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Clinical Trials/DRKS00011159
DRKS00011159
Completed
Phase 3

Therapeutic drug monitoring-based dose optimisation of piperacillin in patients with severe sepsis or septic shock to investigate effects on organ functions and survival: a prospective, multicenter, randomized controlled trial - Target

Friedrich-Schiller-Universität Jena0 sites254 target enrollmentOctober 10, 2016
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ConditionsR65.1R57.2Systemic Inflammatory Response Syndrome of infectious origin with organ failureSeptic shock

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
R65.1
Sponsor
Friedrich-Schiller-Universität Jena
Enrollment
254
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 10, 2016
End Date
December 6, 2020
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients with severe sepsis or septic shock
  • •onset of severe sepsis or septic shock not longer than 24 hours prior
  • •to randomization
  • •Antimicrobial therapy with piperacillin planned or started
  • •age \=18 years
  • •written informed consent of the patient or legal representative

Exclusion Criteria

  • •pregnant or breast\-feeding women
  • •anamnestic known hypersensitivity against beta\-lactam antibiotics or another part of the investigational medicinal product
  • •previous treatment with piperacillin (in combination with tazobactam) \> 24 hours before randomization
  • •participation in another interventional clinical trial
  • •previous participation (TARGET)
  • •limits of therapy or cessation
  • •impaired liver function (Child\-Pugh C)
  • •life expectancy \< 28 day due to accompanying illnesses
  • •piperacillin\-measurement impossible within 24 hours after randomization

Outcomes

Primary Outcomes

Not specified

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