Procalcitonin-guided antibiotic use in Acute Respiratory Tract Infections (ARTIs) in primary care

ISRCTN	ISRCTN73182671
DOI	https://doi.org/10.1186/ISRCTN73182671
ClinicalTrials.gov (NCT)	NCT00099840
Protocol serial number	EKBB 254/04
Sponsor	University Hospital Basel (Switzerland)
Funders	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), Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung

Submission date: 18/01/2005
Registration date: 15/02/2005
Last edited: 20/09/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Beat Muller
Scientific

University Hospital
Petersgraben 4
Basel
4031
Switzerland

Phone	+41 (0)61 265 2525
Email	Happy.Mueller@unibas.ch

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Procalcitonin-guided antibiotic use in Acute Respiratory Tract Infections (ARTIs) in primary care
Study acronym	PARTI-Study
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Days with restrictions from ARTI
Key secondary outcome measure(s)	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
Completion date	31/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	400
Key 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
Key exclusion criteria	1. Patients without informed consent 2. Not fluent in German 3. Antibiotic pretreatment in previous 28 days 4. Severe immune-suppression
Date of first enrolment	01/12/2004
Date of final enrolment	31/03/2006

Locations

Countries of recruitment

Switzerland

Study participating centre

University Hospital Basel

Basel
4031
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	13/10/2008		Yes	No
Protocol article	protocol	18/08/2005		Yes	No
Other publications	secondary analysis	24/03/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/10/2016: Publication reference added.