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Impact of Insecticide Resistance on Vector Control

NCT ID: NCT01713517

Last Updated: 2012-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

28000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Malaria, Falciparum

Keywords

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Mosquito Control Insecticide Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Long Lasting Insecticidal Nets (LLIN)

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

Indoor residual insecticide spraying (IRS)

Intervention Type OTHER

Application of insecticide to interior walls of domiciliary structures to kill malaria vector mosquitoes which rest on walls after taking human blood meal

Long Lasting Insecticidal Nets (LLIN)

Intervention Type DEVICE

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.

Interventions

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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

Intervention Type OTHER

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.

Intervention Type DEVICE

Other Intervention Names

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IRS Pesticide Bendiocarb Deltamethrin Insecticide Treated Nets (ITN) Permanet2.0

Eligibility Criteria

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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)
Minimum Eligible Age

6 Months

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal Ministry of Health, Sudan

OTHER_GOV

Sponsor Role collaborator

World Health Organization

OTHER

Sponsor Role collaborator

Liverpool School of Tropical Medicine

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Immo Kleinschmidt, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Martin J Donnelly, PhD

Role: PRINCIPAL_INVESTIGATOR

Liverpool School of Tropical Medicine

Khalid A Elmardi, MD

Role: STUDY_DIRECTOR

Federal Ministry of Health, Sudan

Hmooda T Kafy, MSc

Role: PRINCIPAL_INVESTIGATOR

Federal Ministry of Health, Sudan

Bashir A Ismail, MSc

Role: PRINCIPAL_INVESTIGATOR

Federal Ministry of Health, Sudan

Mohamed Ahmed A Mohamed, MSc

Role: PRINCIPAL_INVESTIGATOR

Federal Ministry of Health, Sudan

Locations

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Malaria Control Programme

Wad Medani, Al Jazīrah, Sudan

Site Status RECRUITING

Malaria Control Programme

Gedarif, Gedarif State, Sudan

Site Status RECRUITING

Malaria Control Programme

Kassala, Kassala, Sudan

Site Status RECRUITING

Countries

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Sudan

Central Contacts

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Hmooda T Kafy, MSc (London)

Role: CONTACT

Phone: +249 123 399 994

Email: [email protected]

Bashir A Ismail, MSc (USM)

Role: CONTACT

Phone: +249 912938842

Email: [email protected]

Facility Contacts

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Sakhr B Elshiekh, MSc

Role: primary

Anwar Banaga, MSc

Role: primary

Shaaaldeen H Hussein, MSc

Role: primary

References

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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.

Reference Type DERIVED
PMID: 29229808 (View on PubMed)

Other Identifiers

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WHO_IR_SUDAN

Identifier Type: -

Identifier Source: org_study_id