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

Tracking Information
First Submitted Date ICMJE	July 21, 2008
First Posted Date ICMJE	July 23, 2008
Last Update Posted Date	March 16, 2012
Study Start Date ICMJE	October 2009
Actual Primary Completion Date	January 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 22, 2008)	Recovery rate from fever at Day 3 [ Time Frame: Day 3 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00720811 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 12, 2011)	use of antimalarial and antibiotic drugs by community health workers [ Time Frame: After patient enrollment ]; Recovery rate from fever at Day 7 [ Time Frame: Day 7 ]
Original Secondary Outcome Measures ICMJE; (submitted: July 22, 2008)	Description of feasibility of using RDTs by the Community Medicine Distributors [ Time Frame: After patient enrollment ]; Recovery rate from fever at Day 7 [ Time Frame: Day 7 ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs
Official Title ICMJE	Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs
Brief Summary	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.
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 ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Malaria; Pneumonia
Intervention ICMJE	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
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 12, 2011)	6456
Original Actual Enrollment ICMJE; (submitted: July 22, 2008)	1050
Actual Study Completion Date	January 2012
Actual Primary Completion Date	January 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	4 Months to 59 Months (Child)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Burkina Faso, Ghana, Uganda
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00720811
Other Study ID Numbers ICMJE	A60487
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Mbarara University of Science and Technology
Study Sponsor ICMJE	Mbarara University of Science and Technology
Collaborators ICMJE	Makerere University; Ministry of Health, Uganda; Navrongo Health Research Centre, Ghana; National Malaria Research and Training Centre, Burkina Faso
Investigators ICMJE	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
PRS Account	Mbarara University of Science and Technology
Verification Date	March 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP