AntibioticsMSBVNCT03335137
Determining Drug Levels of Beta-lactam Antibiotics in Severe Burned Patients
An observational study of Antibiotics and Severe Burn, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
At antibiotic stewardship of the University Hospital of Schleswig-Holsten it was noticed that there are much less studies measuring drug levels in severe burned patients than are required. Especially, severe burned patient developing a capillary leak might show lower drug levels than patients without a capillary leak. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotics, Severe Burn, Intensive Care
- What is being tested?
- Drug Level Monitoring
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2014to 31 Dec 2016
- 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: Patients treated on ICU, in group 1 suffering from severe burns, in group 2 without burns
Who may be able to join
- General
- Adult
- Receiving beta-lactam antibiotic Piperacillin/Tazobactam
- Antibiotic therapy of 3 or more days
- Given informed consent Group 1
- Severe Burn Group 2
- No Severe Burn
Who cannot join
- Already in another Study
- No useful blood sample
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
About this study
At antibiotic stewardship of the University Hospital of Schleswig-Holsten it was noticed that there are much less studies measuring drug levels in severe burned patients than are required. Especially, severe burned patient developing a capillary leak might show lower drug levels than patients without a capillary leak. To compare drug levels of beta-lactam antibiotics, it is the aim of this study to measure pharmacokinetics of Piperacillin/Tazobactam in ICU patients with and without severe burns.
- Conditions
- Antibiotics, Severe Burn, Intensive Care
- Being tested
- Drug Level Monitoring
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Level MonitoringDiagnostic test
Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission
| Study group | Role | What they receive |
|---|---|---|
| ICU Patients with Severe Burns | Patients suffering from severe burns treated on a burn unit - Drug Level Monitoring Piperacillin/Tazobactam Receives: Diagnostic Test: Drug Level Monitoring | |
| ICU Patients without Burns - Drug Level Monitoring | Patient suffering from disease treated on an ICU - Drug Level Monitoring Piperacillin/Tazobactam Receives: Diagnostic Test: Drug Level Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission
Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission
Measured: 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start1 May 2014
- Primary completion31 May 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AntibioticsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Clinic III, Dezernat Apotheke
- Responsible party
- Principal investigator, Tobias Kisch, University Hospital Schleswig-Holstein
- Investigators
- Peter Mailänder, PhD, Study director, Plastic and Reconstructive Surgery, Hand Surgery, Burn UnitWalter Raasch, PhD, Study chair, Institute for experimental and clinical pharmacology and toxicologyTobias Kisch, MD, Principal investigator, Plastic and Reconstructive Surgery, Hand Surgery, Burn Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335137
- Sponsor's protocol ID
- 13-275
- Acronym
- MSBV
- Status last verified
- Nov 2017
- First submitted
- 24 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rafla K, Tredget EE. Infection control in the burn unit. Burns. 2011 Feb;37(1):5-15. doi: 10.1016/j.burns.2009.06.198. Epub 2010 Jun 18.
PubMed 20561750Roberts JA. Using PK/PD to optimize antibiotic dosing for critically ill patients. Curr Pharm Biotechnol. 2011 Dec;12(12):2070-9. doi: 10.2174/138920111798808329.
PubMed 21554211Blanchet B, Jullien V, Vinsonneau C, Tod M. Influence of burns on pharmacokinetics and pharmacodynamics of drugs used in the care of burn patients. Clin Pharmacokinet. 2008;47(10):635-54. doi: 10.2165/00003088-200847100-00002.
PubMed 18783295Patel BM, Paratz J, See NC, Muller MJ, Rudd M, Paterson D, Briscoe SE, Ungerer J, McWhinney BC, Lipman J, Roberts JA. Therapeutic drug monitoring of beta-lactam antibiotics in burns patients--a one-year prospective study. Ther Drug Monit. 2012 Apr;34(2):160-4. doi: 10.1097/FTD.0b013e31824981a6.
PubMed 22406650Olbrisch K, Kisch T, Thern J, Kramme E, Rupp J, Graf T, Wicha SG, Mailander P, Raasch W. After standard dosage of piperacillin plasma concentrations of drug are subtherapeutic in burn patients. Naunyn Schmiedebergs Arch Pharmacol. 2019 Feb;392(2):229-241. doi: 10.1007/s00210-018-1573-6. Epub 2018 Oct 27.
PubMed 30368548
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Drug Levels of Beta-lactam Antibiotics in Severe Burned Patients
- ClinicalTrials.gov ID
- NCT03335137
- Acronym / sponsor ID
- MSBV / 13-275
- Conditions
- Antibiotics, Severe Burn, Intensive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- Medical Clinic III, Dezernat Apotheke
- Study start
- 1 May 2014 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 7 Nov 2017 (actual)
- 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.
At antibiotic stewardship of the University Hospital of Schleswig-Holsten it was noticed that there are much less studies measuring drug levels in severe burned patients than are required. Especially, severe burned patient developing a capillary leak might show lower drug levels than patients without a capillary leak. To compare drug levels of beta-lactam antibiotics, it is the aim of this study to measure pharmacokinetics of Piperacillin/Tazobactam in ICU patients with and without severe burns.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU Patients with Severe Burns | – | Diagnostic Test: Drug Level MonitoringPatients suffering from severe burns treated on a burn unit - Drug Level Monitoring Piperacillin/Tazobactam |
| ICU Patients without Burns - Drug Level Monitoring | – | Diagnostic Test: Drug Level MonitoringPatient suffering from disease treated on an ICU - Drug Level Monitoring Piperacillin/Tazobactam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated on ICU, in group 1 suffering from severe burns, in group 2 without burns
Key inclusion criteria (7 listed)
- General
- Adult
- Receiving beta-lactam antibiotic Piperacillin/Tazobactam
- Antibiotic therapy of 3 or more days
- Given informed consent Group 1
Key exclusion criteria (2 listed)
- Already in another Study
- No useful blood sample
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 |
|---|---|---|
| Drug Level MonitoringFree (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission | Diagnostic test | ICU Patients with Severe Burns, ICU Patients without Burns - Drug Level Monitoring |
Primary outcome
Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission
Time frame: 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission
Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission
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 7 Nov 2017.
- Background: PubMed 20561750Rafla K, Tredget EE. Infection control in the burn unit. Burns. 2011 Feb;37(1):5-15. doi: 10.1016/j.burns.2009.06.198. Epub 2010 Jun 18.
- Background: PubMed 21554211Roberts JA. Using PK/PD to optimize antibiotic dosing for critically ill patients. Curr Pharm Biotechnol. 2011 Dec;12(12):2070-9. doi: 10.2174/138920111798808329.
- Background: PubMed 18783295Blanchet B, Jullien V, Vinsonneau C, Tod M. Influence of burns on pharmacokinetics and pharmacodynamics of drugs used in the care of burn patients. Clin Pharmacokinet. 2008;47(10):635-54. doi: 10.2165/00003088-200847100-00002.
- Background: PubMed 22406650Patel BM, Paratz J, See NC, Muller MJ, Rudd M, Paterson D, Briscoe SE, Ungerer J, McWhinney BC, Lipman J, Roberts JA. Therapeutic drug monitoring of beta-lactam antibiotics in burns patients--a one-year prospective study. Ther Drug Monit. 2012 Apr;34(2):160-4. doi: 10.1097/FTD.0b013e31824981a6.
- Derived from this study: PubMed 30368548Olbrisch K, Kisch T, Thern J, Kramme E, Rupp J, Graf T, Wicha SG, Mailander P, Raasch W. After standard dosage of piperacillin plasma concentrations of drug are subtherapeutic in burn patients. Naunyn Schmiedebergs Arch Pharmacol. 2019 Feb;392(2):229-241. doi: 10.1007/s00210-018-1573-6. Epub 2018 Oct 27.
- Individual participant dataSharing planned: No
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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.
Peter Mailänder, PhD study director
Plastic and Reconstructive Surgery, Hand Surgery, Burn Unit
Walter Raasch, PhD study chair
Institute for experimental and clinical pharmacology and toxicology
Tobias Kisch, MD principal investigator
Plastic and Reconstructive Surgery, Hand Surgery, Burn Unit
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 Antibiotics and Severe Burn, run by University Hospital Schleswig-Holstein 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 7 inclusion and 2 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 7 Nov 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.
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?
Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission (time frame: 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission). 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 NCT03335137, which also lists 5 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 7 Nov 2017.