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Study on pharmacokinetics of prophylactic antibiotics for surgical site infection by ESBL-producing Escherichia coli after lower gastrointestinal surgery

Exploratory study on pharmacokinetics and optimum dosing regimen of cefmetazole, flomoxef and ceftolozane-tazobactam as prophylaxis for surgical site infection by ESBL-producing Escherichia coli after lower gastrointestinal surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061190025
Enrollment
30
Registered
2019-12-18
Start date
2020-01-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lower gastrointestinal disease with surgical indication (regardless of benign or malignant) lower gastrointestinal infection, intra-abdominal infection

Interventions

Cefmetazole, flomoxef or ceftolozane-tazobactam + metronidazole is administered intravenously as a prophylactic antibiotics for elective lower gastrointestinal surgery. Each drug is administered just
lower gastrointestinal surgery, intra-abdominal infection, cefmetazole, flomoxef, ceftolozane-tazobactam, metronidazole

Sponsors

Ohge Hiroki
Lead Sponsor
Yoshimura Kosuke
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Patients scheduled for elective lower gastrointestinal surgery (regardless of open surgery or laparoscopic surgery) gastrointestinal surgery (limited to open surgery cases) 2 Inpatients over 20 years old (include 20 years old) who agree to participate in this study, regardless of gender 3 Patients who can give written informed consent to participate in this study

Exclusion criteria

Exclusion criteria: 1 Patients with a history of allergies to Cefmetazole, Flomoxef, Ceftolozane/Tazobactam or Metronidazole 2 Patients with a history of allergies to cephems 3 Combined use of 4 Patients who are pregnant or nursing 5 Patients with organic diseases in the brain and spinal cord 6 Patients with renal dysfunction who have creatinine clearance less than 50 ml / min estimated by Cockloft-Gault equation 7 Patients judged inappropriate for this study by the researcher

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameters (Cmax, AUC, T1/2, Tmax) of each drug in plasma, peritoneal fluid and abdominal tissues (peritoneum and subcutaneous adipose tissue)

Contacts

Public ContactKosuke Yoshimura

Hiroshima University graduate school

y1986@hiroshima-u.ac.jp+81-82-257-5216

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026