Closed-loop Control of Penicillin Delivery

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Imperial College London
• Treatments: Penicillin G; Penicillin G Benzathine; Penicillin G Procaine; Penicillins

Criteria

Inclusion Criteria:

• Adult >18 years old.

• Healthy adults, with no evidence of infection.

• Previously received penicillin with no adverse effects.

Exclusion Criteria:

• < 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.