ObesityPhase 4NCT01407965
Pharmacokinetics of Carbapenem Antibiotics in Obese Patients.
A Phase 4 study testing microdialysis catheter in people with Obesity, run by University of Ulm at 2 sites in Germany.
Trial summary
Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and plasma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- microdialysis catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2012to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- 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 intraabdominal organs
- BMI more or even 40
- written informed consent
Who cannot join
- BMI < 40
- pregnancy or lactation in women
- emergency surgery
- history of serious allergy or intolerance to β-lactam antibiotics
- 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
Show all 14Show fewer
- terminal illness
- 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
- coagulation studies (INR) > 1.5 x ULN
- ongoing chemotherapy and/or radiotherapy
- ongoing therapy with valproin acid (in case of ertapenem administration).
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University of Ulm, Dept. of Visceral Surgery
Ulm, 89075
University of Ulm
Ulm, 89075
About this study
Official title: Offene, Monozentrische, Nicht Kontrollierte Und Nicht Randomisierte Phase IV-Studie Zur Bestimmung Der Pharmakokinetik Von Carbapenemen in adipösen Patienten.
Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and plasma.
Read the detailed description
The purpose of this study is to determine the free tissue kinetics of ertapenem and meropenem in fatty tissue and intraperitoneal fluid up to 24 hours after administration of the IMP.
- Conditions
- Obesity
- Being tested
- microdialysis catheter
- Keywords
- obesity, pharmacokinetic, ertapenem, meropenem
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microdialysis catheterProcedure or surgery
Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity
microdialysis catheterProcedure or surgery
Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity
| Study group | Role | What they receive |
|---|---|---|
| Ertapenem | Experimental | Free tissue kinetics of ertapenem in fatty tissue and intraperitoneal fluid in mg/L
Free and bound plasma concentration of ertapenem or meropenem in mg/L Receives: Procedure: microdialysis catheter |
| Meropenem | Experimental | Free tissue kinetics of meropenem in fatty tissue and intraperitoneal fluid in mg/L up to 24 hours after administration. Free and bound plasma concentration of meropenem in mg/L. Receives: Procedure: microdialysis catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid
Measured: within 24 h after administration
Secondary outcomes (3)
Number of Adverse Events (total and per patient)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Number of Serious Adverse Events (total and per patient)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Number of Suspected Unexpected Serious Adverse Reactions (SUSARs)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startApr 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 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, PhD, Principal investigator, University of UlmMathias Wittau, Dr., Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407965
- Sponsor's protocol ID
- Adip-2010
- Other IDs
- 2010-024094-39
- Status last verified
- Oct 2016
- First submitted
- 26 Jul 2011
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wittau M, Paschke S, Kurlbaum M, Scheele J, Ly NS, Hemper E, Kornmann M, Henne-Bruns D, Bulitta JB. Population Pharmacokinetics and Target Attainment of Ertapenem in Plasma and Tissue Assessed via Microdialysis in Morbidly Obese Patients after Laparoscopic Visceral Surgery. Antimicrob Agents Chemother. 2016 Dec 27;61(1):e00952-16. doi: 10.1128/AAC.00952-16. Print 2017 Jan.
PubMed 27795367Wittau M, Scheele J, Kurlbaum M, Brockschmidt C, Wolf AM, Hemper E, Henne-Bruns D, Bulitta JB. Population Pharmacokinetics and Target Attainment of Meropenem in Plasma and Tissue of Morbidly Obese Patients after Laparoscopic Intraperitoneal Surgery. Antimicrob Agents Chemother. 2015 Oct;59(10):6241-7. doi: 10.1128/AAC.00259-15. Epub 2015 Jul 27.
PubMed 26248353
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Offene, Monozentrische, Nicht Kontrollierte Und Nicht Randomisierte Phase IV-Studie Zur Bestimmung Der Pharmakokinetik Von Carbapenemen in adipösen Patienten.
- ClinicalTrials.gov ID
- NCT01407965
- Acronym / sponsor ID
- Adip-2010
- Conditions
- Obesity
- Keywords
- obesity, pharmacokinetic, ertapenem, meropenem
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and plasma.
Detailed description
The purpose of this study is to determine the free tissue kinetics of ertapenem and meropenem in fatty tissue and intraperitoneal fluid up to 24 hours after administration of the IMP.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ertapenem | Experimental | Procedure: microdialysis catheterFree tissue kinetics of ertapenem in fatty tissue and intraperitoneal fluid in mg/L Free and bound plasma concentration of ertapenem or meropenem in mg/L |
| Meropenem | Experimental | Procedure: microdialysis catheterFree tissue kinetics of meropenem in fatty tissue and intraperitoneal fluid in mg/L up to 24 hours after administration. Free and bound plasma concentration of meropenem in mg/L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at intraabdominal organs
- BMI more or even 40
- written informed consent
Key exclusion criteria (14 listed)
- BMI < 40
- pregnancy or lactation in women
- emergency surgery
- history of serious allergy or intolerance to β-lactam antibiotics
- systemic antimicrobial therapy with ceftazidime (internal standard of high-performance liquid chromatography / mass spectrometry) within a 7 days period prior to study entry
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 |
|---|---|---|
| microdialysis catheterPlacing of microdialysis catheter in fatty tissue and in the peritoneal cavity | Procedure or surgery | Ertapenem |
| microdialysis catheterPlacing of microdialysis catheter in fatty tissue and in the peritoneal cavity | Procedure or surgery | Meropenem |
Primary outcome
Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid
Time frame: within 24 h after administration
3 secondary outcomes
Number of Adverse Events (total and per patient)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Number of Serious Adverse Events (total and per patient)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Number of Suspected Unexpected Serious Adverse Reactions (SUSARs)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Derived from this study: PubMed 27795367Wittau M, Paschke S, Kurlbaum M, Scheele J, Ly NS, Hemper E, Kornmann M, Henne-Bruns D, Bulitta JB. Population Pharmacokinetics and Target Attainment of Ertapenem in Plasma and Tissue Assessed via Microdialysis in Morbidly Obese Patients after Laparoscopic Visceral Surgery. Antimicrob Agents Chemother. 2016 Dec 27;61(1):e00952-16. doi: 10.1128/AAC.00952-16. Print 2017 Jan.
- Derived from this study: PubMed 26248353Wittau M, Scheele J, Kurlbaum M, Brockschmidt C, Wolf AM, Hemper E, Henne-Bruns D, Bulitta JB. Population Pharmacokinetics and Target Attainment of Meropenem in Plasma and Tissue of Morbidly Obese Patients after Laparoscopic Intraperitoneal Surgery. Antimicrob Agents Chemother. 2015 Oct;59(10):6241-7. doi: 10.1128/AAC.00259-15. Epub 2015 Jul 27.
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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, PhD principal investigator
University of Ulm
Mathias Wittau, Dr. principal investigator
University of Ulm
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing microdialysis catheter in people with Obesity, run by University of Ulm at 2 sites 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 3 inclusion and 14 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 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid (time frame: within 24 h after administration). 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 NCT01407965, which also lists 2 linked publications.
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 17 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.