Chronic pulmonary aspergillosis
Conditions
Brief summary
The amount of AmBisome deposited in the lungs measured through single-photon emission computed tomography (SPECT/CT)., The amount of AmBisome in the lungs compared to the blood concentrations to understand drug absorption and distribution, The most appropriate dose of nebulised AmBisome based on pulmonary deposition and pharmacokinetics.
Detailed description
A validated GMP-grade procedure for Technetium-99m labelled AmBisome., Number of adverse reactions associated with nebulised AmBisome, including respiratory symptoms, effects on pulmonary function and (S)AEs., Assessment of PROs using a validated PRO instruments (TSQM) to assess side effects, treatment convenience and global satisfaction with therapy.
Interventions
DRUGAmBisome liposomale amfotericine B 50 mg
DRUGTECHNETIUM (99MTC) PERTECHNETATE
Sponsors
Radboud universitair medisch centrum Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The amount of AmBisome deposited in the lungs measured through single-photon emission computed tomography (SPECT/CT)., The amount of AmBisome in the lungs compared to the blood concentrations to understand drug absorption and distribution, The most appropriate dose of nebulised AmBisome based on pulmonary deposition and pharmacokinetics. | — |
Secondary
| Measure | Time frame |
|---|---|
| A validated GMP-grade procedure for Technetium-99m labelled AmBisome., Number of adverse reactions associated with nebulised AmBisome, including respiratory symptoms, effects on pulmonary function and (S)AEs., Assessment of PROs using a validated PRO instruments (TSQM) to assess side effects, treatment convenience and global satisfaction with therapy. | — |
Countries
Netherlands
Outcome results
None listed