khalid A Elmardi, MD
role: STUDY_DIRECTOR
affiliation: Federal Ministry of Health, Sudan
name: Hmooda T Kafy, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal Ministry of Health, Sudan
name: Bashir A Ismail, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal Ministry of Health, Sudan
name: Mohamed Ahmed A Mohamed, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.