Plain English Summary

Not provided at time of registration

Trial website

http://www.proreal.li/

Contact information

Type

Scientific

Primary contact

Dr Werner Albrich

ORCID ID

Contact details

Tellstrasse
Kantonsspital Aarau
Aarau
5001
Switzerland

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 measures

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

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

http://www.biomerieux.com/servlet/srt/bio/portail/home

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22782201

Publication citations

  1. 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.

Editorial Notes