Beta-lactam Pharmacokinetics in Secondary Care

NCT03033394 | Completed Results

• 3 other identifiers: 20721716/LO/217933017
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Penicillins; Drug Monitoring; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Fraction of the Dosing Interval Over Which the Concentration of Unbound Drug is Greater Than the Minimum Inhibitory Concentration (fT>MIC)

  Minimum inhibitory concentration (MIC) is the concentration required to visibly inhibit microbial growth in vitro. The MIC for each drug was defined by non-species related breakpoints provided in EUCAST v11.0. Results are given as a fraction of the dosing interval over which the concentration of the unbound drug is greater than the MIC.

  Two to 10 samples taken during the first 120 hours of antimicrobial therapy

Study Arms (1)

Beta-lactam antibiotic

Observational pharmacokinetic study of non-critical care patients receiving beta-lactam antibiotics for management of infections.

Drug: Beta-lactam antibiotic

Interventions

Beta-lactam antibiotic DRUG

Routine clinical dosing

Also known as: Penicillin

Beta-lactam antibiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants from a non-critical care setting will be recruited after receiving at least 5 doses of target antimicrobial. Participants receiving oral and intravenous therapy will be eligible.

You may qualify if:

• 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)

You may not qualify if:

• Children under 18 years old
• Lacking capacity or prisoner
• Anaemia or bleeding disorder, deemed significant by the patients physician
• Patients unlikely to be receiving agent for study period

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Interventions

Monobactams; Penicillins

Intervention Hierarchy (Ancestors)

beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Richard Wilson
• Organization: Imperial College London

richard.wilson@imperial.ac.uk

02033132732

Study Officials

• Alison H Holmes, MD MPH MBBS

  Health Protection Research Unit in HCAI & AMR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 26, 2017
• Study Start: July 12, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 30, 2021
• Results First Posted: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)