Antibiotic Drug Concentration in SweatDetectABNCT03678142
DetectAB - Detecting Antibiotics
An observational study of Antibiotic Drug Concentration in Sweat, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic Drug Concentration in Sweat
- What is being tested?
- analysis of last resort antibiotic drug (Flucloxacillin, Imipenem, Vancomycin or Cefepim) in sweat and blood
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2018to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In- patients currently receiving intravenous antibiotic therapy (Cefepim, Flucloxacillin, Imipenem or Vancomycin) at University Hospital Basel/ Switzerland
Who may be able to join
- 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
Who cannot join
- Glomerular Filtration Rate < 50 ml/Min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Antibiotic Drug Concentration in Sweat
- Being tested
- analysis of last resort antibiotic drug (Flucloxacillin, Imipenem, Vancomycin or Cefepim) in sweat and blood
- Keywords
- antibiotic drug monitoring in sweat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of last resort antibiotic drug (Flucloxacillin, Imipenem, Vancomycin or Cefepim) in sweat and bloodDiagnostic test
blood draw (4.7 ml EDTA) and sweat sample taken (Macroduct Sweat Collecting System)
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in detection of last resort antibiotic Flucloxacillin in sweat.
detection of Flucloxacillin in sweat by mass spectrometry (proof of concept).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: sample taken immediately before Cefepim application and 2 hours, 4 hours, 6 hours, 8 hours after Cefepim application
Secondary outcomes (4)
concentration (yg/ml) of last resort antibiotic Flucloxacillin in sweat.
quantification of Flucloxacillin in sweat by mass spectrometry.
Measured: 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
Measured: 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
Measured: 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
Measured: sample taken immediately before Cefepim application and 2 hours, 4 hours, 6 hours, 8 hours after Cefepim application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start1 Oct 2018
- Primary completion19 Feb 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Drug Concentration in SweatStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Eckstein, PD Dr. med, Principal investigator, Chief Clinical Medical Office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678142
- Sponsor's protocol ID
- 2018-01155; me18Eckstein
- Other IDs
- 2018
- Acronym
- DetectAB
- Status last verified
- Dec 2019
- First submitted
- 21 Aug 2018
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32984371
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DetectAB - Detecting Antibiotics - A Pilot Project
- ClinicalTrials.gov ID
- NCT03678142
- Acronym / sponsor ID
- DetectAB / 2018-01155; me18Eckstein
- Conditions
- Antibiotic Drug Concentration in Sweat
- Keywords
- antibiotic drug monitoring in sweat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In- patients currently receiving intravenous antibiotic therapy (Cefepim, Flucloxacillin, Imipenem or Vancomycin) at University Hospital Basel/ Switzerland
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Glomerular Filtration Rate < 50 ml/Min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analysis of last resort antibiotic drug (Flucloxacillin, Imipenem, Vancomycin or Cefepim) in sweat and bloodblood draw (4.7 ml EDTA) and sweat sample taken (Macroduct Sweat Collecting System) | Diagnostic test | – |
Primary outcome
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).
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).
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).
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).
4 secondary outcomes
concentration (yg/ml) of last resort antibiotic Flucloxacillin in sweat.
Time frame: 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
concentration (yg/ml) of last resort antibiotic Vancomycin in sweat.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Derived from this study: PubMed 32984371Brasier 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Eckstein, PD Dr. med principal investigator
Chief Clinical Medical Office
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Drug Concentration in Sweat, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in detection of last resort antibiotic Flucloxacillin in sweat. (time frame: sample taken immediately before and 45 minutes after Flucloxacillin application). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03678142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.