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DetectAB - Detecting Antibiotics (DetectAB)

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ClinicalTrials.gov Identifier: NCT03678142
Recruitment Status : Active, not recruiting
First Posted : September 19, 2018
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
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.

Condition or disease Intervention/treatment
Antibiotic Drug Concentration in Sweat Diagnostic Test: analysis of last resort antibiotic drug (Flucloxacillin, Imipenem, Vancomycin or Cefepim) in sweat and blood

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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DetectAB - Detecting Antibiotics - A Pilot Project
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : February 19, 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sweat


Intervention Details:
  • 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)


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In- patients currently receiving intravenous antibiotic therapy (Cefepim, Flucloxacillin, Imipenem or Vancomycin) at University Hospital Basel/ Switzerland
Criteria

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

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): NCT03678142


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Jens Eckstein, PD Dr. med Chief Clinical Medical Office

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03678142     History of Changes
Other Study ID Numbers: 2018-01155; me18Eckstein
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Basel, Switzerland:
antibiotic drug monitoring in sweat

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Vancomycin
Imipenem
Floxacillin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents