DetectAB - Detecting Antibiotics

Study Overview
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Brief Summary
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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.

Official Title
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DetectAB - Detecting Antibiotics - A Pilot Project

Conditions
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Antibiotic Drug Concentration in Sweat

Intervention / Treatment
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* Diagnostic Test: analysis of last resort antibiotic drug (Flucloxacillin, Imipenem, Vancomycin or Cefepim) in sweat and blood


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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)|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibiotic drug monitoring in sweat