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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03004066
Other study ID # Dapto
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2016
Est. completion date March 31, 2019

Study information

Verified date April 2018
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date March 31, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Daptomycin
standard care

Locations

Country Name City State
Germany University Hospital Tuebingen Tuebingen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary levels of Daptomycin in drainage fluid Pharmacokinetics of Daptomycin in intensive care patients with wound drainage after surgery (LVAD implantation) 4 days
Primary levels of Daptomycin in blood samples Pharmacokinetics of Daptomycin in intensive care patients after surgery (LVAD implantation) 4 days
Secondary infections incidence of gram-positive infections 14 days
See also
  Status Clinical Trial Phase
Completed NCT05408104 - Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients