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Beta-lactam Pharmacokinetics in Secondary Care

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ClinicalTrials.gov Identifier: NCT03033394
Recruitment Status : Completed
First Posted : January 26, 2017
Results First Posted : August 30, 2021
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Pharmacokinetics
Beta Lactam Adverse Reaction
Penicillin Allergy
Intervention Drug: Beta-lactam antibiotic
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Beta-lactam Antibiotic
Hide Arm/Group Description

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

Beta-lactam antibiotic: Routine clinical dosing

Period Title: Completed Sampling
Started 65
Completed 65
Not Completed 0
Period Title: Completed Pharmacokinetic Analysis
Started 65
Completed 59
Not Completed 6
Reason Not Completed
Missing data             1
Oral dosing not incorporated into pharmacokinetic model             3
Level taken at incorrect time             1
Pharmacokinetic soffware unable to generate predicted values             1
Period Title: Completed Final Analysis
Started 59
Completed 58
Not Completed 1
Reason Not Completed
1 participant excluded from final analysis as an outlier (>1.5 x interquartile range)             1
Arm/Group Title Beta-lactam Antibiotic
Hide Arm/Group Description

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

Beta-lactam antibiotic: Routine clinical dosing

Overall Number of Baseline Participants 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
  54.2%
>=65 years
27
  45.8%
[1]
Measure Analysis Population Description:

6 patients excluded from pharmacokinetic analysis:

  • 1 participant missing data
  • 3 oral dosing could not be integrated into model
  • 1 level taken incorrect time
  • 1 model unable to calculate individual predicted value
Age, Continuous   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 59 participants
62
(48 to 72)
[1]
Measure Analysis Population Description:

6 patients excluded from pharmacokinetic analysis:

  • 1 participant missing data
  • 3 oral dosing could not be integrated into model
  • 1 level taken incorrect time
  • 1 model unable to calculate individual predicted value
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Female
18
  30.5%
Male
41
  69.5%
[1]
Measure Analysis Population Description:

6 patients excluded from pharmacokinetic analysis:

  • 1 participant missing data
  • 3 oral dosing could not be integrated into model
  • 1 level taken incorrect time
  • 1 model unable to calculate individual predicted value
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
American Indian or Alaska Native
0
   0.0%
Asian
7
  11.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   3.4%
White
31
  52.5%
More than one race
0
   0.0%
Unknown or Not Reported
19
  32.2%
[1]
Measure Analysis Population Description:

6 patients excluded from pharmacokinetic analysis:

  • 1 participant missing data
  • 3 oral dosing could not be integrated into model
  • 1 level taken incorrect time
  • 1 model unable to calculate individual predicted value
1.Primary Outcome
Title Fraction of the Dosing Interval Over Which the Concentration of Unbound Drug is Greater Than the Minimum Inhibitory Concentration (fT>MIC)
Hide Description 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.
Time Frame Two to 10 samples taken during the first 120 hours of antimicrobial therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amoxicillin Co-amoxiclav Ceftriaxone Flucloxacillin Meropenem Piperacillin-tazobactam
Hide Arm/Group Description:

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

Beta-lactam antibiotic: Routine clinical dosing

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

Beta-lactam antibiotic: Routine clinical dosing

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

Beta-lactam antibiotic: Routine clinical dosing

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

Beta-lactam antibiotic: Routine clinical dosing

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

Beta-lactam antibiotic: Routine clinical dosing

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

Beta-lactam antibiotic: Routine clinical dosing

Overall Number of Participants Analyzed 3 7 11 14 13 10
Median (Inter-Quartile Range)
Unit of Measure: unitless
0.457
(0.417 to 0.479)
0.429
(0.417 to 0.479)
0.747
(0.741 to 1.04)
0.417
(0.285 to 0.700)
0.333
(0.319 to 0.345)
1.63
(0.971 to 1.78)
Time Frame Mortality outcome collected from time target antimicrobial commenced until time target antimicrobial stopped. This was median 9 days (interquartile range 6-13 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Beta-lactam Antibiotic
Hide Arm/Group Description

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

Beta-lactam antibiotic: Routine clinical dosing

All-Cause Mortality
Beta-lactam Antibiotic
Affected / at Risk (%)
Total   1/59 (1.69%) 
Hide Serious Adverse Events
Beta-lactam Antibiotic
Affected / at Risk (%)
Total   0/59 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Beta-lactam Antibiotic
Affected / at Risk (%)
Total   0/59 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Richard Wilson
Organization: Imperial College London
Phone: 02033132732
EMail: richard.wilson@imperial.ac.uk
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03033394    
Other Study ID Numbers: 207217
16/LO/2179 ( Other Identifier: REC )
33017 ( Other Identifier: NIHR CRN CPMS )
First Submitted: January 19, 2017
First Posted: January 26, 2017
Results First Submitted: August 3, 2020
Results First Posted: August 30, 2021
Last Update Posted: August 30, 2021