Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Finding Study
1 other identifier
interventional
15
1 country
1
Brief Summary
Daptomycin kinetics in CRRT
- Trial with medicinal product
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 29, 2010
CompletedFirst Posted
Study publicly available on registry
September 30, 2010
CompletedOctober 18, 2010
July 1, 2010
3 months
September 29, 2010
October 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics
2011
Interventions
Daptomycin kinetics in CRRT
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Zurich, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
01 Studienregister MasterAdmins
UniversitaetsSpital Zuerich
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 29, 2010
First Posted
September 30, 2010
Study Start
December 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
October 18, 2010
Record last verified: 2010-07