Procalcitonin-guided antibiotic therapy in acute exacerbations of chronic obstructive pulmonary disease (COPD) (AECOPD): a randomised trial - The ProCOLD Study

ISRCTN	ISRCTN77261143
DOI	https://doi.org/10.1186/ISRCTN77261143
Protocol serial number	N/A
Sponsor	University Hospital Basel (Switzerland)
Funder	University Hospital Basel, Pneumology Department (Switzerland)

Submission date: 24/03/2005
Registration date: 10/05/2005
Last edited: 12/08/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Michael Tamm
Scientific

University Hospital Basel
Pneumology
Petersgraben 4
Basel
4031
Switzerland

Phone	+41 (0)61 265 5184
Email	mtamm@uhbs.ch

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PROCOLD
Study objectives	This study aimed to evaluate the outcome of acute exacerbations of COPD (AECOPD) comparing a standard with a procalcitonin (PCT)-guided antibiotic approach.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Acute exacerbations of chronic obstructive pulmonary disease (COPD)
Intervention	At presentation patients will be randomly assigned to the procalcitonin-guided therapy group or to the standard-group. In the ProCT-group, antibiotic therapy will be discouraged (ProCT less than 0.1 ng/ml) or encouraged (ProCT greater than 0.25 ng/ml) based on ProCT levels. In the standard group therapy will be left to the discretion of the treating physician. A standardised work-up including C-reactive protein (CRP), white blood cell count (WBC), sputum/bronchoalveolar lavage (BAL) bacteriology, viral serology, blood cultures, spirometry, chest x-ray and clinical parameters will be undertaken. After 6 months, all patients will be re-evaluated in regard to clinical and laboratory parameters, spirometry and number of AECOPD.
Intervention type	Other
Primary outcome measure(s)	Antibiotic use (% of patients).
Key secondary outcome measure(s)	1. Measures of laboratory and clinical outcome, i.e., serum ProCT and plasma C-reactive protein levels, leukocyte counts, temperature, oxygen saturation, respiratory rate, pulse rate, blood pressure, quality of life indices, length of hospitalisation, complications during the course of disease until follow-up in 14 - 21 days (i.e. need for intensive care unit [ICU] stay, death) 2. Recurrence of exacerbation within 6 months after inclusion in the study including hospitalisation, antibiotics and oral steroids need
Completion date	31/05/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key inclusion criteria	Patients presenting an acute exacerbation of COPD requiring medical therapy in the emergency station of a university hospital in Switzerland.
Key exclusion criteria	Immunosuppression.
Date of first enrolment	23/11/2003
Date of final enrolment	31/05/2005

Locations

Countries of recruitment

Switzerland

Study participating centre

University Hospital Basel

Basel
4031
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	01/01/2007		Yes	No