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Clinical Study on the Pharmacokinetics of Cefiderocol in Blood and Tissues in Patients Undergoing Lower Gastrointestinal Surgery

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Requiring elective surgery of the lower gastrointestinal tract (ileum, colon, rectum, or anus)
Date of first enrollment	04/11/2025
Target sample size	10
Countries of recruitment
Study type	Interventional
Intervention(s)	<Drug Administration> Cefiderocol (CFDC) will be used as a prophylactic antibiotic. Metronidazole 500 mg will be co-administered. In cases where the surgery exceeds 3 hours, cefmetazole (CMZ) will be additionally administered 3 hours after the start of surgery. For patients with normal renal function:CFDC 2 g will be administered over 3 hours prior to the start of surgery. For patients with impaired renal function: For patients with creatinine clearance (Ccr) between 30 and <60 mL/min: CFDC 1.5 g will be administered over 3 hours prior to the start of surgery.

Outcome(s)

Primary Outcome	The drug concentrations in blood, ascitic fluid, and tissues (subcutaneous adipose tissue and peritoneum), along with the derived pharmacokinetic (PK) parameters such as Cmax, AUC, T1/2, and Tmax, as well as the time above the minimum inhibitory concentration (T > MIC).
Secondary Outcome	None

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Hospitalized patients aged 18 years or older scheduled for elective lower gastrointestinal surgery, with no restriction on sex, who have given their written informed consent to participate in this study will be enrolled.
Exclude criteria	Patients with a history of allergy to cefiderocol (CFDC). Patients with a history of allergy to beta-lactam antibiotics. Patients with a history of seizures or with central nervous system disorders. Patients with renal impairment, defined as a creatinine clearance of less than 30 mL/min as estimated by the Cockcloft-Gault formula. Women who are pregnant, may be pregnant, or are breastfeeding. Patients who are currently participating in another clinical trial or interventional clinical study (excluding observational studies), or who intend to participate in another such trial or study during the study period. Patients who are judged by the principal investigator or a co-investigator to be likely to suffer undue disadvantage by participating in the study. Patients who are judged by the principal investigator or a co-investigator to make the conduct or evaluation of the study difficult.