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ISRCTN
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ISRCTN73182671
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ClinicalTrials.gov identifier
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NCT00099840
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Public title
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Procalcitonin guided antibiotic use in Acute Respiratory Tract Infections (ARTIs) in primary care
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Scientific title
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Acronym
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PARTI-Study
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Serial number at source
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EKBB 254/04
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Study hypothesis
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Acute respiratory tract infections (ARTI) are among the most frequent reasons for seeking medical attention in primary care. Although from predominantly viral origin, ARTIs are the most important condition for the prescription of antibiotics (AB), mainly due to the difficulty in primary care to differentiate between viral and bacterial etiology. Unnecessary AB use increases drug expenditures, side effects and AB resistance. A novel approach is to guide AB use by procalcitonin (ProCT), since serum levels are elevated in bacterial infections but remain lower in viral infections and inflammatory diseases. We aim to compare a strategy based on evidence-based guidelines with ProCT guided AB therapy in ARTIs with respect to outcome (days with restriction) and AB use.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Switzerland
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Disease/condition/study domain
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Acute respiratory tract infections
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Participants - inclusion criteria
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18 years or older, with ARTI of >1 and <28 days duration and in need of antibiotics based on the clinical judgment of the primary care physician.
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Participants - exclusion criteria
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Are excluded patients without informed consent, not fluent in German, with antibiotic pretreatment in previous 28 days or severe immune-suppression.
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Anticipated start date
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01/12/2004
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Anticipated end date
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31/03/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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400
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Interventions
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All participating physicians will receive evidence-based guidelines for the management of patients with ARTIs. Patients with ARTI and in need of antibiotics by physicians' clinical judgment and with informed consent will be randomized to procalcitonin (ProCT) guided antibiotic prescription ("ProCT group") versus guidelines guided antibiotic prescription ("control group").
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Primary outcome measure(s)
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Days with restrictions from ARTI
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Secondary outcome measure(s)
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Rate of AB prescriptions; days with AB use; symptoms from ARTI; relapse rate from ARTI within 28 days; days with side effects from ABs and off work; cost-effectiveness
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Sources of funding
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University Hospital Basel - Clinic of Endocrinology, Basel Institute of Clinical Epidemiology (BICE), Dept. of Internal Medicine, Dept. of Central Laboratories (infrastructure)
BRAHMS AG, Hennigsdorf, Germany (assay material)
Swiss National Science Foundation (grant approval pending)
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Trial website
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Publications
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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids= 16107222
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Contact name
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Prof
Beat
Muller
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Address
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University Hospital
Petersgraben 4
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City/town
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Basel
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Zip/Postcode
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4031
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Country
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Switzerland
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Tel
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+41 (0)61 265 2525
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Fax
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+41 (0)61 265 5100
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Email
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Happy.Mueller@unibas.ch
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Sponsor
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University Hospital Basel (Switzerland)
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Address
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Petersgraben 4
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City/town
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Basel
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Zip/Postcode
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4031
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Country
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Switzerland
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Tel
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+41 (0)61 265 2525
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Fax
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+41 (0)61 265 5100
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Email
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Happy.Mueller@unibas.ch
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Date applied
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18/01/2005
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Last edited
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10/07/2006
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Date ISRCTN assigned
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15/02/2005
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