Amphotericin B Spiegel in bronchoalveolären Lavagen (Epithelial Lining Fluid) unter Behandlung mit lipidformuliertem Amphotericin B (Amphotericin B levels in broncho-alveolar lavage [epithelial lining fluid] during treatment with lipid-formulated amphotericin B) - Amphotericn B in epithelial lining fluid

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003609-96-AT

Enrollment

Registered

2005-09-06

Start date

2005-09-07

Completion date

Unknown

Last updated

2020-11-30

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

Conditions

Plasma and ELF concentrations of lipidformulatied amphotericin b will be measured in patients requiring treatment with lipid-formulated amphotericin B for fungal pneumonia (proven or suspected).

Interventions

Trade Name: Amphocil, AmBisome, Abelcet Product Name: Amphocil, AmBisome, Abelcet Product Code: ABCD / LAMB / ABLC Pharmaceutical Form: Concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Indication for treatment with lipid-formulated amphotericin B Indication for bronchoalveolar lavage Proven or supected invasive mycosis Renal insufficiency at the begin of the treatment Aggravation of the renal function under the treatment with Amphotericin deoxycholate Concomitant nephrotoxic medication Are the trial subjects under 18? 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 bronchoalveolar lavage Lacking indication / contraindication for lipid-formulated amphotericin B Lacking consent Pregnancy Age below 18 years

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine concentrations of lipid-formulated amphotericin B in the epithelial lining fluid (ELF) compared to the plasma concentration of lipid-formulated amphotericin B in patients with fungal pneumonia ;Secondary Objective: To determine lung penetration of lipid-formulated amphotericin B administered in patients with fungal pneumonia. To detect relevant differences in lung penetration between the three amphotericin B lipid-formualtions ;Primary end point(s): Concentration of lipid-formulated Amphotericin B in epithelial lining fluid Concentration of lipid-formulated Amphotericin B in plasma Penetration of lipid-formulated Amphotericin B (AmBisome, Amphocil, Abelcet) into the lung (C elf/C plasma)	—

Measure

Time frame

Main Objective: To determine concentrations of lipid-formulated amphotericin B in the epithelial lining fluid (ELF) compared to the plasma concentration of lipid-formulated amphotericin B in patients with fungal pneumonia ;Secondary Objective: To determine lung penetration of lipid-formulated amphotericin B administered in patients with fungal pneumonia. To detect relevant differences in lung penetration between the three amphotericin B lipid-formualtions ;Primary end point(s): Concentration of lipid-formulated Amphotericin B in epithelial lining fluid Concentration of lipid-formulated Amphotericin B in plasma Penetration of lipid-formulated Amphotericin B (AmBisome, Amphocil, Abelcet) into the lung (C elf/C plasma)

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Countries

Austria

Outcome results

None listed

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