Suspended

Cluster Randomised Trial to Compare Effectiveness of the Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) to LLINs Alone for Malaria Prevention in Muleba District, Kagera Region, Tanzania

What is being tested

Indoor residual spraying with bendiocarb

+ LLIN by universal coverage campaign

Other

Who is being recruted

Vector Borne Diseases+3

+ Mosquito-Borne Diseases

+ Infections

From 6 Months to 14 Years

+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 4

Interventional

Study Start: January 2011

See protocol details

Summary

Principal SponsorLondon School of Hygiene and Tropical Medicine

Study ContactMark Rowland, PHDMore contacts

Last updated: October 3, 2012

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2011

Actual date on which the first participant was enrolled.

The study is a cluster randomised trial to compare the effectiveness of indoor residual spraying (IRS) combined with the use of long lasting insecticidal nets (LLINs) with the effectiveness of LLINs alone for preventing malaria infection and morbidity. The primary outcome measure is prevalence of parasitaemia and anaemia in children aged 0.5-10 years, measured in cross sectional surveys. Secondary outcomes include relative population density for each mosquito vector species, malaria transmission as measured by entomological inoculation rates (EIR) by mosquito vector species, monitoring of resistance markers including kdr, and user acceptability of LLINs compared with IRS. Findings from this study are expected to inform decision making so that resource utilization can be optimised.

NCT01697852

Principal SponsorLondon School of Hygiene and Tropical Medicine

Study ContactMark Rowland, PHDMore contacts

Last updated: October 3, 2012

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

22300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 Months to 14 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Vector Borne DiseasesMosquito-Borne DiseasesInfectionsParasitic DiseasesProtozoan InfectionsMalaria

Criteria

1 inclusion criteria required to participate

resident in selected cluster (village)

1 exclusion criteria prevent from participating

Not resident in selected cluster (village)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

LLIN by universal coverage campaign 2 rounds of indoor residual spraying with bendiocarb insecticide

Group II

Active Comparator

LLIN by universal coverage campaign

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

PAMVERC office

Muleba, TanzaniaOpen PAMVERC office in Google Maps

SuspendedOne Study Center