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Research Article
Semir Nouira
Fattouma Bourguiba University Hospital
Corresponding Author
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Introduction: Duration of antibiotic treatment in acute exacerbation of COPD (AECOPD) is most commonly based on expert opinion. Typical administration periods range from 5 to 7 days. A 2-day course with levofloxacin was not previously assessed. We performed a randomized clinical trial to evaluate the efficacy of 2-day versus 7-day treatment with levofloxacin in patients with AECOPD.
Methods: Patients with AECOPD were randomized to receive levofloxacin for 2 days and 5 days placebo (n=155) or levofloxacin for 7 days (n=155). The primary outcome measure was cure rate, and secondary outcome included need for additional antibiotics, ICU admission, reexacerbation rates and exacerbation free interval (EFI) within one year follow-up.
Results: In ITT analysis, cure rate was 79.3% (n=123) and 74.2% (n=115) respectively in 2-day and 7-day groups. In PP analysis, cure rate was 78% (n=92) and 69% (n=82) respectively in 2-day and 7-day groups. The difference between both groups was not significant. The need for additional antibiotics and ICU admission rates were not significantly different between both groups. One-year reexacerbation rate was 34.8% (n=54) in 2-day group versus 29% (n=45) in 7-day group (p=0.19); the EFI was 121 days (interquartile range, 99-149) versus 110 days (interquartile range, 89-132) in 2-day and 7-day treatment groups respectively (p=0.73). No difference in adverse effects was detected.
Conclusion: Levofloxacin once daily for 2 days is not inferior to 7 days with respect to cure rate and hospital readmission in COPD exacerbations. Our finings would improve patient compliance and reduce the incidence of bacterial resistance and adverse effects.
Keywords
Levofloxacin, acute exacerbation of COPD, Duration, 2-Days, 7-Days
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No competing interests reported.
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A new preprint design is coming!
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This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Research Article
Semir Nouira
Fattouma Bourguiba University Hospital
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Version 1
Posted 27 May, 2021
No community comments so far
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Pulmonology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Introduction: Duration of antibiotic treatment in acute exacerbation of COPD (AECOPD) is most commonly based on expert opinion. Typical administration periods range from 5 to 7 days. A 2-day course with levofloxacin was not previously assessed. We performed a randomized clinical trial to evaluate the efficacy of 2-day versus 7-day treatment with levofloxacin in patients with AECOPD.
Methods: Patients with AECOPD were randomized to receive levofloxacin for 2 days and 5 days placebo (n=155) or levofloxacin for 7 days (n=155). The primary outcome measure was cure rate, and secondary outcome included need for additional antibiotics, ICU admission, reexacerbation rates and exacerbation free interval (EFI) within one year follow-up.
Results: In ITT analysis, cure rate was 79.3% (n=123) and 74.2% (n=115) respectively in 2-day and 7-day groups. In PP analysis, cure rate was 78% (n=92) and 69% (n=82) respectively in 2-day and 7-day groups. The difference between both groups was not significant. The need for additional antibiotics and ICU admission rates were not significantly different between both groups. One-year reexacerbation rate was 34.8% (n=54) in 2-day group versus 29% (n=45) in 7-day group (p=0.19); the EFI was 121 days (interquartile range, 99-149) versus 110 days (interquartile range, 89-132) in 2-day and 7-day treatment groups respectively (p=0.73). No difference in adverse effects was detected.
Conclusion: Levofloxacin once daily for 2 days is not inferior to 7 days with respect to cure rate and hospital readmission in COPD exacerbations. Our finings would improve patient compliance and reduce the incidence of bacterial resistance and adverse effects.
Figure 1
Figure 2
No competing interests reported.
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