DetectAB - Detecting Antibiotics (DetectAB)

December 10, 2019 updated by: University Hospital, Basel, Switzerland

DetectAB - Detecting Antibiotics - A Pilot Project

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

In- patients currently receiving intravenous antibiotic therapy (Cefepim, Flucloxacillin, Imipenem or Vancomycin) at University Hospital Basel/ Switzerland

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
sample taken immediately before and 45 minutes after Flucloxacillin application
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).
sample taken immediately before and 60 minutes after Imipenem application
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).
sample taken immediately before and 5 hours after Vancomycin application
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).
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.
Time Frame: sample taken immediately before and 45 minutes after Flucloxacillin application
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.
Time Frame: sample taken immediately before and 60 minutes after Imipenem application
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.
Time Frame: sample taken immediately before and 5 hours after Vancomycin application
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.
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
sample taken immediately before Cefepim application and 2 hours, 4 hours, 6 hours, 8 hours after Cefepim application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Jens Eckstein, PD Dr. med, Chief Clinical Medical Office

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2018

Primary Completion (ACTUAL)

February 19, 2019

Study Completion (ACTUAL)

October 31, 2019

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

September 18, 2018

First Posted (ACTUAL)

September 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-01155; me18Eckstein

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Antibiotic Drug Concentration in Sweat

Clinical Trials on analysis of last resort antibiotic drug (Flucloxacillin, Imipenem, Vancomycin or Cefepim) in sweat and blood

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe