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
Scientific
University Hospital
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 (0)61 265 2525 |
|---|---|
| Happy.Mueller@unibas.ch |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a 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 | 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 study start date | 01/12/2004 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
4031
Switzerland
Sponsor information
University Hospital Basel (Switzerland)
University/education
University/education
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 (0)61 265 2525 |
|---|---|
| Happy.Mueller@unibas.ch | |
"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)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
