Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01171547

Enrollment

Registered

2010-07-28

Start date

2010-02-28

Completion date

Unknown

Last updated

2010-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia

Keywords

pharmacokinetics

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.

Interventions

DRUGDaptomycin

once daily over 5 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Determination of daptomycin plasmaconcentrations and pharmacokinetics in 15 patients with gram positive infection undergoing CRRT do determine adequate dosing.	PK on days 1, 3, and 5	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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026