Study on Pharmacokinetic Dynamics in Blood and Tissues of Continuous Administration of Beta-Lactam Antimicrobial Agents

Exploratory Clinical Study on Pharmacokinetic Dynamics in Blood and Tissues of Continuous Administration of Beta-Lactam Antimicrobial Agents to Patients undergoing Lower Gastrointestinal Tract Surgery

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061230082

Enrollment

Registered

2023-12-21

Start date

2024-02-07

Completion date

Unknown

Last updated

2025-07-18

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

Conditions

Diseases that are eligible for standby lower gastrointestinal (ileum, colon, rectum, anus) surgery.

Interventions

1. Meropenem (MEPM), Tazobactam/Piperacillin (TAZ/PIPC), Tazobactam/Ceftolozane (TAZ/CTLZ), or Cefepime (CFPM) is used as a prophylactic antimicrobial agent. 2. In the TAZ/CTLZ and CFPM groups, metron

beta-lactam antibiotics

continuous infusion

tissue concentrations

blood concentrations

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Standby surgical patients for the lower gastrointestinal tract (whether open or laparoscopic surgery) 2. Patients over 18 years old 3. Patients who give their written consent to participate in this study

Exclusion criteria

Exclusion criteria: 1. Patients with a history of allergy to meropenem, tazobactam piperacillin, tazobactam ceftarosan, cefepime, or metronidazole 2. Patients with a history of allergy to beta-lactam antibacterial agents 3. Patients with impaired renal function whose creatinine clearance estimated by the Cockloft-Gault equation is less than 30 ml/min 4. Patients who are participating or intend to participate in other clinical studies while participating in this study 5. Patients currently using sodium valproate 6. Pregnant or lactating patients 7. Patients who are judged by the principal investigator or subinvestigator to be unjustly disadvantaged by participating in the study. 8. Patients whose participation in the research is judged by the principal investigator or subinvestigator to cause difficulty in conducting or evaluating this clinical research. 9. Employees of the Principal Investigators, etc., or of the institution who are directly involved in this or other clinical research, or family members of such employees or Principal Investigators, etc.

Design outcomes

Primary

Measure	Time 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 ContactHiroki Kitagawa

Hiroshima University

hkitaga@hiroshima-u.ac.jp+81-822571613

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026