PneumoniaNCT01414959
Target Site Pharmacokinetics of Doripenem at Steady State in Intubated Intensive Care Patients
An observational study of Pneumonia and Abdominal Infection, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The investigators will measure the pharmacokinetics of doripenem in skeletal muscle, subcutaneous adipose tissue, bronchoalveolar lavage and plasma of intubated intensive care patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Abdominal Infection, Urinary Tract Infection
- How many people
- 16 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2011to Jul 2013
- Phase
- Observational
- 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
Study population: intubated patients, intensive care
Who may be able to join
- endotracheal intubation; pneumonia or complicated abdominal infection or complicated urinary tract infection
Who cannot join
- allergy to doripenem, hemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will measure the pharmacokinetics of doripenem in skeletal muscle, subcutaneous adipose tissue, bronchoalveolar lavage and plasma of intubated intensive care patients.
Read the detailed description
Methods: microdialysis, blood sampling, bronchoalveolar lavage
- Conditions
- Pneumonia, Abdominal Infection, Urinary Tract Infection
- Keywords
- intensive care patient, intubation, (please change wording as you like!)
- Medical subject headings
- Pneumonia, Intraabdominal Infections, Urinary Tract Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Zeitlinger, Medical University of Vienna
- Investigators
- Markus Zeitlinger, MD, Principal investigator, Medical Universit of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414959
- Sponsor's protocol ID
- Dori_MD_ICU
- Status last verified
- Aug 2017
- First submitted
- 10 Aug 2011
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Site Pharmacokinetics of Doripenem at Steady State in Intubated Intensive Care Patients
- ClinicalTrials.gov ID
- NCT01414959
- Acronym / sponsor ID
- Dori_MD_ICU
- Conditions
- Pneumonia, Abdominal Infection, Urinary Tract Infection
- Keywords
- intensive care patient, intubation, (please change wording as you like!)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 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.
The investigators will measure the pharmacokinetics of doripenem in skeletal muscle, subcutaneous adipose tissue, bronchoalveolar lavage and plasma of intubated intensive care patients.
Detailed description
Methods: microdialysis, blood sampling, bronchoalveolar lavage
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- intubated patients, intensive care
Key inclusion criteria (1 listed)
- endotracheal intubation; pneumonia or complicated abdominal infection or complicated urinary tract infection
Key exclusion criteria (1 listed)
- allergy to doripenem, hemodialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 29 Aug 2017.
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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.
Markus Zeitlinger, MD principal investigator
Medical Universit of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Abdominal Infection, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 1 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 29 Aug 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 Austria. 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.
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.
Where can I read the original study information?
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 29 Aug 2017.