Status:
COMPLETED
Closed-loop Control of Penicillin Delivery
Lead Sponsor:
Imperial College London
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is an in-house feasibility study of penicillin biosensor technology linked with closed-loop control for the automated delivery of penicillin antibiotics.
Detailed Description
Outline of the study: This study will take place at the Imperial Clinical Research Facility (ICRF). Twenty healthy volunteers will be recruited to take part in three visits to the ICRF. These will ea...
Eligibility Criteria
Inclusion
- Adult \>18 years old.
- Healthy adults, with no evidence of infection.
- Previously received penicillin with no adverse effects.
Exclusion
- \< 18 years old.
- High risk of skin and soft tissue infection or local skin and soft tissue infection near sensor site.
- Hypersensitivity to adhesive strips or active dermatitis.
- Penicillin hypersensitivity 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).
- Renal impairment on screening bloods (defined as a Cockcroft-Gault creatinine clearance \<60mL/min).
- Liver impairment on screening bloods (defined as ALT, ALP or bilirubin 3x ULN).
- Implantable electronic device in-situ if wearing a microneedle array device.
- Pregnant.
Key Trial Info
Start Date :
November 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04053140
Start Date
November 5 2019
End Date
May 31 2024
Last Update
July 10 2024
Active Locations (1)
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1
NIHR Imperial CRF
London, United Kingdom, W12 0HS