Requiring elective surgery of the lower gastrointestinal tract (ileum, colon, rectum, or anus) Colorectal cancer,Ulcerative colitis,Crohn's disease
Conditions
Interventions
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 administe
Sponsors
Ohge Hiroki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Contacts
Public ContactKensuke Shimbara
Hiroshima University
Outcome results
None listed