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Completed

NCT Number: NCT00720811

Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs

This study is to assess the value of incorporating a malaria RDT based strategy in HMM. The primary activity of the study wil be a two armed cluster randomised trial in two study sites in Uganda, one in Ghana and one in Burkina Faso. One of the Uganda sites is highly endemic and the other meso-endemic for malaria. In one arm the children will be treated presumptively for malaria with ACT (control arm) and the other arm the children will receive ACT only when they have a positive RDT result (implementation arm). The children in the implementation arm will also receive antibiotics if they have a raised respiratory rate. The primary outcome will be the recovery rate in the intervention arm compared to that of the control arm on Day 3. In addition, an acceptability assessment of RDTs in the community will be undertaken both before and after the intervention trial and a cost-effectiveness analysis of the RDT strategy will also be completed. For a sub-sample, microscopy slides will also be taken on Day 0 to demonstrate comparable levels of endemicity in control and intervention groups. These activities will be carried out over a two year period.

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Key information

Conditions

Malaria Behavior Disease Fasting Feeding Behavior Infections Lung Diseases Mosquito-Borne Diseases Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Protozoan Infections Respiratory Tract Diseases Respiratory Tract Infections Vector Borne Diseases

Age range

4 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sapone Site, Saponé, Burkina Faso

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About this study

This is an open, cluster randomised multicentre two arm trial in the three countries of Burkina Faso, Ghana and Uganda. Clusters are villages (catchment populations) of individual community health workers (CHWs). Within the study areas, clusters that are more than 5 km from a designate health facility where CHWs referred cases for special care will be excluded. A cluster randomized design was chosen over an individually randomized design to reduce contamination, facilitate supervision, reduce costs, and to ensure that the CHWs maintained the correct treatments based on the tests in the Intervention arm and the presumptive treatment in the Control arm.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children between 4-59 months of age with a history of fever in the last 24 hours presenting to the community medicine distributor

Exclusion criteria

  • Children classified as having severe illness according to IMCI guidelines. Children suffering from Chronic disease(s), those with reported anti malarial or antibiotic treatment (intervention) arm in previous two weeks and those whose caregivers refuse to consent to participate

Treatment and study plan

Artemether-lumefantrine combination

Drug

20/120mg Artemether-lumefantrine 4-35 months: 1 tablet twice daily for 3 days; 36-59 months: 2 tablets twice daily for 3 days

Other names: Coartem

Amoxycillin

Drug

amoxycillin 250mg tab 4-12 months: 1/2x2; 13-35 months: 1x2; 36-59 months: 11/2x2

Paracetamol

Drug

paracetamol 500mg tablet <36months: 1/4x4 for 2 days; 36-59months: 1/2x4 for 2 days

malaria rapid diagnostic test, respiratory rate timer

Device

malaria dipstick, and breath timer

Primary outcomes

  1. Recovery rate from fever at Day 3

    Time frame: Day 3

Secondary outcomes

  1. use of antimalarial and antibiotic drugs by community health workers

    Time frame: After patient enrollment

  2. Recovery rate from fever at Day 7

    Time frame: Day 7

Sponsors and collaborators

Lead sponsor

Mbarara University of Science and Technology

Other

Collaborators

  • Makerere University
  • Ministry of Health, Uganda
  • National Malaria Research and Training Centre, Burkina Faso
  • Navrongo Health Research Centre, Ghana

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 23, 2008
Registry last updated
Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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