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The efficacy and safety of tazobactam/ceftolozane in combination with metronidazole in Japanese patients with complicated intra-abdominal infections.
J Infect Chemother. 2019 Feb; 25(2):111-116.JI

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.

Authors+Show Affiliations

Department of Clinical Infectious Diseases, Aichi Medical University Hospital, Japan.Fukuyama City Hospital, Japan.Yamanashi Prefectural Central Hospital, Japan.National Hospital Organization Osaka Minami Medical Center, Japan.Japan Development, MSD K.K., Tokyo, Japan.Japan Development, MSD K.K., Tokyo, Japan.Japan Development, MSD K.K., Tokyo, Japan.Global Clinical Development, Merck & Co., Inc., Kenilworth, NJ, USA.Japan Development, MSD K.K., Tokyo, Japan. Electronic address: toshiyuki.shizuya@merck.com.

Pub Type(s)

Clinical Trial, Phase III
Journal Article

Language

eng

PubMed ID

30528561

Citation

Mikamo, Hiroshige, et al. "The Efficacy and Safety of Tazobactam/ceftolozane in Combination With Metronidazole in Japanese Patients With Complicated Intra-abdominal Infections." Journal of Infection and Chemotherapy : Official Journal of the Japan Society of Chemotherapy, vol. 25, no. 2, 2019, pp. 111-116.
Mikamo H, Monden K, Miyasaka Y, et al. The efficacy and safety of tazobactam/ceftolozane in combination with metronidazole in Japanese patients with complicated intra-abdominal infections. J Infect Chemother. 2019;25(2):111-116.
Mikamo, H., Monden, K., Miyasaka, Y., Horiuchi, T., Fujimoto, G., Fukuhara, T., Yoshinari, T., Rhee, E. G., & Shizuya, T. (2019). The efficacy and safety of tazobactam/ceftolozane in combination with metronidazole in Japanese patients with complicated intra-abdominal infections. Journal of Infection and Chemotherapy : Official Journal of the Japan Society of Chemotherapy, 25(2), 111-116. https://doi.org/10.1016/j.jiac.2018.10.012
Mikamo H, et al. The Efficacy and Safety of Tazobactam/ceftolozane in Combination With Metronidazole in Japanese Patients With Complicated Intra-abdominal Infections. J Infect Chemother. 2019;25(2):111-116. PubMed PMID: 30528561.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The efficacy and safety of tazobactam/ceftolozane in combination with metronidazole in Japanese patients with complicated intra-abdominal infections. AU - Mikamo,Hiroshige, AU - Monden,Kazuteru, AU - Miyasaka,Yoshiaki, AU - Horiuchi,Tetsuya, AU - Fujimoto,Go, AU - Fukuhara,Takahiro, AU - Yoshinari,Tomoko, AU - Rhee,Elizabeth G, AU - Shizuya,Toshiyuki, Y1 - 2018/12/06/ PY - 2018/08/23/received PY - 2018/10/15/revised PY - 2018/10/17/accepted PY - 2018/12/12/pubmed PY - 2019/3/26/medline PY - 2018/12/12/entrez KW - Ceftolozane KW - Complicated intra-abdominal infection KW - ESBL KW - Japanese patients SP - 111 EP - 116 JF - Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy JO - J Infect Chemother VL - 25 IS - 2 N2 - 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. SN - 1437-7780 UR - https://www.unboundmedicine.com/medline/citation/30528561/The_efficacy_and_safety_of_tazobactam/ceftolozane_in_combination_with_metronidazole_in_Japanese_patients_with_complicated_intra_abdominal_infections_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1341-321X(18)30425-2 DB - PRIME DP - Unbound Medicine ER -