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Sponsors and Collaborators: |
Centro per le Malattie Tropicali Institute of Tropical Medicine, Belgium |
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Information provided by: | Centro per le Malattie Tropicali |
ClinicalTrials.gov Identifier: | NCT00317590 |
There is increasing evidence from African countries, including Burkina Faso, that at least in some settings/seasons the proportion of fevers attributable to malaria is low or very low: this means that the current strategy of treating all fever cases as malaria is only to the advantage of very few. Rapid, antigenic tests might be of help, particularly in peripheral health centres such as the "Centres de Santé et Promotion Sociale" (CSPS) that lack any laboratory facilities. Nevertheless two major problems could arise:
The main purpose of this study is to assess if the short term outcome of febrile patients treated after testing with the Rapid Diagnostic Test Paracheck® is at least equivalent (not inferior) to that of controls (presumptively treated without any test) in terms of clearance of fever and other major symptoms and signs.
To do so, febrile patients will be randomly assigned to be submitted to the test before clinical decision, or to be managed the usual way with no test. A follow up will be carried out at Day 4th in order to determine the proportion of patients in both groups with persistence of fever and other main clinical symptoms.
Condition | Intervention | Phase |
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Malaria |
Device: Rapid Diagnostic Test for Malaria (Paracheck®) |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation de l'utilité et du coût-efficacité du Test Rapide Paracheck® Pour la Prise en Charge Des Cas de Paludisme Dans Les régions Des Hauts Bassins et Des Cascades, au Burkina Faso |
Estimated Enrollment: | 4000 |
Study Start Date: | April 2006 |
Study Completion Date: | October 2006 |
Ages Eligible for Study: | 6 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pregnancy NOT an exclusion criterion
Burkina Faso, Hauts Bassins | |
Districts Médicaux de Banfora et de Bobo 15 | |
Bobo Dioulasso, Hauts Bassins, Burkina Faso |
Principal Investigator: | Zeno Bisoffi, MD, DTM&H | Centro per le Malattie Tropicali, Ospedale S. Cuore, Negrar (Verona), Italy |
Study ID Numbers: | AnKaHeresoRDT |
Study First Received: | April 23, 2006 |
Last Updated: | October 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00317590 |
Health Authority: | Burkina Faso: Ministry of Health |
Diagnosis Rapid Diagnostic Test Management Attributable Fraction Threshold |
Protozoan Infections Parasitic Diseases Malaria |
Coccidiosis |