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Phase 1 Completed N=11 Device Feasibility

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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

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