CAP-China PCT-AECOPD
Trial question
What is the role of procalcitonin-guided antibiotic therapy in patients with acute exacerbation of COPD?
Study design
Multi-center
Open label
RCT
Population
455 patients.
Inclusion criteria: patients with acute exacerbation of COPD.
Key exclusion criteria: fever; pneumonia; severe respiratory failure requiring admission to ICU; concurrent infection at another site; immunosuppression secondary to chemotherapy, AIDS, or hematologic malignancy; comorbidities requiring corticosteroids; invasive mechanical ventilation.
Interventions
N=229 procalcitonin-guided therapy (clinical decision of antibiotic prescription based on the results of procalcitonin).
N=226 GOLD-guided therapy (clinical decision of antibiotic prescription based on the recommendations of Global Initiative for Chronic Obstructive Lung Disease guideline).
Primary outcome
Rate of antibiotic prescription for acute exacerbation of chronic obstructive pulmonary disease by day 30
38%
59%
59.0 %
44.3 %
29.5 %
14.8 %
0.0 %
Procalcitonin-guided
therapy
GOLD-guided
therapy
Significant
decrease ▼
NNT = 4
Significant decrease in the rate of antibiotic prescription for acute exacerbation of COPD by day 30 (38% vs. 59%; ARD -21, 95% CI -30 to -12).
Secondary outcomes
Borderline significant increase in the rate of clinical treatment success rate by day 30 (97% vs. 94%; AD 4%, 95% CI 0 to 7).
Significant decrease in antibiotic prescription rate during hospitalization (37% vs. 59%; ARD -22, 95% CI -31 to -13).
Significant decrease in antibiotic use during hospitalization (2.63 days vs. 4.86 days; AD -2.23 days, 95% CI -1.35 to -3.11).
Conclusion
In patients with acute exacerbation of COPD, procalcitonin-guided therapy was superior to GOLD-guided therapy with respect to the rate of antibiotic prescription for acute exacerbation of COPD by day 30.
Reference
Weili Sheng, Lixue Huang, Xiaoying Gu et al. Procalcitonin-guided use of antibiotic in hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease: a randomized clinical trial. Clin Microbiol Infect. 2025 May;31(5):785-792.
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