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Beta-lactam Pharmacokinetics in Secondary Care

NCT03033394 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2021-08-30

Study results available
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Summary

Currently in the UK, TDM is routinely performed for aminoglycosides and glycopeptide antimicrobial agents, given fears over the narrow therapeutic window of these agents and the serious adverse events associated with toxicity. However, in critical care the role of TDM for optimisation of therapy has been demonstrated to help optimise dosing of patients who tend to have variable pharmacokinetic parameters (J. A. Roberts et al,). This is of growing importance given that low concentrations of antimicrobial agents, below a micro-organisms minimum inhibitory concentration (MIC) is believed to be a major driver of AMR. The investigators set out to explore whether similar observations in PK-PD target variability are currently being observed across the secondary care setting (outside of critical care) and whether these appear to be impacting on clinical outcomes.

Conditions

  • Pharmacokinetics
  • Beta Lactam Adverse Reaction
  • Penicillin Allergy

Interventions

DRUG

Beta-lactam antibiotic

Routine clinical dosing

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Alison H Holmes, MD MPH MBBS · Health Protection Research Unit in HCAI & AMR

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-12
Primary Completion
2019-08-01
Completion
2019-08-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03033394 on ClinicalTrials.gov