Phase 4
N=23
Concentration of Ertapenem in Colorectal Tissue
Diverticulosis, Colonic · Rectal Neoplasms · Colonic Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00535652 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ertapenem (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Ulm
- Primary completion
- Dec 2009
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 |
— | — |
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.
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). 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.