Two-day seven-day course of levofloxacin in acute COPD exacerbation: a randomized controlled trial

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 and analysis: Patients with AECOPD were randomized to receive levofloxacin for 2 days and 5 days placebo ( n  = 155) or levofloxacin for 7 days ( n  = 155). All patients received a common dose of intravenous prednisone daily for 5 days. The primary outcome measure was cure rate, and secondary outcomes included need for additional antibiotics, ICU admission rate, re-exacerbation rate, death rate, and exacerbation-free interval (EFI) within 1-year follow-up. The study protocol has been prepared in accordance with the revised Helsinki Declaration for Biomedical Research Involving Human Subjects and Guidelines for Good Clinical Practice. The study was approved by ethics committees of all participating centers prior to implementation (Monastir and Sousse Universities). Results: 310 patients were randomized to receive 2-day course of levofloxacin ( n  = 155) or 7-day course ( n  = 155). Cure rate was 79.3% ( n  = 123) and 74.2% ( n  = 115), respectively, in 2-day and 7-day groups [OR 1.3; 95% CI 0.78–2.2 ( p  = 0.28)]. Need for additional antibiotics rate was 3.2% and 1.9% in the 2-day group and 7-day group, respectively; ( p  = 0.43). ICU admission rate was not significantly different between both groups. One-year re-exacerbation 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). One-year death rate was not significantly different between the 2 groups, 5.2% versus 7.1% in the 2-day group and 7-day group, respectively; ( p  = 0.26). 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, need for additional antibiotics and hospital readmission in AECOPD. Our findings would improve patient compliance and reduce the incidence of bacterial resistance and adverse effects

Value of inferior vena cava collapsibility index as marker of heart failure in chronic obstructive pulmonary disease exacerbation

Abstract Introduction Inferior vena cava (IVC) diameter variability with respiration measured by ultrasound was found to be useful for the diagnosis of heart failure (HF) in ED patients with acute dyspnea. Its value in identifying HF in acute exacerbation of chronic obstructive pulmonary disease exacerbation (AECOPD) was not specifically demonstrated. Objective To determine the value of ΔIVC in the diagnosis of HF patients with AECOPD. Methods This is a prospective study conducted in the ED of three Tunisian university hospitals including patients with AECOPD. During this period, 401 patients met the inclusion criteria. The final diagnosis of HF is based on the opinion of two emergency experts after consulting the data from clinical examination, cardiac echocardiography, and BNP level. The ΔIVC was calculated by two experienced emergency physicians who were blinded from the patient’s clinical and laboratory data. A cut off of 15% was used to define the presence (< 15%) or absence of HF (≥ 15%). Left ventricular ejection fraction (LVEF) was also measured. The area under the ROC curve, sensitivity, specificity, and positive and negative predictive values were calculated to determine the diagnostic and predictive accuracy of the ΔIVC in predicting HF. Results The study population included 401 patients with AECOPD, mean age 67.2 years with male (68.9%) predominance. HF was diagnosed in 165 (41.1%) patients (HF group) and in 236 patients (58.9%) HF was excluded (non HF group). The assessment of the performance of the ΔIVC in the diagnosis of HF showed a sensitivity of 37.4% and a specificity of 89.7% using the threshold of 15%. The positive predictive value was 70.9% and the negative predictive value was 66.7%. The area under the ROC curve was 0.71(95%, CI 0.65–0.76). ΔIVC values were not different between HF patients with reduced LVEF and those with preserved LVEF. Conclusion Our results showed that ΔIVC has a good value for ruling out HF in ED patients consulting for AECOPD

2-Day versus C-reactive protein guided antibiotherapy with levofloxacin in acute COPD exacerbation: A randomized controlled trial.

IntroductionDuration 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.MethodsPatients 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.ResultsIn 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.ConclusionLevofloxacin 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