Welcome
Support Centre
21 August 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Procalcitonin guided antibiotic use in Acute Respiratory Tract Infections (ARTIs) in primary care
ISRCTN ISRCTN73182671
DOI 10.1186/ISRCTN73182671
ClinicalTrials.gov identifier NCT00099840
EudraCT number
Public title Procalcitonin guided antibiotic use in Acute Respiratory Tract Infections (ARTIs) in primary care
Scientific title
Acronym PARTI-Study
Serial number at source EKBB 254/04
Study hypothesis 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.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Switzerland
Disease/condition/study domain Acute respiratory tract infections
Participants - inclusion criteria 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.
Participants - exclusion criteria Are excluded patients without informed consent, not fluent in German, with antibiotic pretreatment in previous 28 days or severe immune-suppression.
Anticipated start date 01/12/2004
Anticipated end date 31/03/2006
Status of trial Completed
Patient information material
Target number of participants 400
Interventions 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").
Primary outcome measure(s) Days with restrictions from ARTI
Secondary outcome measure(s) 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
Sources of funding 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)
Trial website
Publications http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids= 16107222
Contact name Prof  Beat  Muller
  Address University Hospital
Petersgraben 4
  City/town Basel
  Zip/Postcode 4031
  Country Switzerland
  Tel +41 (0)61 265 2525
  Fax +41 (0)61 265 5100
  Email Happy.Mueller@unibas.ch
Sponsor University Hospital Basel (Switzerland)
  Address Petersgraben 4
  City/town Basel
  Zip/Postcode 4031
  Country Switzerland
  Tel +41 (0)61 265 2525
  Fax +41 (0)61 265 5100
  Email Happy.Mueller@unibas.ch
Date applied 18/01/2005
Last edited 10/07/2006
Date ISRCTN assigned 15/02/2005
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.