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
Secondary identifying numbers	N/A

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

Study website

Contact information

Dr Werner Albrich
Scientific

Tellstrasse
Kantonsspital Aarau
Aarau
5001
Switzerland

Study information

Study design	Observational prospective longitudinal study
Primary study design	Observational
Secondary study design	Multi-centre
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Patient information (in English, French and German) can be found at: http://www.proreal.li/
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	Duration of antibiotic treatment All primary and secondary outcome measures will be assessed by a telephone interview 30 days after the start of the treatment.
Secondary outcome measures	1. Adherence to procalcitonin algorithm 2. Adverse medical outcomes (complications, mortality, relapse, intensive care unit [ICU] admission) 3. Antibiotic side effects 4. Length of hospital stay 5. Differences between procalcitonin (PCT) levels measured by KRYPTOR® and VIDAS® All primary and secondary outcome measures will be assessed by a telephone interview 30 days after the start of the treatment.
Overall study start date	10/09/2009
Completion date	09/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	1,200
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

Sponsor information

BioMérieux (France)
Industry

Chemin de l'Orme
Marcy l'Étoile
69280
France

Website	http://www.biomerieux.com/servlet/srt/bio/portail/home
"ROR"	https://ror.org/03hf69k85

Funders

Funder type

Hospital/treatment centre

Aarau Hospital (Switzerland)

No information available

BioMerieux (France) provides the procalcitonin test kits