Phase 4
Completed N=23
Concentration of Ertapenem in Colorectal Tissue
Diverticulosis, Colonic · rectal neoplasms · Colonic Neoplasms
Source: ClinicalTrials.gov NCT00535652 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..
◆ Published Evidence
Emerging
8citations · ~1 / year
Pharmacokinetics of ertapenem in colorectal tissue.
Summary
The purpose of this study is to determine the tissue kinetics of ertapenem in colonic tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem.
Linked Publications
-
Pharmacokinetics of ertapenem in colorectal tissue.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V.. |
— | — |
| PRIMARY Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue |
6.4 | — |
| SECONDARY Safety Assessment |
— | — |
Eligibility Criteria
Inclusion Criteria
- Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at the colon will be eligible for this study.
- Patients with benignant disorders (e.g. colonic diverticulosis) will be preferred.
Exclusion Criteria
- Pregnancy or lactation in women
- Emergency surgery, history of serious allergy or intolerance to β-lactam antibiotics and other carbapenems
- Systemic antimicrobial therapy with ceftazidime (internal standard of high-performance liquid chromatography / mass spectrometry) within a 7 days period prior to study entry
- Ongoing intraabdominal infections
- Terminal illness
- Chronic immunosuppressive therapy
- Severe diseases of the liver, e.g. cirrhosis of the liver with ALT or AST > 6 x upper limit of normal (ULN) and bilirubin > 3 x ULN, severe renal insufficiency with a creatinine clearance ≤30 mL/min., neutrophil count 1.5 x ULN, ongoing therapy with valproin acid.
Data sourced from ClinicalTrials.gov (NCT00535652) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.