Condition category
Respiratory
Date applied
18/01/2005
Date assigned
15/02/2005
Last edited
07/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Swiss National Science Foundation (grant approval pending)

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

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

Results - basic reporting

Publication summary

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

Publication citations

Additional files

Editorial Notes

07/10/2016: Publication reference added.