N/A
N=65
Beta-lactam Pharmacokinetics in Secondary Care
Pharmacokinetics · Beta Lactam Adverse Reaction · Penicillin Allergy
Bottom Line
View on ClinicalTrials.gov: NCT03033394 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Fraction of the Dosing Interval Over Which the Concentration of Unbound Drug is Greater Than the Minimum Inhibitory Concentration (fT>MIC) — 0.457; 0.429; 0.747; 0.417 unitless
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Beta-lactam antibiotic (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fraction of the Dosing Interval Over Which the Concentration of Unbound Drug is Greater Than the Minimum Inhibitory Concentration (fT>MIC) |
0.457; 0.429; 0.747; 0.417; 0.333; 1.63 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adult subjects over 18 years old
- Capacity to consent to participation
- Receiving target antimicrobial (amoxicillin, amoxcillin-clavulanate, cefuroxime, ceftriaxone, flucloxacillin, meropenem, piperacillin-tazobactam) for at least 5 doses prior to sampling
- Appropriate venous access (or for venous access to be gained)
Exclusion Criteria
- Children under 18 years old
- Lacking capacity or prisoner
- Anaemia or bleeding disorder, deemed significant by the patients physician
- Patient's physician deems that they are not suitable for inclusion in the study
- Patients unlikely to be receiving agent for study period
Data sourced from ClinicalTrials.gov (NCT03033394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.