Registry of procalcitonin-guided antibiotic therapy in patients with lower respiratory tract infections outside of study conditions: Pro-REAL - a real-life" survey
| ISRCTN | ISRCTN40854211 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40854211 |
| Protocol serial number | N/A |
| Sponsor | BioMérieux (France) |
| Funders | Aarau Hospital (Switzerland), BioMerieux (France) provides the procalcitonin test kits |
- Submission date
- 18/09/2009
- Registration date
- 16/10/2009
- Last edited
- 17/07/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Werner Albrich
Scientific
Scientific
Tellstrasse
Kantonsspital Aarau
Aarau
5001
Switzerland
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational prospective longitudinal study |
| Secondary study design | Multi-centre |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | ProREAL |
| Study objectives | Duration of antibiotic therapy for patients with lower respiratory tract infections can be shortened by application of a procalcitonin-based algorithm in real-life conditions. |
| Ethics approval(s) | Switzerland: 1. Ethics Committee of Aargau (Kantonale Ethikkommission Kanton Aargau) (EKAG), approved on 06/10/2008 (ref: 2006/48) 2. Ethics Committee of Basel (Ethikkommission Beider Basel) (EKBB), approved on 29/07/2008 (ref: 236/08) Ethics approvals for trial centres in France: Pending as of 18/09/2009 |
| Health condition(s) or problem(s) studied | Respiratory tract infections |
| Intervention | The participants will be contacted approximately 30 days after the start of the treatment to conduct a telephone interview lasting approximately 10 minutes. They will be asked about any persisting complaints, possible side-effects of the antibiotics (such as diarrhoea and nausea) and recurrence of the respiratory tract infection with or without antibiotic treatment. They will also be asked whether they had to visit the GP or the hospital, and if so, how many times. |
| Intervention type | Other |
| Primary outcome measure(s) |
Duration of antibiotic treatment |
| Key secondary outcome measure(s) |
1. Adherence to procalcitonin algorithm |
| Completion date | 09/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1200 |
| Key inclusion criteria | 1. Both males and females, age >18 2. Lower respiratory tract infection (at least one respiratory symptom [cough, sputum production, dyspnea, tachypnea, pleuritic pain]) PLUS 3. One of the following auscultatory finding or sign of infection: 3.1. Core body temperature >38°C or <36°C 3.2. Shivers 3.3. Leukocyte count >10 g/L or <4 g/L cells |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 10/09/2009 |
| Date of final enrolment | 09/09/2011 |
Locations
Countries of recruitment
- France
- Switzerland
Study participating centre
Tellstrasse
Aarau
5001
Switzerland
5001
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/05/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
