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
Phase 1
- 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).
- Registration Number
- EUCTR2005-003609-96-AT
- Lead Sponsor
- Medical University, Dpt. Internal Medicin, Division of General Internal Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
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
Lacking indication / contraindication for bronchoalveolar lavage
Lacking indication / contraindication for lipid-formulated amphotericin B
Lacking consent
Pregnancy
Age below 18 years
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>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<br>Concentration of lipid-formulated Amphotericin B in plasma<br>Penetration of lipid-formulated Amphotericin B (AmBisome, Amphocil, Abelcet) into the lung (C elf/C plasma)
- Secondary Outcome Measures
Name Time Method