Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
ProREAL
Study hypothesis
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
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
Study design
Observational prospective longitudinal study
Primary study design
Observational
Secondary study design
Multi-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Patient information (in English, French and German) can be found at: http://www.proreal.li/
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
10/09/2009
Overall trial end date
09/09/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1,200
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
10/09/2009
Recruitment end date
09/09/2011
Locations
Countries of recruitment
France, Switzerland
Trial participating centre
Tellstrasse
Aarau
5001
Switzerland
Sponsor information
Organisation
BioMérieux (France)
Sponsor details
Chemin de l'Orme
Marcy l'Étoile
69280
France
Sponsor type
Industry
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Aarau Hospital (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
BioMerieux (France) provides the procalcitonin test kits
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22782201
Publication citations
-
Results
Albrich WC, Dusemund F, Bucher B, Meyer S, Thomann R, Kühn F, Bassetti S, Sprenger M, Bachli E, Sigrist T, Schwietert M, Amin D, Hausfater P, Carre E, Gaillat J, Schuetz P, Regez K, Bossart R, Schild U, Mueller B, , Effectiveness and safety of procalcitonin-guided antibiotic therapy in lower respiratory tract infections in "real life": an international, multicenter poststudy survey (ProREAL)., Arch. Intern. Med., 2012, 172, 9, 715-722, doi: 10.1001/archinternmed.2012.770.