Trial Outcomes & Findings for Minimally Invasive Sensing of Beta-lactam Antibiotics (NCT NCT03847610)

Last Updated: 2024-03-27

Results Overview

Bland-Altman plot to describe agreement between interstitial phenoxymethylpenicillin concentrations and microneedle data (mean difference between microneedle and microdialysis measurements)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

11 participants

Primary outcome timeframe

Up to 12 hours

Results posted on

2024-03-27

Participant Flow

One volunteer withdrew consent to undergo microdialysis on the study day and was withdrawn from the analysis. The participant did not cite a reason for declining microdialysis catheter insertion. Therefore, ten volunteers were included in the study.

Participant milestones

Participant milestones
Measure	Healthy Volunteer Phenoxymethyl Penicillin: Phenoxymethylpenicillin tablets, 500mg every six hours for six doses, starting the day before study Microneedle array: The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Volunteer Phenoxymethyl Penicillin: Phenoxymethylpenicillin tablets, 500mg every six hours for six doses, starting the day before study Microneedle array: The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Volunteer n=10 Participants Phenoxymethyl Penicillin: Phenoxymethylpenicillin tablets, 500mg every six hours for six doses, starting the day before study Microneedle array: The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed.
Age, Continuous	42 years STANDARD_DEVIATION 14 • n=10 Participants
Sex: Female, Male Female	3 Participants n=10 Participants
Sex: Female, Male Male	7 Participants n=10 Participants
Region of Enrollment United Kingdom	10 participants n=10 Participants
BMI	24 kg/m^2 STANDARD_DEVIATION 3 • n=10 Participants
Creatinine clearance	114 mL/min STANDARD_DEVIATION 29 • n=10 Participants
Height	174 cm STANDARD_DEVIATION 11 • n=10 Participants
Weight	74 kg STANDARD_DEVIATION 15 • n=10 Participants

PRIMARY outcome

Timeframe: Up to 12 hours

Bland-Altman plot to describe agreement between interstitial phenoxymethylpenicillin concentrations and microneedle data (mean difference between microneedle and microdialysis measurements)

Outcome measures

Outcome measures
Measure	Healthy Volunteer n=10 Participants Phenoxymethyl Penicillin: Phenoxymethylpenicillin tablets, 500mg every six hours for six doses, starting the day before study Microneedle array: The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed.
Assessment of the Biosensors Ability to Track Phenoxymethylpenicillin Concentrations Compared to Observations Made by Microdialysis and Blood Sampling	-0.16 mg/L Interval -1.3 to 0.82

Adverse Events

Healthy Volunteer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard Wilson

Imperial College London

Phone: 02033132732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place