WIRKORTKONZENTRATIONEN VON AMPHOTERICIN B FORMULIERUNGEN IN ASZITES, LIQUOR, PLEURAERGUSS, GALLE UND LIQUOR BEI KRITISCH KRANKEN (Target-site concentrations of Amphotericin B preparations in ascites, pleural effusion, bile and cerebrospinal fluid in critically ill patients) - Target-Site concentrations of AMB

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001795-37-AT

Enrollment

Registered

2007-06-21

Start date

2007-07-19

Completion date

Unknown

Last updated

2022-05-16

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

Conditions

Plasma and target-site (ascites, pleural effusion, bile and cerebrospinal fluid) concentrations of amphotericin B preparations will be measured in critically ill patients, requiring treatment with a amphotericin b preparation and requiring pleuracentesis, abdominal paracentesis, lumbar puncture or bile sampling for diagnostic or therapeutic reasons, to determine penetration of the drugs to target site.

Interventions

Trade Name: Amphocil Product Name: Amphocil Product Code: ABCD Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: AMPHOTERICIN B CAS Number: 1397893 Trade Name: AmBisome

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Treatment with an amphotericin B preparation in proven or suspected invasive mycosis. Lipid-formulated amphotericin B is given when conventional amphotericin B is contraindicated. • Indication for sampling during routine intervention (pleuracentesis, abdominal paracentesis, bile sampling or lumbar puncture) 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 amphotericin b preparations • lacking indication / contraindication for routine intervention for sample assessment • age below 18 years • lacking consent • pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: to determine concentrations of amphotericin B in plasma and at target site (ascites, pleural effusion, bile and cerebrospinal fluid). to determine target-site penetration of amphotericin B preparatations administered in critically ill patients requiring a amphotericin B preparation.;Secondary Objective: to detect potential differences in the penetration ratio between the amphotericin B preparations.;Primary end point(s): concentration of amphotericin B preparations at target site penetration of amphotericin B preparations to target site (C target-site/C plasma)	—

Measure

Time frame

Main Objective: to determine concentrations of amphotericin B in plasma and at target site (ascites, pleural effusion, bile and cerebrospinal fluid). to determine target-site penetration of amphotericin B preparatations administered in critically ill patients requiring a amphotericin B preparation.;Secondary Objective: to detect potential differences in the penetration ratio between the amphotericin B preparations.;Primary end point(s): concentration of amphotericin B preparations at target site penetration of amphotericin B preparations to target site (C target-site/C plasma)

—

Countries

Austria

Outcome results

None listed

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