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

This study has been completed.
Sponsor:
Collaborators:
Makerere University
Ministry of Health, Uganda
Navrongo Health Research Centre, Ghana
National Malaria Research and Training Centre, Burkina Faso
Information provided by (Responsible Party):
Mbarara University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00720811
First received: July 21, 2008
Last updated: March 15, 2012
Last verified: March 2012

July 21, 2008
March 15, 2012
October 2009
January 2012   (final data collection date for primary outcome measure)
Recovery rate from fever at Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00720811 on ClinicalTrials.gov Archive Site
  • use of antimalarial and antibiotic drugs by community health workers [ Time Frame: After patient enrollment ] [ Designated as safety issue: No ]
  • Recovery rate from fever at Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Description of feasibility of using RDTs by the Community Medicine Distributors [ Time Frame: After patient enrollment ] [ Designated as safety issue: No ]
  • Recovery rate from fever at Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Malaria
  • Pneumonia
  • 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 Name: 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
  • 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.
    Interventions:
    • Drug: Artemether-lumefantrine combination
    • Drug: amoxycillin
    • Drug: paracetamol
    • Device: malaria rapid diagnostic test, respiratory rate timer
  • No Intervention: Presumptive fever management
    Presumptive treatment of malaria with ACTs. No antibiotic treatment available
    Intervention: Drug: Artemether-lumefantrine combination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6456
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
4 Months to 59 Months
No
Contact information is only displayed when the study is recruiting subjects
Burkina Faso,   Ghana,   Uganda
 
NCT00720811
A60487
Yes
Mbarara University of Science and Technology
Mbarara University of Science and Technology
  • Makerere University
  • Ministry of Health, Uganda
  • Navrongo Health Research Centre, Ghana
  • National Malaria Research and Training Centre, Burkina Faso
Study Director: Francis Bajunirwe, MBChB PhD Mbarara University of Science and Technology
Study Director: George Pariyo, MB ChB, PhD Makerere University School of Public Health
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
Mbarara University of Science and Technology
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP