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Determining Drug Levels of Beta-lactam Antibiotics in Severe Burned Patients

Determining Drug Levels of Beta-lactam Antibiotics in Severe Burned Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03335137
Acronym
MSBV
Enrollment
35
Registered
2017-11-07
Start date
2014-05-01
Completion date
2016-12-31
Last updated
2017-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotics, Intensive Care, Severe Burn

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTDrug Level Monitoring

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

Sponsors

Medical Clinic III
CollaboratorUNKNOWN
Dezernat Apotheke
CollaboratorUNKNOWN
University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Already in another Study * No useful blood sample

Design outcomes

Primary

MeasureTime frameDescription
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 admission1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admissionFree (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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026