| Methods |
Randomised, single‐centre clinical trial in an ED of a university hospital in Denmark |
| Participants |
Inclusion criteria: 1) 18 years old and 2) admitted with an AECOPD (clinician’s diagnosis at admission), defined according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
Exclusion criteria: 1) person unable to understand or respond to oral or written information; 2) previously been enrolled in the study; and 3) do‐not‐resuscitate order in place
Included in this analysis: 120/630 screened people with AECOPD were randomised and used for the ITT analysis (62 in the PCT group, 58 in the control group). |
| Interventions |
The aim was to assess whether PCT‐guided antibiotic treatment could reduce the overall use of antibiotics among people hospitalised for AECOPD.
Algorithm used in this study: In the control group, antibiotic therapy followed treatment strategies for AECOPD according to GOLD guidelines. In the PCT group, initiation or continuation of antibiotics was strongly discouraged if PCT was 0.15 ng/mL or lower and discouraged if levels were between 0.15 ng/mL and 0.25 ng/mL. Initiation or continuation of antibiotics was encouraged if PCT was > 0.25 ng/mL. In participants with PCT over 5 ng/mL on admission, the algorithm recommended stopping antibiotics when PCT levels decreased by 80% of the peak value. |
| Outcomes |
fraction of participants using antibiotics for at least 5 days within 28 days after inclusion cumulative number of days with any antibiotic therapy within 28 days fraction of participants using antibiotics for a) at least 1 day, b) at least 3 days, c) at least 7 days length of hospital stay adverse events (composite endpoint of mortality, readmission, ICU admission all within 28 days |
| Notes |
Funding: Thermo Fisher Scientific, MA, USA, and bioMérieux Denmark ApS supported the study non‐financially.
Follow‐up: 28 days
Registration: NCT01950936
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Participants were allocated according to the random part of the civil registration number in Denmark |
| Allocation concealment (selection bias) |
Low risk |
The randomisation algorithm was concealed to treating clinicians and participants |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Blinding was not feasible, but PCT was only measured in the intervention arm |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
No mentioning of blinding |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Follow‐up for mortality: 120/120 (100%) |
| Selective reporting (reporting bias) |
Low risk |
Outcomes correspond to study protocol. Trial registered (NCT01950936) |
| Other bias |
High risk |
Moderate adherence to the PCT algorithm in PCT group (61.1%) |
