NCT03004066

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2018

Enrollment Period

2.5 years

First QC Date

November 16, 2016

Last Update Submit

April 18, 2019

Conditions

Heart Assist Device

Outcome Measures

Primary Outcomes (2)

  • levels of Daptomycin in drainage fluid

    Pharmacokinetics of Daptomycin in intensive care patients with wound drainage after surgery (LVAD implantation)

    4 days

  • levels of Daptomycin in blood samples

    Pharmacokinetics of Daptomycin in intensive care patients after surgery (LVAD implantation)

    4 days

Secondary Outcomes (1)

  • infections

    14 days

Interventions

DaptomycinDRUG

standard care

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

MeSH Terms

Interventions

Daptomycin

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Stefanie Prohaska, MD

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2016

First Posted

December 28, 2016

Study Start

October 1, 2016

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

April 19, 2019

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)