Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration

NCT01171547 | Unknown Phase 2 DMC

• 1 other identifier: EK-1632
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacteremia

Keywords

pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Determination of daptomycin plasmaconcentrations and pharmacokinetics in 15 patients with gram positive infection undergoing CRRT do determine adequate dosing.

  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.

  PK on days 1, 3, and 5

Interventions

Daptomycin DRUG

once daily over 5 days

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 C)
• Life expectancy of less than 5 days

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Medical Intensive Care Unit, University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Bacteremia

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 28, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2010
• Last Updated: July 28, 2010

Record last verified: 2010-07

Locations

CH (1)