Tieying Sun1, Li Sun2, Rongmei Wang3, Xiaoping Ren2, Dong-Jiang Sui3, Chun Pu1, Yajuan Ren2, Ying Liu3, Zhuo Yang2, Fengzhi Li3. 1. Department of Respiratory and Critical Care Medicine, Beijing Hospital of the Ministry of Health, Beijing 100730, China. 2. Department of Respiratory Diseases, Shaanxi Provincial People's Hospital, Xi'an, Shaanxi 710068, China. 3. Department of Respiratory Diseases, Air Force General Hospital, People's Liberation Army, Beijing 100142, China.
Abstract
BACKGROUND: Community-acquired pneumonia (CAP) is a common infectious disease throughout the world and the incidence continues to grow as the population ages. Aspiration is an important pathogenic mechanism for pneumonia in the elderly and the management of patients with community-acquired pneumonia with aspiration factors is a major medical problem. Our study aimed to assess whether moxifloxacin in comparison to levofloxacin plus metronidazole are effective and safe in the treatment of community-acquired pneumonia with aspiration factors. METHODS: In this prospective, multicenter, open-label, randomized controlled trial, 77 patients with mild-to-moderate community-acquired pneumonia with aspiration factors were enrolled and randomly assigned to receive moxifloxacin or levofloxacin plus metronidazole. The primary efficacy variables were clinical outcomes in evaluable patients at a follow-up visit 7 to 14 days after the end of therapy. RESULTS: Seven days after the end of therapy a clinical cure was achieved for 76.7% (23 of 37) of efficacy-evaluable patients in the moxifloxacin group and 51.7% (15 of 40) of patients in the levofloxacin plus metronidazole group. There was a significant difference between the two groups (χ(2) = 4.002, P < 0.05). Bacteriological success rates were similar in the moxifloxacin group (93.3%) and levofloxacin plus metronidazole group (96.4%), there was no significant difference between the two groups (P > 0.05). The overall adverse event rate was 10.8% (4/37) in the moxifloxacin group versus 17.5% (7/40) in the levofloxacin plus metronidazole group, there was no significant difference between the two groups (P > 0.05). No serious adverse events were observed. CONCLUSIONS:Moxifloxacin is effective and safe for treatment of community-acquired pneumonia with aspiration factors. And the regimen of moxifloxacin monotherapy is more convenient compared with levofloxacin plus metronidazole.
RCT Entities:
BACKGROUND: Community-acquired pneumonia (CAP) is a common infectious disease throughout the world and the incidence continues to grow as the population ages. Aspiration is an important pathogenic mechanism for pneumonia in the elderly and the management of patients with community-acquired pneumonia with aspiration factors is a major medical problem. Our study aimed to assess whether moxifloxacin in comparison to levofloxacin plus metronidazole are effective and safe in the treatment of community-acquired pneumonia with aspiration factors. METHODS: In this prospective, multicenter, open-label, randomized controlled trial, 77 patients with mild-to-moderate community-acquired pneumonia with aspiration factors were enrolled and randomly assigned to receive moxifloxacin or levofloxacin plus metronidazole. The primary efficacy variables were clinical outcomes in evaluable patients at a follow-up visit 7 to 14 days after the end of therapy. RESULTS: Seven days after the end of therapy a clinical cure was achieved for 76.7% (23 of 37) of efficacy-evaluable patients in the moxifloxacin group and 51.7% (15 of 40) of patients in the levofloxacin plus metronidazole group. There was a significant difference between the two groups (χ(2) = 4.002, P < 0.05). Bacteriological success rates were similar in the moxifloxacin group (93.3%) and levofloxacin plus metronidazole group (96.4%), there was no significant difference between the two groups (P > 0.05). The overall adverse event rate was 10.8% (4/37) in the moxifloxacin group versus 17.5% (7/40) in the levofloxacin plus metronidazole group, there was no significant difference between the two groups (P > 0.05). No serious adverse events were observed. CONCLUSIONS:Moxifloxacin is effective and safe for treatment of community-acquired pneumonia with aspiration factors. And the regimen of moxifloxacin monotherapy is more convenient compared with levofloxacin plus metronidazole.