DetectAB - Detecting Antibiotics

Antibiotic Drug Concentration in Sweat Clinical Trial

— DetectAB  

Official title:

DetectAB - Detecting Antibiotics - A Pilot Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03678142
• Other study ID #: 2018-01155; me18Eckstein
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: December 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 31, 2019
• Est. primary completion date: February 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Drug Concentration in Sweat

Intervention

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)

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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