RESUMO
INTRODUCTION: Duration of antibiotic treatment in acute exacerbation of COPD (AECOPD) is most commonly based on expert opinion. Biomarker guided strategy is increasingly recommended to limit unnecessary antibiotic use. We performed a randomized controlled study to evaluate the efficacy of 2-day versus C-reactive protein (CRP)-guided treatment with levofloxacin in patients with AECOPD. METHODS: Patients with AECOPD were randomized to receive oral levofloxacin daily for 7 days unless the serum CRP level decreased by at least 50% from the baseline value or levofloxacin for two days; thereafter, oral placebo tablet was prescribed according to the CRP. The primary outcome measure was cure rate, and secondary outcome included need for additional antibiotics, intensive care unit (ICU) admission, exacerbation rates and exacerbation free interval (EFI) within one-year follow-up. RESULTS: In intention to treat (ITT) analysis, cure rate was 76.1% (n = 118) and 79.3% (n = 123) respectively in 2-day and CRP-guided groups. In per protocol (PP) analysis, cure rate was 73% (n = 92) and 70.4% (n = 88) respectively in 2-day and CRP-guided groups. The difference between the two groups was not significant. The need for additional antibiotics and ICU admission rates were not significantly different between the two groups. One-year exacerbation rate was 27% (n = 42) in 2-day group versus 30.3% (n = 47) in CRP-guided group (p = 0.53); the EFI was 125 days (interquartile range, 100-151) versus 100 days (interquartile range, 78-123) in 2-day and CRP-guided groups respectively (p = 0.45). No difference in adverse effects was detected. CONCLUSION: Levofloxacin once daily for 2 days had similar efficacy compared to CRP-guided in AECOPD. This short course treatment decreased antibiotic consumption which would improve patient compliance and reduce adverse effects.