Infections During Organ Replacement TherapyPhase 3NCT02018939
Multiple-dose Pharmacokinetics of Doripenem During Continuous Venovenous Hemodiafiltration and Molecular Adsorbent Recirculating System in ICU Patients and During Hemodialysis in Longterm Hemodialysis Patients.
A Phase 3 study testing Pharmacokinetic profiling in people with Infections During Organ Replacement Therapy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The study is conducted to investigate the pharmacokinetics of Doripenem during CVVHDF (Continuous venovenous hemodiafiltration), MARS (Molecular Adsorbent Recirculating System) and intermittent hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections During Organ Replacement Therapy
- What is being tested?
- Pharmacokinetic profiling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2010to Feb 2014
- Phase
- Phase 3
- 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
- Age >18 years
- Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
- Organ replacement therapy (MARS, CVVHDF or HD)
Who cannot join
- Known hypersensitivity to doripenem or other carbapenems, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
- An expected survival of less than two days.
- Known pregnancy
- Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study
- Doripenem as monotherapy for resistent species or fungal infections.
- Other reasons opposing the study participation on the discretion of the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
The study is conducted to investigate the pharmacokinetics of Doripenem during CVVHDF (Continuous venovenous hemodiafiltration), MARS (Molecular Adsorbent Recirculating System) and intermittent hemodialysis.
- Being tested
- Pharmacokinetic profiling
- Keywords
- pharmacokinetics, doripenem, renal replacement therapy, MARS, organ replacement therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetic profilingOther
Pharmacokinetic samples are taken from each Patient receiving Doripenem in each arm. No other interventions are performed during this trial. Doripenem is not administered due to the trial.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetic profiling in Hemodialysis | Experimental | Patients with chronic intermittent hemodialysis receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn. Receives: Other: Pharmacokinetic profiling |
| Pharmacokinetic profiling in CVVH | Experimental | Patients receiving continuous venovenous renal replacement therapy in an ICU setting receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn. Receives: Other: Pharmacokinetic profiling |
| Pharmacokinetic profiling in MARS | Experimental | Patients receiving liver replacement therapy (MARS) in an ICU setting receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn. Receives: Other: Pharmacokinetic profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of organ replacement therapy on area under curve of doripenem serum concentration
Pharmacokinetic samples are drawn from each patient during the trial. Analysis by HPLC will be conducted after the end of the trial.
Measured: day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startMar 2010
- Primary completionFeb 2014
- Study completionFeb 2014
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 Infections During Organ Replacement TherapyStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florian Thalhammer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018939
- Sponsor's protocol ID
- DORIPENEM IN CVVH, MARS AND HD
- Status last verified
- Mar 2014
- First submitted
- 16 Oct 2013
- Last updated
- 28 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vossen MG, Ehmann L, Pferschy S, Maier-Salamon A, Haidinger M, Weiser C, Wenisch JM, Saria K, Kajahn C, Jilch S, Lemmerer R, Becede M, Zeitlinger M, Kloft C, Jager W, Thalhammer F. Elimination of Doripenem during Dialysis and Pharmacokinetic Evaluation of Posthemodialysis Dosing for Patients Undergoing Intermittent Renal Replacement Therapy. Antimicrob Agents Chemother. 2018 Apr 26;62(5):e02430-17. doi: 10.1128/AAC.02430-17. Print 2018 May.
PubMed 29530855Vossen MG, Wenisch JM, Maier-Salamon A, Fritsch A, Saria K, Zuba C, Jilch S, Lemmerer R, Unger M, Jaehde U, Jager W, Thalhammer F. Doripenem Treatment during Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2015 Dec 28;60(3):1687-94. doi: 10.1128/AAC.01801-15.
PubMed 26711775
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-dose Pharmacokinetics of Doripenem During Continuous Venovenous Hemodiafiltration and Molecular Adsorbent Recirculating System in ICU Patients and During Hemodialysis in Longterm Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT02018939
- Acronym / sponsor ID
- DORIPENEM IN CVVH, MARS AND HD
- Keywords
- pharmacokinetics, doripenem, renal replacement therapy, MARS, organ replacement therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 23 Dec 2013 (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 study is conducted to investigate the pharmacokinetics of Doripenem during CVVHDF (Continuous venovenous hemodiafiltration), MARS (Molecular Adsorbent Recirculating System) and intermittent hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetic profiling in Hemodialysis | Experimental | Other: Pharmacokinetic profilingPatients with chronic intermittent hemodialysis receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn. |
| Pharmacokinetic profiling in CVVH | Experimental | Other: Pharmacokinetic profilingPatients receiving continuous venovenous renal replacement therapy in an ICU setting receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn. |
| Pharmacokinetic profiling in MARS | Experimental | Other: Pharmacokinetic profilingPatients receiving liver replacement therapy (MARS) in an ICU setting receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
- Organ replacement therapy (MARS, CVVHDF or HD)
Key exclusion criteria (6 listed)
- Known hypersensitivity to doripenem or other carbapenems, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
- An expected survival of less than two days.
- Known pregnancy
- Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study
- Doripenem as monotherapy for resistent species or fungal infections.
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 |
|---|---|---|
| Pharmacokinetic profilingPharmacokinetic samples are taken from each Patient receiving Doripenem in each arm. No other interventions are performed during this trial. Doripenem is not administered due to the trial. | Other | Pharmacokinetic profiling in CVVH, Pharmacokinetic profiling in Hemodialysis, Pharmacokinetic profiling in MARS |
Primary outcome
Influence of organ replacement therapy on area under curve of doripenem serum concentration
Time frame: day 15
Pharmacokinetic samples are drawn from each patient during the trial. Analysis by HPLC will be conducted after the end of the trial.
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 28 Mar 2014.
- Derived from this study: PubMed 29530855Vossen MG, Ehmann L, Pferschy S, Maier-Salamon A, Haidinger M, Weiser C, Wenisch JM, Saria K, Kajahn C, Jilch S, Lemmerer R, Becede M, Zeitlinger M, Kloft C, Jager W, Thalhammer F. Elimination of Doripenem during Dialysis and Pharmacokinetic Evaluation of Posthemodialysis Dosing for Patients Undergoing Intermittent Renal Replacement Therapy. Antimicrob Agents Chemother. 2018 Apr 26;62(5):e02430-17. doi: 10.1128/AAC.02430-17. Print 2018 May.
- Derived from this study: PubMed 26711775Vossen MG, Wenisch JM, Maier-Salamon A, Fritsch A, Saria K, Zuba C, Jilch S, Lemmerer R, Unger M, Jaehde U, Jager W, Thalhammer F. Doripenem Treatment during Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2015 Dec 28;60(3):1687-94. doi: 10.1128/AAC.01801-15.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pharmacokinetic profiling in people with Infections During Organ Replacement Therapy, 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 3 inclusion and 6 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 28 Mar 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Influence of organ replacement therapy on area under curve of doripenem serum concentration (time frame: day 15). 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 NCT02018939, 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 28 Mar 2014.