Gedrag van nasaal toegediende tobramycine en colistine in het lichaam van patiënten met taaislijmziekte
- Conditions
- Cystic Fibrosis
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Confirmed diagnosis of Cystic Fibrosis based on genotyping or a positive sweat test;
- Age > 18 years;
Exclusion Criteria
- Kidney dysfunction (defined as estimated Glomerular Filtration Rate of < 50 ml/min);
- Liver dysfunction (defined as at least one of the following enzymes ¡Ý 3 times the normal value; aspartate aminotransferase (ASAT), alanin aminotransferase (ALAT), Gamma-glutamyltransferase (gGT), lactate dehydrogenase (LD) and alkaline phosphatase (ALP);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - AUC (area under the curve);<br /><br>- tmax (time to maximum concentration);<br /><br>- Cmax (maximum plasma concentration);<br /><br>- t1/2,el (terminal half-life);<br /><br>- F (bioavailability).
- Secondary Outcome Measures
Name Time Method - CL (total body clearance);<br /><br>- safety of the nasal irrigations with tobramycin, colistin and a combination of tobramycin and colistin, determined by systemic absorption (bioavailability);<br /><br>- adverse reactions;<br /><br>- Visual Analogue Scale (VAS) score for (in)convenience of the nasal irrigations.