OBJECTIVES: Short-course therapy has been advocated for the treatment of community-acquired pneumonia (CAP). We compared the efficacy and safety of 5 and 7 day courses of gemifloxacin for outpatient treatment of mild-moderate CAP. PATIENTS AND METHODS: In a multicentre, double-blind, parallel group study, patients were randomized to receive 320 mg of oral gemifloxacin once daily for 5 or 7 days. Over 95% of all patients in each cohort had a Fine score of <or=III. The primary efficacy endpoint was clinical cure at follow-up (days 24-30). Secondary outcomes were clinical and bacteriological responses at the end of therapy (days 7-9) and bacteriological and radiological responses at follow-up. Adverse events (AEs) were also monitored. RESULTS: In a total of 469 per protocol (PP) patients, clinical resolution at follow-up was 95% and 92% for 5 and 7 day treatments, respectively [95% confidence interval (CI) -1.48, 7.42], indicating non-inferiority of 5 day treatment. Clinical resolution at the end of therapy was 96% for both regimens (95% CI -3.85, 3.42). Bacteriological response rates in PP patients at the end of therapy were 94% and 96% for 5 and 7 day groups, respectively (95% CI -8.27, 3.25) and 91% for both groups at follow-up (95% CI -6.89, 7.93). Radiological success in PP patients at follow-up was 98% and 93% in 5 and 7 day groups, respectively (95% CI 0.35, 7.91). Pre-therapy pathogens were identified in 242 (47.3%) patients, most commonly Streptococcus pneumoniae. Frequency of treatment-related AEs was 21% in both cohorts with discontinuation rates of 1.2% and 2% in the 5 and 7 day groups, respectively. A lower incidence of rash was observed in the 5 day cohort (0.4%) versus the 7 day cohort (2.8%) (P=0.04). CONCLUSIONS:Gemifloxacin once daily for 5 days is not inferior to 7 days in the PP population with respect to clinical, bacteriological and radiological efficacy. Further work is needed, however, to explore whether fewer treatment days would improve patient compliance and reduce the incidence of AEs.
RCT Entities:
OBJECTIVES: Short-course therapy has been advocated for the treatment of community-acquired pneumonia (CAP). We compared the efficacy and safety of 5 and 7 day courses of gemifloxacin for outpatient treatment of mild-moderate CAP. PATIENTS AND METHODS: In a multicentre, double-blind, parallel group study, patients were randomized to receive 320 mg of oral gemifloxacin once daily for 5 or 7 days. Over 95% of all patients in each cohort had a Fine score of <or=III. The primary efficacy endpoint was clinical cure at follow-up (days 24-30). Secondary outcomes were clinical and bacteriological responses at the end of therapy (days 7-9) and bacteriological and radiological responses at follow-up. Adverse events (AEs) were also monitored. RESULTS: In a total of 469 per protocol (PP) patients, clinical resolution at follow-up was 95% and 92% for 5 and 7 day treatments, respectively [95% confidence interval (CI) -1.48, 7.42], indicating non-inferiority of 5 day treatment. Clinical resolution at the end of therapy was 96% for both regimens (95% CI -3.85, 3.42). Bacteriological response rates in PP patients at the end of therapy were 94% and 96% for 5 and 7 day groups, respectively (95% CI -8.27, 3.25) and 91% for both groups at follow-up (95% CI -6.89, 7.93). Radiological success in PP patients at follow-up was 98% and 93% in 5 and 7 day groups, respectively (95% CI 0.35, 7.91). Pre-therapy pathogens were identified in 242 (47.3%) patients, most commonly Streptococcus pneumoniae. Frequency of treatment-related AEs was 21% in both cohorts with discontinuation rates of 1.2% and 2% in the 5 and 7 day groups, respectively. A lower incidence of rash was observed in the 5 day cohort (0.4%) versus the 7 day cohort (2.8%) (P=0.04). CONCLUSIONS:Gemifloxacin once daily for 5 days is not inferior to 7 days in the PP population with respect to clinical, bacteriological and radiological efficacy. Further work is needed, however, to explore whether fewer treatment days would improve patient compliance and reduce the incidence of AEs.
Authors: George Dimopoulos; Dimitrios K Matthaiou; Drosos E Karageorgopoulos; Alexandros P Grammatikos; Zoe Athanassa; Matthew E Falagas Journal: Drugs Date: 2008 Impact factor: 9.546
Authors: Jesús López-Alcalde; Ricardo Rodriguez-Barrientos; Jesús Redondo-Sánchez; Javier Muñoz-Gutiérrez; José María Molero García; Carmen Rodríguez-Fernández; Julio Heras-Mosteiro; Jaime Marin-Cañada; Jose Casanova-Colominas; Amaya Azcoaga-Lorenzo; Virginia Hernandez Santiago; Manuel Gómez-García Journal: Cochrane Database Syst Rev Date: 2018-09-06
Authors: Angela Huttner; Werner C Albrich; Pierre-Yves Bochud; Angèle Gayet-Ageron; Anne Rossel; Elodie von Dach; Stephan Harbarth; Laurent Kaiser Journal: BMJ Open Date: 2017-07-13 Impact factor: 2.692