Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration

NCT ID: NCT01171547

Last Updated: 2010-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Brief Summary

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The purpose is to investigate daptomycin pharmacokinetics in critically ill patients with suspected or verified bacteremia with Gram-positive cocci undergoing combined continuous hemodiafiltration at a filtration rate of 35ml/kg/h and to establish a dose recommendation for continuous hemodiafiltration at a filtrate rate of 35ml/kg/h.

Detailed Description

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Conditions

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Bacteremia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Daptomycin

once daily over 5 days

Intervention Type DRUG

Eligibility Criteria

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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 C)
* Life expectancy of less than 5 days
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Medical Intensive Care Unit

Locations

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Medical Intensive Care Unit, University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Facility Contacts

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Maggiorini, Prof

Role: primary

Other Identifiers

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EK-1632

Identifier Type: -

Identifier Source: org_study_id

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