DetectAB - Detecting Antibiotics

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Completed
• CT.gov ID: NCT03678142
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Actual Duration (Months): 13
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Antibiotic Drug Concentration in Sweat	Diagnostic Test: analysis of last resort antibiotic drug (Flucloxacillin, Imipenem, Vancomycin or Cefepim) in sweat and blood

Study Design

• Study Type: Observational
• Actual Enrollment: 17 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: DetectAB - Detecting Antibiotics - A Pilot Project
• Actual Study Start Date: Oct 1, 2018
• Actual Primary Completion Date: Feb 19, 2019
• Actual Study Completion Date: Oct 31, 2019

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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).

3. 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).

4. 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

1. 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.

2. 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

3. 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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Basel	Basel		Switzerland	4031

Sponsors and Collaborators

• University Hospital, Basel, Switzerland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT03678142
• Other Study ID Numbers: 2018-01155; me18Eckstein
• First Posted: Sep 19, 2018
• Last Update Posted: Dec 11, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Basel, Switzerland: antibiotic drug monitoring in sweat
• Additional relevant MeSH terms: Anti-Bacterial Agents; Vancomycin; Imipenem; Floxacillin

Study Results

No Results Posted as of Dec 11, 2019