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Closed-loop Control of Penicillin Delivery

NCT04053140 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-07-10

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DEVICE

Microneedle array

The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed.

DEVICE

Microneedle array and closed-loop control of penicillin delivery

The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed. Microneedle data will be used to titrate benzylpenicillin dosage according to PK-PD target.

DRUG

Penicillin G_1200mg

Benzylpenicillin IV 1200mg administered every 4 hours.

DRUG

Penicillin G_2400mg

Benzylpenicillin IV administered in intermittent dosing schedule. Dosage to be determined by closed-loop algorithm. Limits set to 2400mg every 4 hours.

DRUG

Penicillin G_600mg/hr

Benzylpenicillin IV administered in continuous dosing schedule. Dosage to be determined by closed-loop algorithm. Initial loading dose, and limits set to 600mg/hr.

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Alison H Holmes, MD MPH MBBS · Health Protection Research Unit in HCAI & AMR

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04053140 on ClinicalTrials.gov