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

Phase 1
Recruiting
Conditions
Diseases that are eligible for standby lower gastrointestinal (ileum, colon, rectum, anus) surgery.
Registration Number
JPRN-jRCTs061230082
Lead Sponsor
Ohge Hiroki
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
40
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pharmacokinetic parameters (Cmax, AUC, T1/2, Tmax) of each drug in plasma, peritoneal fluid and abdominal tissues (peritoneum and subcutaneous adipose tissue)
Secondary Outcome Measures
NameTimeMethod
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