Evaluation of Single-dose Pharmacokinetics of Intravenous... | NCT02241941

Studies
Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury

NCT02241941

Sponsor

University of Zurich

Status

Withdrawn

Last Update Posted

Oct 28, 2016Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Burn Injury

Interventions

Daptomycin

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EK-1748

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Assessment of daptomycin concentrations with microdialysis technically not feasible

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Sep 13, 2014

First Submission Date that Met QC Criteria

Sep 15, 2014

First Posted Date

Sep 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2016

Last Update Posted Date

Oct 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Daptomycin	Experimental		Drug: Daptomycin

Name	Type	Description	Arm Group Labels	Other Names
Daptomycin	Drug		Daptomycin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic parameters of daptomycin		up to 30 days

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rainer Weber, MD Professor	Division of Infectious Diseases and Hospital Epidemiology, Universitit Hospital Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich		Zurich		8091	Switzerland

ID	Term
D002056	Burns

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D017576	Daptomycin

Ancestor Terms

ID	Term
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D055666	Lipopeptides

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Browse Branches

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