DetectAB – Detecting Antibiotics

Overview

The secretion of different kinds of antibiotic drugs in sweat is investigated. The concentration and pharmacodynamics of antibiotic drugs in sweat and blood will be compared.

Full Title of Study: “DetectAB – Detecting Antibiotics – A Pilot Project”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 19, 2019

Interventions

  • Diagnostic Test: analysis of last resort antibiotic drug (Flucloxacillin, Imipenem, Vancomycin or Cefepim) in sweat and blood
    • blood draw (4.7 ml EDTA) and sweat sample taken (Macroduct Sweat Collecting System)

Clinical Trial Outcome Measures

Primary Measures

  • Change in detection of last resort antibiotic Flucloxacillin in sweat.
    • Time Frame: sample taken immediately before and 45 minutes after Flucloxacillin application
    • detection of Flucloxacillin in sweat by mass spectrometry (proof of concept).
  • Change in detection of last resort antibiotic Imipenem in sweat.
    • Time Frame: sample taken immediately before and 60 minutes after Imipenem application
    • detection of Imipenem in sweat by mass spectrometry (proof of concept).
  • Change in detection of last resort antibiotic Vancomycin in sweat.
    • Time Frame: sample taken immediately before and 5 hours after Vancomycin application
    • detection of Vancomycin in sweat by mass spectrometry (proof of concept).
  • Change in detection of last resort antibiotic Cefepim in sweat.
    • Time Frame: sample taken immediately before Cefepim application and 2 hours, 4 hours, 6 hours, 8 hours after Cefepim application
    • detection of Cefepim in sweat by mass spectrometry (proof of concept).

Secondary Measures

  • concentration (yg/ml) of last resort antibiotic Flucloxacillin in sweat.
    • Time Frame: sample taken immediately before and 45 minutes after Flucloxacillin application
    • quantification of Flucloxacillin in sweat by mass spectrometry.
  • concentration (yg/ml) of last resort antibiotic Imipenem in sweat.
    • Time Frame: sample taken immediately before and 60 minutes after Imipenem application
    • quantification of Imipenem in sweat by mass spectrometry
  • concentration (yg/ml) of last resort antibiotic Vancomycin in sweat.
    • Time Frame: sample taken immediately before and 5 hours after Vancomycin application
    • quantification of Vancomycin in sweat by mass spectrometry
  • concentration (yg/ml) of last resort antibiotic Cefepim in sweat.
    • Time Frame: sample taken immediately before Cefepim application and 2 hours, 4 hours, 6 hours, 8 hours after Cefepim application
    • quantification of Cefepim in sweat and blood by mass spectrometry

Participating in This Clinical Trial

Inclusion Criteria

  • Adult patients – Ability to understand the purpose of the study, provide signed and dated informed consent and qualify for therapeutic drug monitoring – In-patients receiving intravenous therapy with last resort antibiotics Cefepim, Floxapen, Imipenem or Vancomycin for at least 24 hours – Glomerular Filtration Rate >/= 50 ml/Min Exclusion Criteria:

  • Glomerular Filtration Rate < 50 ml/Min

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Basel, Switzerland
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jens Eckstein, PD Dr. med, Principal Investigator, Chief Clinical Medical Office

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