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The efficacy and safety of tazobactam/ceftolozane in combination with metronidazole in Japanese patients with complicated intra-abdominal infections.
- Source :
-
Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy [J Infect Chemother] 2019 Feb; Vol. 25 (2), pp. 111-116. Date of Electronic Publication: 2018 Dec 06. - Publication Year :
- 2019
-
Abstract
- Tazobactam/ceftolozane, a novel antimicrobial therapy, is active against Pseudomonas aeruginosa and most extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae. We report the results of the efficacy and safety of tazobactam/ceftolozane in Japanese patients with complicated intra-abdominal infections (cIAI). A multicenter, open-label, noncomparative study (MK-7625A Protocol 013, ClinicalTrials.gov Identifier: NCT02739997) to investigate the efficacy and safety of tazobactam/ceftolozane used in combination with metronidazole in Japanese patients with cIAI was conducted. One hundred Japanese patients with cIAI received tazobactam/ceftolozane 1.5 g (tazobactam 0.5 g/ceftolozane 1 g) plus metronidazole 500 mg intravenously every 8 h for 60 min for 4-14 days. The clinical response rate at the Test-of-Cure visit (TOC; Day 28 ± 2 days) was 92.0% (81/88 subjects). By disease type, the clinical response rates were 92.3% (24/26) for cholecystitis, 100% (6/6) for liver abscess, 93.5% (58/62) for intra-abdominal abscess and 90.2% (55/61) for peritonitis. The per-subject microbiological response rate at the TOC was 90.2% (55/61). Per-pathogen microbiological response rates in the most common baseline pathogens were Escherichia coli 90.2% (37/41), Kebsiella pneumoniae 91.7% (11/12), Streptococcus anginosus 100% (11/11), Streptococcus constellatus 90.0% (9/10) and Bacteroides fragilis 95.2% (20/21). The most common drug-related AEs were aspartate aminotransferase increased (11.0%) and alanine aminotransferase increased (9.0%). No serious drug-related AE was reported during the study. The favorable effect of tazobactam/ceftolozane in the treatment of cIAI suggests that the agent will be useful in clinical practice in Japan.<br /> (Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.)
- Subjects :
- Aged
Anti-Bacterial Agents pharmacology
Anti-Bacterial Agents therapeutic use
Bacteria drug effects
Cephalosporins pharmacology
Cephalosporins therapeutic use
Female
Humans
Intraabdominal Infections microbiology
Japan
Male
Metronidazole pharmacology
Metronidazole therapeutic use
Middle Aged
Tazobactam pharmacology
Tazobactam therapeutic use
Treatment Outcome
Anti-Bacterial Agents adverse effects
Cephalosporins adverse effects
Intraabdominal Infections drug therapy
Metronidazole adverse effects
Tazobactam adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1437-7780
- Volume :
- 25
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy
- Publication Type :
- Academic Journal
- Accession number :
- 30528561
- Full Text :
- https://doi.org/10.1016/j.jiac.2018.10.012