Daptomycin Pharmacokinetics in Critically Ill Patients Un... | NCT01212432

Studies
Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Finding Study

NCT01212432

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Oct 18, 2010Estimated

Enrollment

15Estimated

Phase

Phase 2

Conditions

Gram-Positive Bacterial Infections

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

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Mar 2010Estimated

Completion Date

Mar 2010Estimated

First Submitted Date

Sep 29, 2010

First Submission Date that Met QC Criteria

Sep 29, 2010

First Posted Date

Sep 30, 2010Estimated

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 15, 2010

Last Update Posted Date

Oct 18, 2010Estimated

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Name	Type	Description	Arm Group Labels	Other Names
Daptomycin	Drug	Daptomycin kinetics in CRRT

Measure	Description	Time Frame
Pharmacokinetics		2011

Eligibility Module

Eligibility Criteria

Inclusion criteria:

male or female of 18 years or older
females: negative pregnancy test
Hospitalisation in the medical ICU
High suspicion or evidence of Gram-positive infections requiring antibiotic therapy
Subjects receiving standard antibiotic treatment for Gram-positive infection
Evidence of renal failure
Clinical necessity for continuous renal replacement therapy
Written informed consent signed by the patient or a next of kin and an independent physician in case the patient is not able to sign.

Exclusion criteria:

Skeletal muscle disorders or CPK levels of > 2 x ULN
History of hypersensitivity to the drug
Participation in another study
Subjects with a history of muscle disease
Patients with severe liver function impairment (Child
Life expectancy of less than 5 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
01 Studienregister MasterAdmins	Contact	+41 (0)44 255 11 11

Overall Officials

Name	Affiliation	Role
01 Studienregister MasterAdmins	UniversitaetsSpital Zuerich	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
	Recruiting	Zurich			Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D016908	Gram-Positive Bacterial Infections

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017576	Daptomycin

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided