Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Zurich.
Recruitment status was Recruiting
Information provided by:
University of Zurich
First received: July 22, 2010
Last updated: July 27, 2010
Last verified: July 2010
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.
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
||Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Find Study
Primary Outcome Measures:
- Determination of daptomycin plasmaconcentrations and pharmacokinetics in 15 patients with gram positive infection undergoing CRRT do determine adequate dosing. [ Time Frame: PK on days 1, 3, and 5 ] [ Designated as safety issue: No ]
15 patients are devided in 3 cohorts of 5 patients each. PK data(measured on day 1, 3 and 5) of the first 5 patients receiving daptomycin 6mg/kg/day during 5 consecutive days additionally to standard antibiotic treatment are compared with PK data of daptomycin 6mg/kg/day in healthy volunteers and dose is adapted in the next 5 patients based on these results. The same is done for the last 5 patients.
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||February 2010 (Final data collection date for primary outcome measure)
once daily over 5 days
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171547
|Medical Intensive Care Unit, University Hospital Zurich
|Zurich, Switzerland, 8091 |
|Contact: Maggiorini, Prof firstname.lastname@example.org |
University of Zurich
No publications provided
||Prof. Marco Maggiorini, MD, Medical Intensive Care Unit
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 22, 2010
||July 27, 2010
Keywords provided by University of Zurich:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 27, 2015