NCT02241941

Brief Summary

The purpose of this study is to determine single dose pharmacokinetics of daptomycin consecutively in 10 patients on three different time points after severe burn injury.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

September 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

2.1 years

First QC Date

September 13, 2014

Last Update Submit

October 27, 2016

Conditions

Burn Injury

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic parameters of daptomycin

    up to 30 days

Secondary Outcomes (2)

  • Correlation of daptomycin plasma concentrations with tissue concentration

    up to 30 days

  • degree of variability of daptomycin pk parameters in dependency of body surface area burned

    up to 30 days

Study Arms (1)

Daptomycin

EXPERIMENTAL
Drug: Daptomycin

Interventions

DaptomycinDRUG
Daptomycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female of 18 years or older
  • Second and/or third degree thermal injury
  • Total body surface area burned ≥ 15%
  • Hospitalisation in the ICU for burn injured patients of the University Hospital Zürich
  • Probability of ICU stay of \>14 days
  • Written informed consent by the patient or in patients unable to be informed or to sign according to section 4.4 of the study protocol

You may not qualify if:

  • Evidence of renal failure (Creatinine clearance \<30ml/min) or continuous renal replacement therapy such as continuous hemofiltration
  • History of muscle disease or skeletal muscle disorder
  • Creatine-phosphokinase (CPK) ≥ 5 times the upper limit of normal (ULN)
  • History of hypersensitivity to the drug
  • Pregnancy
  • Severe coagulation disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Burns

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Rainer Weber, MD Professor

    Division of Infectious Diseases and Hospital Epidemiology, Universitit Hospital Zurich

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2014

First Posted

September 16, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

CH(1)