Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients

April 18, 2019 updated by: University Hospital Tuebingen
10 patients with chronic heart failure receiving daptomycin therapy after implantation of a left ventricular heart assist system. Measurement of daptomycin levels in drainage fluids (mediastinal and pleural drainage systems) and in blood samples.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

9

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

  • Germany
      • Tuebingen, Germany, 72076
        • University Hospital Tuebingen

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients after heart assist device implantation with wound drainage receiving daptomycin therapy

Description

Inclusion Criteria:

  • written consent
  • heart assist device implantation
  • wound drainage
  • daptomycin therapy

Exclusion Criteria:

  • pregnancy
  • no written consent possible
  • absence of wound drainage
  • allergy to study medication
  • acute rhabdomyolysis

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
levels of Daptomycin in drainage fluid
Time Frame: 4 days
Pharmacokinetics of Daptomycin in intensive care patients with wound drainage after surgery (LVAD implantation)
4 days
levels of Daptomycin in blood samples
Time Frame: 4 days
Pharmacokinetics of Daptomycin in intensive care patients after surgery (LVAD implantation)
4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
infections
Time Frame: 14 days
incidence of gram-positive infections
14 days

Collaborators and Investigators

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

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Stefanie Prohaska, MD, University Hospital Tuebingen

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, 2016

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

December 21, 2016

First Posted (Estimate)

December 28, 2016

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 18, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dapto

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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