Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs
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ClinicalTrials.gov Identifier: NCT00720811 |
Recruitment Status
:
Completed
First Posted
: July 23, 2008
Last Update Posted
: March 16, 2012
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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
Information provided by (Responsible Party):
Mbarara University of Science and Technology
Tracking Information | ||||||||||||||||
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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 |
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 |
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Original Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||
Actual Enrollment ICMJE |
6456 | |||||||||||||||
Original Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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Investigators ICMJE |
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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 |