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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN77261143

Enrollment

200

Registered

2005-05-10

Start date

2003-11-23

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute exacerbations of chronic obstructive pulmonary disease (COPD) Respiratory Chronic obstructive pulmonary disease (COPD)

Interventions

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 n

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Immunosuppression.

Design outcomes

Primary

Measure	Time frame
Antibiotic use (% of patients).	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026