Condition category
Respiratory
Date applied
24/03/2005
Date assigned
10/05/2005
Last edited
12/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Tamm

ORCID ID

Contact details

University Hospital Basel
Pneumology
Petersgraben 4
Basel
4031
Switzerland
+41 (0)61 265 5184
mtamm@uhbs.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PROCOLD

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Antibiotic use (% of patients).

Secondary outcome measures

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

Overall trial start date

23/11/2003

Overall trial end date

31/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients presenting an acute exacerbation of COPD requiring medical therapy in the emergency station of a university hospital in Switzerland.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Immunosuppression.

Recruitment start date

23/11/2003

Recruitment end date

31/05/2005

Locations

Countries of recruitment

Switzerland

Trial participating centre

University Hospital Basel
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital Basel (Switzerland)

Sponsor details

Pneumology Department
Petersgraben 4
Basel
4031
Switzerland
+41 (0)61 265 51 84
mtamm@uhbs.ch

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Basel, Pneumology Department (Switzerland)

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17218551

Publication citations

  1. Results

    Stolz D, Christ-Crain M, Bingisser R, Leuppi J, Miedinger D, Müller C, Huber P, Müller B, Tamm M, Antibiotic treatment of exacerbations of COPD: a randomized, controlled trial comparing procalcitonin-guidance with standard therapy., Chest, 2007, 131, 1, 9-19, doi: 10.1378/chest.06-1500.

Additional files

Editorial Notes