Diverticulosis, ColonicPhase 4NCT00535652
Concentration of Ertapenem in Colorectal Tissue
A Phase 4 study testing Ertapenem in people with Diverticulosis, Colonic and Rectal Neoplasms, run by University of Ulm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diverticulosis, Colonic, Rectal Neoplasms, Colonic Neoplasms
- What is being tested?
- Ertapenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Dec 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Konzentrationen Von Ertapenem in Kolorektalem Gewebe
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.
Read the detailed description
The purpose of this study is to determine the tissue kinetics of ertapenem in colorectal tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem before an elective surgical intervention (open or laparoscopic surgery) at the colon/rectum. Subjects are patients. Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at the colon will be eligible for this study.
- Conditions
- Diverticulosis, Colonic, Rectal Neoplasms, Colonic Neoplasms
- Being tested
- Ertapenem
- Medical subject headings
- Diverticulosis, Colonic, Rectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErtapenemDrug
Also called Invanz, EU/1/02/216/001 + /002, ATC code: J01DH03
powder for infusion, 1 gram I.V., single dose over 30 min.
| Study group | Role | What they receive |
|---|---|---|
| Ertapenem | Experimental | Administration of 1 gram ertapenem I.V. Receives: Drug: Ertapenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..
Measured: 3 to 6 hours after a single dose of 1 gram ertapenem I.V..
Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue
The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours
Measured: The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours
Secondary outcomes (1)
Safety Assessment
Measured: 0 to approx. 14 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diverticulosis, ColonicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Wittau, University of Ulm
- Investigators
- Doris Henne-Bruns, Prof. Dr., Principal investigator, University of Ulm, Dept. of Visceral Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535652
- Sponsor's protocol ID
- 01-07
- Status last verified
- Dec 2016
- First submitted
- 24 Sep 2007
- Last updated
- 10 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wittau 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.
PubMed 22189340
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Konzentrationen Von Ertapenem in Kolorektalem Gewebe
- ClinicalTrials.gov ID
- NCT00535652
- Acronym / sponsor ID
- 01-07
- Conditions
- Diverticulosis, Colonic, Rectal Neoplasms, Colonic Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Posted 16 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to determine the tissue kinetics of ertapenem in colorectal tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem before an elective surgical intervention (open or laparoscopic surgery) at the colon/rectum. Subjects are patients. Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at the colon will be eligible for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ertapenem | Experimental | Drug: ErtapenemAdministration of 1 gram ertapenem I.V. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErtapenemAlso: Invanz, EU/1/02/216/001 + /002, ATC code: J01DH03powder for infusion, 1 gram I.V., single dose over 30 min. | Drug | Ertapenem |
Primary outcome
Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..
Time frame: 3 to 6 hours after a single dose of 1 gram ertapenem I.V..
Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue
Time frame: The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours
The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours
1 secondary outcome
Safety Assessment
Time frame: 0 to approx. 14 days after admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22189340Wittau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris Henne-Bruns, Prof. Dr. principal investigator
University of Ulm, Dept. of Visceral Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ertapenem in people with Diverticulosis, Colonic and Rectal Neoplasms, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V.. (time frame: 3 to 6 hours after a single dose of 1 gram ertapenem I.V..). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00535652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.