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PHARMAKOKINETIK VON KOLLOIDALEM AMPHOTERICIN B BEI KRITISCH KRANKEN MIT EINGESCHRÄNKTER LEBERFUNKTION (Pharmacokinetics of colloidal Amphotericin B in critically ill Patients with hepatic impairment)

PHARMAKOKINETIK VON KOLLOIDALEM AMPHOTERICIN B BEI KRITISCH KRANKEN MIT EINGESCHRÄNKTER LEBERFUNKTION (Pharmacokinetics of colloidal Amphotericin B in critically ill Patients with hepatic impairment)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-000266-21-AT
Enrollment
16
Registered
2007-06-19
Start date
2007-07-19
Completion date
Unknown
Last updated
2015-07-10

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

Conditions

Plasma concentrations of colloidal Amphotericin B will be measured in critically ill Patients with hepatic impairment and with normal liver function, both requiring treatment with Amphocil, to determine the effect of liver impairment on the pharmacokinetics of colloidal Amphotericin B

Interventions

Trade Name: Amphocil Product Name: Amphocil Product Code: ABCD Pharmaceutical Form: Concentrate for solution for infusion

Sponsors

Medical University, Dpt. Internal Medicine, Div. of General Internal Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Indication for treatment with Amphocil (colloidal Amphotericin B) • proven or probable invasiv mycosis • renal insufficiency at the begin of therapy (serum-Creatinin > 1,5 mg/dl and under renal replacement therapy, respectively) • Aggravation of the renal function under the treatment with Amphotericin B deoxycholate • concomittant nephrotoxic medication (e.g. Aminoglykoside, Glycopeptide or Cyclosporin A) • Bilirubin 10 mg/dl (cholestatic liver failure) at the beginning of therapy with colloidal Amphotericin B • Bilirubin increase (> 10 mg/dl) by cholestatic liver failure under therapy with colloidal Amphotericin B (under steady-state) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • lacking indication/contraindication for colloidal Amphotericin B • Age 1.28 and < 10 mg/dl

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine plasma concentrations of colloidal Amphotericin B in critically ill patients with liver impairment compared to critically ill patients with normal liver function;Secondary Objective: to detect an effect of liver impairment on the pharmacokinetics of colloidal amphotericin b;Primary end point(s): * Plasma concentrations of colloidal Amphotericin B in patients with hepatic impairment * Plasma concentrations of colloidal Amphotericin B in patients with normal liver function—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026