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

Hdl Handle:
http://hdl.handle.net/10144/114154
Title:
Rapid malaria diagnostic tests vs. clinical management of malaria in rural Burkina Faso: safety and effect on clinical decisions. A randomized trial
Authors:
Bisoffi, Zeno; Sirima, Bienvenu Sodiomon; Angheben, Andrea; Lodesani, Claudia; Gobbi, Federico; Tinto, Halidou; Van den Ende, Jef
Journal:
Tropical Medicine & International Health : TM & IH
Abstract:
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.
Affiliation:
Centre for Tropical Diseases, Sacro Cuore Hospital, Negrar (Verona), Italy; Centre National de Recherche et de Formation sur le Paludisme, Ministry of Health, Ouagadougou, Burkina Faso; Medecins sans Frontieres, Democratic Republic of Congo; Centre Muraz, Bobo Dioulasso, Burkina Faso; Projet AnKaHeresso, Bobo Dioulasso, Burkina Faso; Department of Clinical Sciences, Prince Leopold Institute of Tropical Medicine, Antwerp, Belgium
Issue Date:
15-Feb-2009
URI:
http://hdl.handle.net/10144/114154
DOI:
10.1111/j.1365-3156.2009.02246.x
PubMed ID:
19222821
Additional Links:
http://www.ncbi.nlm.nih.gov/pubmed
Type:
Article
Language:
en
ISSN:
1365-3156
Appears in Collections:
Malaria

Full metadata record

DC FieldValue Language
dc.contributor.authorBisoffi, Zenoen
dc.contributor.authorSirima, Bienvenu Sodiomonen
dc.contributor.authorAngheben, Andreaen
dc.contributor.authorLodesani, Claudiaen
dc.contributor.authorGobbi, Federicoen
dc.contributor.authorTinto, Halidouen
dc.contributor.authorVan den Ende, Jefen
dc.date.accessioned2010-10-29T15:48:40Z-
dc.date.available2010-10-29T15:48:40Z-
dc.date.issued2009-02-15-
dc.identifier.citationTrop. Med. Int. Health 2009;14(5):491-8en
dc.identifier.issn1365-3156-
dc.identifier.pmid19222821-
dc.identifier.doi10.1111/j.1365-3156.2009.02246.x-
dc.identifier.urihttp://hdl.handle.net/10144/114154-
dc.description.abstractOBJECTIVES: 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.isoenen
dc.relation.urlhttp://www.ncbi.nlm.nih.gov/pubmeden
dc.rightsArchived on this site with the kind permission of Wiley-Blackwell, [url]http://www.blackwell-synergy.com/loi/tmi[/url]en
dc.subject.meshAdolescenten
dc.subject.meshAdulten
dc.subject.meshAntimalarialsen
dc.subject.meshBurkina Fasoen
dc.subject.meshChilden
dc.subject.meshChild, Preschoolen
dc.subject.meshFemaleen
dc.subject.meshFeveren
dc.subject.meshHealth Personnelen
dc.subject.meshHumansen
dc.subject.meshInfanten
dc.subject.meshMalariaen
dc.subject.meshMaleen
dc.subject.meshMiddle Ageden
dc.subject.meshOutcome Assessment (Health Care)en
dc.subject.meshReagent Kits, Diagnosticen
dc.subject.meshRural Healthen
dc.subject.meshSeasonsen
dc.subject.meshYoung Adulten
dc.titleRapid malaria diagnostic tests vs. clinical management of malaria in rural Burkina Faso: safety and effect on clinical decisions. A randomized trialen
dc.typeArticleen
dc.contributor.departmentCentre for Tropical Diseases, Sacro Cuore Hospital, Negrar (Verona), Italy; Centre National de Recherche et de Formation sur le Paludisme, Ministry of Health, Ouagadougou, Burkina Faso; Medecins sans Frontieres, Democratic Republic of Congo; Centre Muraz, Bobo Dioulasso, Burkina Faso; Projet AnKaHeresso, Bobo Dioulasso, Burkina Faso; Department of Clinical Sciences, Prince Leopold Institute of Tropical Medicine, Antwerp, Belgiumen
dc.identifier.journalTropical Medicine & International Health : TM & IHen

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