Status:

COMPLETED

The OPTIMAL TDM Study: Determining Optimal Beta-lactam Plasma Concentrations Through Therapeutic Drug Monitoring

Lead Sponsor:

University of Geneva, Switzerland

Collaborating Sponsors:

University Hospital, Geneva

Conditions:

Beta-lactam Antibiotics

Therapeutic Drug Monitoring

Eligibility:

All Genders

18+ years

Brief Summary

Little is known of beta-lactam antibiotics' true therapeutic plasma concentration range. The aims of this study are to define evidence-based, safe and effective upper and lower limits of the plasma co...

Detailed Description

Little is known of beta-lactam antibiotics' true therapeutic plasma concentration range. The aims of this study are to define evidence-based, safe and effective upper and lower limits of the plasma co...

Eligibility Criteria

Inclusion

  • \- Hospitalized patients with suspected or confirmed systemic bacterial infection:
  • Receiving either imipenem-cilastatin, meropenem, amoxicillin (±clavulanic acid), flucloxacillin, piperacillin-tazobactam, ceftazidime or cefepime
  • Aged ≥18 years
  • Requiring intensive or intermediate-intensive (step-down) care OR severely immunosuppressed (see definitions)

Exclusion

  • Planned imminent transfer to an outside hospital
  • Poor prognosis with life expectancy \<1 week and/or intended transition to palliative care

Key Trial Info

Start Date :

January 14 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2023

Estimated Enrollment :

771 Patients enrolled

Trial Details

Trial ID

NCT03790631

Start Date

January 14 2019

End Date

December 31 2023

Last Update

May 20 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Geneva University Hospitals

Geneva, Canton of Geneva, Switzerland, 1205