Pharmacokinetics of nasally administered tobramycin and colistin in Cystic Fibrosis
Completed
- Conditions
- Cystic Fibrosismucoviscidosis100386861000401810024970
- Registration Number
- NL-OMON38737
- Lead Sponsor
- HagaZiekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
1. Confirmed diagnose of Cystic Fibrosis based on genotyping or a positive sweat test
2. Age >= 18 years
3. Intravenous course of tobramycin in the past, but within the age of >= 18 years, with a creatinine value measured during that same intravenous course of tobramycin
Exclusion Criteria
1. Kidney dysfunction (defined as estimated Glomerular Filtration Rate of < 50 ml/min)
2. Liver dysfunction (defined as at least one of the liver enzymes >= 3 times the normal value)
3. Intravenous treatment with aminoglycosides or polymyxins <= 48 hours
4. Acute pulmonary exacerbation (defined by Fuchs criteria)
5. Allergy or intolerance for aminoglycosides or polymyxins
6. Recent surgery of ear, nose or sinuses (< 3 months before study entry)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetic parameters, including AUC (area under the curve), tmax (time to<br /><br>maximum concentration), Cmax (maximum plasma concentration), t1/2,el (terminal<br /><br>half-life) and F (bioavailability).</p><br>
- Secondary Outcome Measures
Name Time Method <p>• CL (total body clearance)<br /><br>• safety of the nasal irrigations with tobramycin, colistin and a combination<br /><br>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<br /><br>irrigations</p><br>