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Rapid malaria diagnostic tests vs. clinical management of malaria in rural Burkina Faso: safety and effect on clinical decisions; a randomized trial

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Show simple item record Bisoffi, Z. Sirima, B. S. Angheben, A. Lodesani, C. Gobbi, F. Tinto, H. Van den Ende, J. 2009-05-16T07:23:42Z 2009-05-16T07:23:42Z 2009
dc.identifier.issn 1360-2276
dc.identifier.other ITG-CLA
dc.identifier.other CLINIC
dc.identifier.other U-TROPIC
dc.identifier.other JIF
dc.identifier.other DOI
dc.identifier.other UPD13
dc.identifier.other FTB
dc.identifier.other ABSTRACT
dc.description.abstract Summary Objectives To assess if the clinical outcome of patients treated after performing a Rapid Diagnostic Test for malaria (RDT) is at least equivalent to that of controls (treated presumptively without test) and to determine the impact of the introduction of a malaria RDT on clinical decisions. Methods Randomized, multi-centre, open clinical trial in two arms in 2006 at the end of the dry and of the rainy season in 10 peripheral health centres in Burkina Faso: one arm with use of RDT before treatment decision, one arm managed clinically. Primary endpoint: persistence of fever at day 4. Secondary endpoints: frequency of malaria treatment and of antibiotic treatment. Results A total of 852 febrile patients were recruited in the dry season and 1317 febrile patients in the rainy season, and randomized either to be submitted to RDT (P_RTD) or to be managed presumptively (P_CLIN). In both seasons, no significant difference was found between the two randomized groups in the frequency of antimalarial treatment, nor of antibiotic prescription. In the dry season, 80.8% and 79.8% of patients with a negative RDT were nevertheless diagnosed and treated for malaria, and so were 85.0% and 82.6% negative patients in the rainy season. In the rainy season only, both diagnosis and treatment of other conditions were significantly less frequent in RDT positive vs. negative patients (48.3%vs. 61.4% and 46.2%vs. 59.9%, P = 0.00 and 0.00, respectively). Conclusion Our study was inconclusive on RDT safety (clinical outcome in the two randomized groups), because of an exceedingly and unexpectedly low compliance with the negative test result. Further research is needed on best strategies to promote adherence and on the safety of a test based strategy compared with the current, presumptive treatment strategy. en
dc.language English en
dc.publisher Blackwell Publishing en
dc.subject Protozoal diseases en
dc.subject Malaria en
dc.subject Drug therapy en
dc.subject Presumptive treatment en
dc.subject Clinical diagnosis en
dc.subject Rapid diagnostic tests en
dc.subject Health personnel en
dc.subject Decision making en
dc.subject Compliance en
dc.subject Guideline adherence en
dc.subject Burkina Faso en
dc.subject Africa, West en
dc.title Rapid malaria diagnostic tests vs. clinical management of malaria in rural Burkina Faso: safety and effect on clinical decisions; a randomized trial en
dc.type Article en
dc.citation.issue 5 en
dc.citation.jtitle Tropical Medicine and International Health en
dc.citation.volume 14 en
dc.citation.pages 491-498 en
dc.citation.jabbreviation Trop Med Int Health en

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