Minimally Invasive Sensing of Beta-lactam Antibiotics
MISBL
Microneedle Sensing of Beta-lactam Antibiotic Concentrations in Human Interstitial Fluid
3 other identifiers
interventional
11
1 country
1
Brief Summary
This study is an in-house feasibility study of a microneedle biosensor developed within Imperial College London.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2018
CompletedFirst Submitted
Initial submission to the registry
February 7, 2019
CompletedFirst Posted
Study publicly available on registry
February 20, 2019
CompletedResults Posted
Study results publicly available
December 29, 2020
CompletedMarch 27, 2024
March 1, 2024
4 months
February 7, 2019
November 6, 2020
March 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of the Biosensors Ability to Track Phenoxymethylpenicillin Concentrations Compared to Observations Made by Microdialysis and Blood Sampling
Bland-Altman plot to describe agreement between interstitial phenoxymethylpenicillin concentrations and microneedle data (mean difference between microneedle and microdialysis measurements)
Up to 12 hours
Study Arms (1)
Healthy volunteer
EXPERIMENTALInterventions
Phenoxymethylpenicillin tablets, 500mg every six hours for six doses, starting the day before study
The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed.
Eligibility Criteria
You may qualify if:
- Adult \>18 years old
- Healthy with no evidence of active infection
- Previously received penicillin with no adverse effects
You may not qualify if:
- High risk of skin soft tissue infection or local skin and soft tissue infection near sensor site
- Previous history of allergies to adhesive strips or active dermatitis
- Penicillin allergy or previous adverse event whilst receiving penicillin
- Anaemia on screening bloods (defined as haemoglobin \<13 g/dL in males and \<12 g/dL in females)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NIHR Imperial CRF
London, W12 0HS, United Kingdom
Related Publications (1)
Rawson TM, Gowers SAN, Freeman DME, Wilson RC, Sharma S, Gilchrist M, MacGowan A, Lovering A, Bayliss M, Kyriakides M, Georgiou P, Cass AEG, O'Hare D, Holmes AH. Microneedle biosensors for real-time, minimally invasive drug monitoring of phenoxymethylpenicillin: a first-in-human evaluation in healthy volunteers. Lancet Digit Health. 2019 Nov;1(7):e335-e343. doi: 10.1016/S2589-7500(19)30131-1. Epub 2019 Sep 30.
PMID: 33323208DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard Wilson
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Alison H Holmes, MD MPH MBBS
Health Protection Research Unit in HCAI & AMR
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2019
First Posted
February 20, 2019
Study Start
April 12, 2018
Primary Completion
August 10, 2018
Study Completion
August 10, 2018
Last Updated
March 27, 2024
Results First Posted
December 29, 2020
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share