Vol.65 No.2 March 2017

A multicenter randomized controlled study on the efficacy of moxifloxacin and garenoxacin for the treatment of adult community-acquired pneumonia

Yoshifumi Imamura¹⁾, Akitaka Tanaka²⁾, Masato Tashiro²⁾, Tomomi Saijo¹⁾, Kazuko Yamamoto¹⁾, Taiga Miyazaki¹⁾, Misuzu Tsukamoto³⁾, Koichi Izumikawa²⁾, Katsunori Yanagihara⁴⁾, Hiroshi Mukae¹⁾ and Shigeru Kohno⁵⁾

¹⁾Second Department of Internal Medicine, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki, Japan
²⁾Nagasaki University Infection Control and Education Center, Nagasaki University Hospital
³⁾Department of Respiratory Medicine, Hokusho Central Hospital
⁴⁾Department of Laboratory Medicine, Nagasaki University Hospital
⁵⁾Nagasaki University

Abstract

The clinical efficacy and safety of moxifloxacin (MFLX) and garenoxacin (GRNX), two respiratory quinolones used as key outpatient treatments for community-acquired pneumonia, were compared in a prospective multicenter randomized controlled study. The study involved 120 adults with mild or moderate community-acquired pneumonia who had visited the Second Department of Internal Medicine of Nagasaki University Hospital or any of 12 associated hospitals between May 2011 and April 2013. The subjects were randomly assigned to receive either MFLX (400 mg/day) or GRNX (400 mg/day); after up to 10 days of oral administration, the efficacy and safety results were compared between the two groups. The numbers of subjects in each analysis set were as follows: efficacy analysis, 111 (MFLX, 54; GRNX, 57); clinical efficacy at the end of treatment, 111 (MFLX, 54; GRNX, 57); bacteriological efficacy analysis, 52 (MFLX, 23; GRNX, 29); and safety analysis, 120 (MFLX, 59; GRNX, 61). The efficacy rate on the 5th to 10th day of post-treatment, defined as the primary endpoint, was 88.9% for the MFLX group and 89.5% for the GRNX group, with no statistically significant difference between the groups. Secondary endpoints, consisting of the efficacy rate on the 3rd day after the initiation of treatment (77.8% for MFLX vs. 73.7% for GRNX), the efficacy rate at the end of treatment (96.3% for MFLX vs. 93.0% for GRNX), and the bacteriological eradication rate (82.6% for MFLX vs. 96.6% for GRNX) were also comparable for both groups, with no statistically significant difference. The incidences of adverse events in the MFLX and GRNX groups were 27.1% and 31.1%, respectively, and no serious adverse events were observed. These results indicate that for the outpatient treatment of adults with mild or moderate community-acquired pneumonia, MFLX and GRNX are comparable with regard to their clinical efficacy and safety.

Key word

moxifloxacin, garenoxacin, community-acquired pneumonia

Received

July 11, 2016

Accepted

October 26, 2016

Jpn. J. Chemother. 65 (2): 168-174, 2017