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Minimally Invasive Sensing of Beta-lactam Antibiotics (MISBL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03847610
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
This study is an in-house feasibility study of a microneedle biosensor developed within Imperial College London.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Phenoxymethyl Penicillin Device: Microneedle array Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Microneedle Sensing of Beta-lactam Antibiotic Concentrations in Human Interstitial Fluid
Actual Study Start Date : April 12, 2018
Actual Primary Completion Date : August 10, 2018
Actual Study Completion Date : August 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy volunteer Drug: Phenoxymethyl Penicillin
Phenoxymethylpenicillin tablets, 500mg every six hours for six doses, starting the day before study

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.




Primary Outcome Measures :
  1. Assessment of the biosensors ability to track phenoxymethylpenicillin concentrations compared to observations made by microdialysis and blood sampling [ Time Frame: Up to 12 hours ]
    Bland-Altman plot to describe agreement between interstitial phenoxymethylpenicillin concentrations and microneedle data



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847610


Locations
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United Kingdom
NIHR Imperial CRF
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Alison H Holmes, MD MPH MBBS Health Protection Research Unit in HCAI & AMR
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03847610    
Other Study ID Numbers: 17IC4051
236047 ( Other Identifier: IRAS )
18/LO/0054 ( Other Identifier: London-Harrow REC )
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Imperial College London:
Pharmacokinetics
Penicillin V
Penicillins
Proof of Concept Study
Clinical Trial, Phase I
Microneedle array
Additional relevant MeSH terms:
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Penicillins
Penicillin V
Anti-Bacterial Agents
Anti-Infective Agents