Effectiveness and Cost-Effectiveness of a Rapid Diagnostic Test for Malaria
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|ClinicalTrials.gov Identifier: NCT00317590|
Recruitment Status : Completed
First Posted : April 25, 2006
Last Update Posted : October 31, 2007
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:
- False negatives: as only the negative result would change the decision to treat, versus the current "presumptive" strategy, false negatives would not be treated for malaria.
- False positives: they would be exposed to the risk to be left without treatment for the true cause of their fever instead.
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 or disease||Intervention/treatment||Phase|
|Malaria||Device: Rapid Diagnostic Test for Malaria (Paracheck®)||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2006|
|Actual Study Completion Date :||October 2006|
- Clearance of fever
- Clearance of major clinical symptoms/signs
- Attributable fraction (AF) of fever episodes to malaria
- Performances of Paracheck® (sensitivity, specificity and predictive values) on malaria disease
- Cost-effectiveness of Paracheck® vs. presumptive (clinical) management of fever
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317590
|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|