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Completed

NCT Number: NCT03678142

DetectAB - Detecting Antibiotics

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.

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Key information

Conditions

Antibiotic Drug Concentration in Sweat

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

analysis of last resort antibiotic drug (Flucloxacillin, Imipenem, Vancomycin or Cefepim) in sweat and blood

Diagnostic Test

blood draw (4.7 ml EDTA) and sweat sample taken (Macroduct Sweat Collecting System)

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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 outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

DetectAB - Detecting Antibiotics - A Pilot Project

Acronym: DetectAB

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2018
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.