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Abstract

Vol.65 No.3 May 2017

Clinical study of levofloxacin injection in peritonitis patients

Yoshio Takesue1), Keiji Oe2), Yasuyuki Okuda2), Kazuo Aisaki3), Yasuyuki Kawachi4), Junzo Shimizu5), Koji Okamoto6) and Hiroshige Mikamo7)

1)Department of Infection Prevention and Control, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
2)R&D Division, Daiichi Sankyo Co., Ltd.
3)Department of Surgery, Sagamihara Kyodo Hospital
4)Department of Surgery, Nagaoka Chuo General Hospital
5)Department of Surgery, Osaka Rosai Hospotal
6)Department of Surgery, Kitakyushu City Yahata Hospital
7)Department of Clinical Infectious Diseases, Aichi Medical University Hospital

Abstract

We evaluated the efficacy and safety of the intravenous infusion of 500 mg of levofloxacin (LVFX) once daily for 3-14 days in patients with peritonitis or peritonitis caused by pelvic inflammatory disease (PID). Additionally, drug penetration into the peritoneal exudate after the injection of 500 mg of LVFX was determined in patients with peritonitis.
Clinical efficacy: The clinical efficacy rates at the test of cure (primary endpoint) for the patients with peritonitis and peritonitis caused by PID were 61.5% (8/13) and 100.0% (4/4), respectively. Patients with peritonitis and abscess formation were evaluated as cases in which treatment had failed. LVFX monotherapy might not have been effective in these patients because of the presence of intra-abdominal abscesses caused by anaerobic bacteria.
Microbiological efficacy: The microbiological efficacy rates at the end of treatment in patients with peritonitis and peritonitis caused by PID were 50.0% (4/8) and 75.0% (3/4), respectively.
Pharmacokinetics: The concentration of LVFX in the peritoneal exudate reached a peak at 7-9 h after the start of infusion, with a mean value of 12.9 μg/g (range: 5.7-18.5 μg/g). The mean peritoneal exudate to plasma concentration ratio was 1.95 (range: 1.35-2.30).
Safety: The incidences of adverse events (AEs) and adverse drug reactions (ADRs) were 71.4% (15/21) and 28.6% (6/21), respectively. The only ADR that occurred in two or more patients was erythema at the injection site. The severities of all the ADRs were mild, and all the patients with an ADR recovered.
These results suggest that the injection of 500 mg of LVFX once daily was useful for the treatment of peritonitis (including peritonitis caused by PID), and no significant safety problems were seen. In addition, based on our observations, concomitant treatment with anti-anaerobic agents might be necessary in cases of peritonitis with abscess formation, in which anaerobic bacteria exhibit significant pathogenicity.

Key word

levofloxacin, peritonitis, pelvic inflammatory disease

Received

July 8, 2016

Accepted

October 28, 2016

Jpn. J. Chemother. 65 (3): 456-468, 2017