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

March 15, 2012 updated by: Mbarara University of Science and Technology
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

6456

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • Sapone, Burkina Faso
        • Sapone Site
  • Ghana
      • Kassana, Ghana
        • Kassena Nankana Site
  • Uganda
      • Iganga, Uganda
        • Iganga Site
      • Mbarara, Uganda
        • Mbarara Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACT, antibiotic, paracetamol
CHWs will test children with acute febrile illness for malaria using RDTs, and for pneumonia by counting their respiratory rate with RRTs. Treatment will then be provided on the basis of the test results, in line with national guidelines. Children with a positive RDT will receive artemether-lumefantrine in Burkina Faso and Uganda, and artesunate-amodiaquine in Ghana. Children with a cough and a high respiratory rate will receive amoxicillin in Ghana and Uganda, and cotrimoxazole in Burkina Faso. Additionally, paracetamol (PCT) will be provided to all children with an axillary temperature > 38.5°C.
Drug: Artemether-lumefantrine combination
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
Drug: amoxycillin
amoxycillin 250mg tab 4-12 months: 1/2x2; 13-35 months: 1x2; 36-59 months: 11/2x2
Drug: paracetamol
paracetamol 500mg tablet <36months: 1/4x4 for 2 days; 36-59months: 1/2x4 for 2 days
Device: malaria rapid diagnostic test, respiratory rate timer
malaria dipstick, and breath timer
Drug: Artemether-lumefantrine combination
20/120mg tablet arthermether-lumefantrine 4-35months: 1x2; 36-59months: 2x2
No Intervention: Presumptive fever management
Presumptive treatment of malaria with ACTs. No antibiotic treatment available
Drug: Artemether-lumefantrine combination
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
Drug: Artemether-lumefantrine combination
20/120mg tablet arthermether-lumefantrine 4-35months: 1x2; 36-59months: 2x2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recovery rate from fever at Day 3
Time Frame: Day 3
Day 3

Secondary Outcome Measures

Outcome Measure
Time Frame
use of antimalarial and antibiotic drugs by community health workers
Time Frame: After patient enrollment
After patient enrollment
Recovery rate from fever at Day 7
Time Frame: Day 7
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mbarara University of Science and Technology

Collaborators

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

Investigators

  • Study Director: Francis Bajunirwe, MBChB PhD, Mbarara University of Science and Technology
  • Study Director: George Pariyo, MB ChB, PhD, Makerere University
  • Principal Investigator: James Tibenderana, MB ChB, PhD, Malaria Consortium
  • Principal Investigator: Alfred Tiono, PhD, National Malaria Research and Training Center, Burkina Faso
  • Principal Investigator: Thomas Anyorigiya, MSc, Navrongo Health Research Centre, Ghana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 21, 2008

First Submitted That Met QC Criteria

July 22, 2008

First Posted (Estimate)

July 23, 2008

Study Record Updates

Last Update Posted (Estimate)

March 16, 2012

Last Update Submitted That Met QC Criteria

March 15, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A60487

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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