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

JRCT ID: jRCTs061230082

Registered date:21/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diseases that are eligible for standby lower gastrointestinal (ileum, colon, rectum, anus) surgery.
• Date of first enrollment: 07/02/2024
• Target sample size: 40
• Study type: Interventional

Intervention(s)

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, metronidazole (MNZ) is used in combination.
3. The usual single dose of antimicrobial agents (MEPM, TAZ/PIPC, TAZ/CTLZ+MNZ, CFPM+MNZ) should be administered before the start of surgery, followed immediately by continuous administration of the single dose at the dosing interval time specified in the package insert for each antimicrobial agent. Antimicrobial agents should be administered up to 6 hours after the start of surgery.

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Ohge Hiroki