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

ISRCTN ISRCTN73182671
DOI https://doi.org/10.1186/ISRCTN73182671
ClinicalTrials.gov number NCT00099840
Secondary identifying numbers EKBB 254/04
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleProcalcitonin-guided antibiotic use in Acute Respiratory Tract Infections (ARTIs) in primary care
Study acronymPARTI-Study
Study objectivesAcute 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) studiedAcute respiratory tract infections
InterventionAll 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 typeOther
Primary outcome measureDays with restrictions from ARTI
Secondary outcome measures1. 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 study start date01/12/2004
Completion date31/03/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants400
Key inclusion criteria18 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 criteria1. Patients without informed consent
2. Not fluent in German
3. Antibiotic pretreatment in previous 28 days
4. Severe immune-suppression
Date of first enrolment01/12/2004
Date of final enrolment31/03/2006

Locations

Countries of recruitment

  • Switzerland

Study participating centre

University Hospital Basel
Basel
4031
Switzerland

Sponsor information

University Hospital Basel (Switzerland)
University/education

Petersgraben 4
Basel
4031
Switzerland

Phone +41 (0)61 265 2525
Email Happy.Mueller@unibas.ch
ROR logo "ROR" https://ror.org/04k51q396

Funders

Funder type

University/education

University Hospital Basel - Clinic of Endocrinology, Basel Institute of Clinical Epidemiology (BICE), Dept. of Internal Medicine, Dept. of Central Laboratories (infrastructure)

No information available

BRAHMS AG, Hennigsdorf, Germany (assay material)

No information available

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
Location
Switzerland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

07/10/2016: Publication reference added.