Phase 1
Completed N=11
Minimally Invasive Sensing of Beta-lactam Antibiotics
Healthy Volunteers
Source: ClinicalTrials.gov NCT03847610 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Assessment of the Biosensors Ability to Track Phenoxymethylpenicillin Concentrations Compared to Observations Made by Microdialysis and Blood Sampling — -0.16 mg/L
Summary
This study is an in-house feasibility study of a microneedle biosensor developed within Imperial College London.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of the Biosensors Ability to Track Phenoxymethylpenicillin Concentrations Compared to Observations Made by Microdialysis and Blood Sampling |
-0.16 | — |
Eligibility Criteria
Inclusion Criteria
- Adult >18 years old
- Healthy with no evidence of active infection
- Previously received penicillin with no adverse effects
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03847610). 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. Informational only — not medical advice.