Clinical trial NCT03678142: DetectAB - Detecting Antibiotics
Official title: DetectAB - Detecting Antibiotics - A Pilot Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibiotic Drug Concentration in Sweat
Keywords: antibiotic drug monitoring in sweat
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In- patients currently receiving intravenous antibiotic therapy (Cefepim, Flucloxacillin, Imipenem or Vancomycin) at 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.


Eligibility 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

Primary outcomes:
measure: Change in detection of last resort antibiotic Flucloxacillin in sweat.
timeFrame: sample taken immediately before and 45 minutes after Flucloxacillin application
measure: Change in detection of last resort antibiotic Imipenem in sweat.
timeFrame: sample taken immediately before and 60 minutes after Imipenem application
measure: Change in detection of last resort antibiotic Vancomycin in sweat.
timeFrame: sample taken immediately before and 5 hours after Vancomycin application
measure: Change in detection of last resort antibiotic Cefepim in sweat.
timeFrame: sample taken immediately before Cefepim application and 2 hours, 4 hours, 6 hours, 8 hours after Cefepim application
Secondary outcomes:
measure: concentration (yg/ml) of last resort antibiotic Flucloxacillin in sweat.
timeFrame: sample taken immediately before and 45 minutes after Flucloxacillin application
measure: concentration (yg/ml) of last resort antibiotic Imipenem in sweat.
timeFrame: sample taken immediately before and 60 minutes after Imipenem application
measure: concentration (yg/ml) of last resort antibiotic Vancomycin in sweat.
timeFrame: sample taken immediately before and 5 hours after Vancomycin application
measure: concentration (yg/ml) of last resort antibiotic Cefepim in sweat.
timeFrame: sample taken immediately before Cefepim application and 2 hours, 4 hours, 6 hours, 8 hours after Cefepim application
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Chief Clinical Medical Office
name: Jens Eckstein, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brasier N, Widmer A, Osthoff M, Mutke M, De Ieso F, Brasier-Lutz P, Wolfe L, Aithal V, Broeckling CD, Prenni J, Eckstein J. Non-invasive Drug Monitoring of beta-Lactam Antibiotics Using Sweat Analysis-A Pilot Study. Front Med (Lausanne). 2020 Aug 25;7:476. doi: 10.3389/fmed.2020.00476. eCollection 2020.