Clinical trial · Interventional
Concentration of Ertapenem in Colorectal Tissue
Konzentrationen Von Ertapenem in Kolorektalem Gewebe
NCT00535652CI-TRIAL-00025926completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Diverticulosis, Colonic | — | UNRESOLVED | — |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ertapenem | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ertapenem
- description
- Administration of 1 gram ertapenem I.V.
- interventionNames
- Drug: Ertapenem
Primary outcomes (2)
- measure
- Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..
- timeFrame
- 3 to 6 hours after a single dose of 1 gram ertapenem I.V..
- measure
- Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue
- timeFrame
- The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours
- description
- The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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 \< 1000 cells/mm3, platelets \< 75000 cells/mm3 and coagulation studies (INR) \> 1.5 x ULN, ongoing therapy with valproin acid.
References
Publications (1)
- DERIVEDWittau M, Scheele J, Bulitta JB, Mayer B, Kaever V, Burhenne H, Henne-Bruns D, Isenmann R, Brockschmidt C. Pharmacokinetics of ertapenem in colorectal tissue. Chemotherapy. 2011;57(5):437-48. doi: 10.1159/000333377. Epub 2011 Dec 22. PMID 22189340