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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 10.1186/ISRCTN40854211
ClinicalTrials.gov identifier
EudraCT number
Public title Registry of procalcitonin-guided antibiotic therapy in patients with lower respiratory tract infections outside of study conditions: “Pro-REAL” - a “real-life" survey
Scientific title
Acronym ProREAL
Serial number at source N/A
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.
Lay summary Not provided at time of registration
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
Countries of recruitment France, Switzerland
Disease/condition/study domain Respiratory tract infections
Participants - 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
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 10/09/2009
Anticipated end date 09/09/2011
Status of trial Completed
Patient information material Patient information (in English, French and German) can be found at: http://www.proreal.li/
Target number of participants 1,200
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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.
Sources of funding 1. Aarau Hospital (Switzerland)
2. BioMerieux (France) provides the procalcitonin test kits
Trial website http://www.proreal.li/
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22782201
Contact name Dr  Werner  Albrich
  Address Tellstrasse
Kantonsspital Aarau
  City/town Aarau
  Zip/Postcode 5001
  Country Switzerland
Sponsor BioMérieux (France)
  Address Chemin de l'Orme
  City/town Marcy l'Étoile
  Zip/Postcode 69280
  Country France
  Sponsor website: http://www.biomerieux.com/servlet/srt/bio/portail/home
Date applied 18/09/2009
Last edited 17/07/2012
Date ISRCTN assigned 16/10/2009
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