DetectAB - Detecting Antibiotics

Completed

• Conditions: Antibiotic Drug Concentration in Sweat

• Registration Number: NCT03678142
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-19
• Study Start: 2018-10-01
• Primary Completion: 2019-02-19
• Study Completion: 2019-10-31
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in detection of last resort antibiotic Imipenem in sweat.	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.	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 Flucloxacillin in sweat.	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 Cefepim in sweat.	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

Name	Time	Method
concentration (yg/ml) of last resort antibiotic Imipenem in sweat.	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.	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.	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
concentration (yg/ml) of last resort antibiotic Flucloxacillin in sweat.	sample taken immediately before and 45 minutes after Flucloxacillin application	quantification of Flucloxacillin in sweat by mass spectrometry.

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland