Contact information
Type
Scientific
Primary contact
Prof Beat Muller
ORCID ID
Contact details
University Hospital
Petersgraben 4
Basel
4031
Switzerland
+41 (0)61 265 2525
Happy.Mueller@unibas.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00099840
Protocol/serial number
EKBB 254/04
Study information
Scientific title
Procalcitonin-guided antibiotic use in Acute Respiratory Tract Infections (ARTIs) in primary care
Acronym
PARTI-Study
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Acute respiratory tract infections
Intervention
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").
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Days with restrictions from ARTI
Secondary outcome measures
1. Rate of AB prescriptions; days with AB use
2. Symptoms from ARTI
3. Relapse rate from ARTI within 28 days
4. Days with side effects from ABs and off work
5. Cost-effectiveness
Overall trial start date
01/12/2004
Overall trial end date
31/03/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Patients without informed consent
2. Not fluent in German
3. Antibiotic pretreatment in previous 28 days
4. Severe immune-suppression
Recruitment start date
01/12/2004
Recruitment end date
31/03/2006
Locations
Countries of recruitment
Switzerland
Trial participating centre
University Hospital Basel
Basel
4031
Switzerland
Sponsor information
Organisation
University Hospital Basel (Switzerland)
Sponsor details
Petersgraben 4
Basel
4031
Switzerland
+41 (0)61 265 2525
Happy.Mueller@unibas.ch
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University Hospital Basel - Clinic of Endocrinology, Basel Institute of Clinical Epidemiology (BICE), Dept. of Internal Medicine, Dept. of Central Laboratories (infrastructure)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
BRAHMS AG, Hennigsdorf, Germany (assay material)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
Alternative name(s)
Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF, SNSF, FNS
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2005 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/16107222
2008 results in: https://www.ncbi.nlm.nih.gov/pubmed/18852401
2016 secondary analysis in: https://www.ncbi.nlm.nih.gov/pubmed/27009083