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

• Sponsor: University of Zurich (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01212432
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief Summary

Daptomycin kinetics in CRRT

• Trial with medicinal product

Condition or Disease	Intervention/Treatment	Phase
Gram-Positive Bacterial Infections	Drug: Daptomycin	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2009
• Anticipated Primary Completion Date: Mar 1, 2010
• Anticipated Study Completion Date: Mar 1, 2010

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics [2011]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Zurich		Switzerland

Sponsors and Collaborators

• University of Zurich

Investigators

• Study Director: 01 Studienregister MasterAdmins, UniversitaetsSpital Zuerich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01212432
• Other Study ID Numbers: DAPTO_CH08
• First Posted: Sep 30, 2010
• Last Update Posted: Oct 18, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Gram positive infection and CRRT
• Additional relevant MeSH terms: Bacterial Infections; Gram-Positive Bacterial Infections; Daptomycin

Study Results

No Results Posted as of Oct 18, 2010