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The efficacy and safety of tazobactam/ceftolozane in Japanese patients with uncomplicated pyelonephritis and complicated urinary tract infection.
J Infect Chemother. 2019 Feb; 25(2):104-110.JI

Abstract

We report efficacy and safety results for a combination of a novel cephalosporin class antibiotic and a β-Lactamase inhibitor, tazobactam/ceftolozane (1:2) at a dose of 1.5 g intravenously every 8 h in Japanese patients with uncomplicated pyelonephritis and complicated urinary tract infection. This study design was a nonrandomized, multicenter, open-label trial, and the treatment period was 7 days. Of 115 patients enrolled in this study, 114 received tazobactam/ceftolozane, and 90 were included in the efficacy analyses. Ninety-nine isolates (bacterial count ≥105 CFU/mL) were identified by urine culture. The main baseline uropathogens were Escherichia coli (80 isolates), Klebsiella pneumoniae (8 isolates), and Proteus mirabilis (3 isolates). Of these, 13 isolates were ESBL-producers. The favorable per-patient microbiological response rate at 7 days after the final administration of tazobactam/ceftolozane was 80.7% (71/88). The response rate in uncomplicated pyelonephritis was 90.0% (36/40), complicated pyelonephritis 63.6% (14/22), and complicated cystitis 80.8% (21/26). The favorable clinical response rate was 96.6% (86/89), and composite response rate (based on microbiological and clinical response) was 80.7% (71/88). The eradication rate by uropathogen was 83.5% (66/79) in E. coli, 42.9% (3/7) in K. pneumoniae, and 100% (3/3) in P. mirabilis. The incidence of drug-related adverse events was 17.5% (20/114 patients). The most common drug-related adverse events were diarrhea and alanine aminotransferase increased in 5.3% (6/114 patients each). Drug-related serious adverse events and deaths were not observed. These results support the safety and efficacy of tazobactam/ceftolozane and suggest it will be a useful treatment for uncomplicated pyelonephritis and complicated urinary tract infection.

Authors+Show Affiliations

Sanda City Hospital, Hyogo, Japan.Kawahara Clinic, Kagoshima, Japan.Kawahara Urology Clinic, Kagoshima, Japan.Center for Nutrition Support and Infection Control, Gifu University Hospital, Gifu, Japan.Japan Development, MSD K.K., Tokyo, 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: norihiro.aoyama@merck.com.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study

Language

eng

PubMed ID

30420153

Citation

Arakawa, Soichi, et al. "The Efficacy and Safety of Tazobactam/ceftolozane in Japanese Patients With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection." Journal of Infection and Chemotherapy : Official Journal of the Japan Society of Chemotherapy, vol. 25, no. 2, 2019, pp. 104-110.
Arakawa S, Kawahara K, Kawahara M, et al. The efficacy and safety of tazobactam/ceftolozane in Japanese patients with uncomplicated pyelonephritis and complicated urinary tract infection. J Infect Chemother. 2019;25(2):104-110.
Arakawa, S., Kawahara, K., Kawahara, M., Yasuda, M., Fujimoto, G., Sato, A., Yokokawa, R., Yoshinari, T., Rhee, E. G., & Aoyama, N. (2019). The efficacy and safety of tazobactam/ceftolozane in Japanese patients with uncomplicated pyelonephritis and complicated urinary tract infection. Journal of Infection and Chemotherapy : Official Journal of the Japan Society of Chemotherapy, 25(2), 104-110. https://doi.org/10.1016/j.jiac.2018.10.009
Arakawa S, et al. The Efficacy and Safety of Tazobactam/ceftolozane in Japanese Patients With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection. J Infect Chemother. 2019;25(2):104-110. PubMed PMID: 30420153.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The efficacy and safety of tazobactam/ceftolozane in Japanese patients with uncomplicated pyelonephritis and complicated urinary tract infection. AU - Arakawa,Soichi, AU - Kawahara,Kazuya, AU - Kawahara,Motoshi, AU - Yasuda,Mitsuru, AU - Fujimoto,Go, AU - Sato,Asako, AU - Yokokawa,Ruriko, AU - Yoshinari,Tomoko, AU - Rhee,Elizabeth G, AU - Aoyama,Norihiro, Y1 - 2018/11/09/ PY - 2018/08/24/received PY - 2018/10/05/revised PY - 2018/10/15/accepted PY - 2018/11/14/pubmed PY - 2019/3/26/medline PY - 2018/11/14/entrez KW - Bacterial count KW - Ceftolozane KW - ESBL KW - Japanese patient KW - Pyelonephritis KW - Urinary tract infection SP - 104 EP - 110 JF - Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy JO - J Infect Chemother VL - 25 IS - 2 N2 - We report efficacy and safety results for a combination of a novel cephalosporin class antibiotic and a β-Lactamase inhibitor, tazobactam/ceftolozane (1:2) at a dose of 1.5 g intravenously every 8 h in Japanese patients with uncomplicated pyelonephritis and complicated urinary tract infection. This study design was a nonrandomized, multicenter, open-label trial, and the treatment period was 7 days. Of 115 patients enrolled in this study, 114 received tazobactam/ceftolozane, and 90 were included in the efficacy analyses. Ninety-nine isolates (bacterial count ≥105 CFU/mL) were identified by urine culture. The main baseline uropathogens were Escherichia coli (80 isolates), Klebsiella pneumoniae (8 isolates), and Proteus mirabilis (3 isolates). Of these, 13 isolates were ESBL-producers. The favorable per-patient microbiological response rate at 7 days after the final administration of tazobactam/ceftolozane was 80.7% (71/88). The response rate in uncomplicated pyelonephritis was 90.0% (36/40), complicated pyelonephritis 63.6% (14/22), and complicated cystitis 80.8% (21/26). The favorable clinical response rate was 96.6% (86/89), and composite response rate (based on microbiological and clinical response) was 80.7% (71/88). The eradication rate by uropathogen was 83.5% (66/79) in E. coli, 42.9% (3/7) in K. pneumoniae, and 100% (3/3) in P. mirabilis. The incidence of drug-related adverse events was 17.5% (20/114 patients). The most common drug-related adverse events were diarrhea and alanine aminotransferase increased in 5.3% (6/114 patients each). Drug-related serious adverse events and deaths were not observed. These results support the safety and efficacy of tazobactam/ceftolozane and suggest it will be a useful treatment for uncomplicated pyelonephritis and complicated urinary tract infection. SN - 1437-7780 UR - https://www.unboundmedicine.com/medline/citation/30420153/The_efficacy_and_safety_of_tazobactam/ceftolozane_in_Japanese_patients_with_uncomplicated_pyelonephritis_and_complicated_urinary_tract_infection_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1341-321X(18)30416-1 DB - PRIME DP - Unbound Medicine ER -