EUCTR2008-005110-41-NLActive, not recruitingNot Applicable
Circadian Influence on Renal Clearance of Aminoglycosides in cystic fibrosis patients - CIRCA
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- not applicable
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Inclusion criteria :
- •-Age: = 18 years
- •-a diagnosis of cystic fibrosis (ie, sweat chloride _60 mmol/L or a genotype associated with cystic fibrosis)
- •-chronic infection with Pseudomonas aeruginosa with the most recently isolated organism showing sensitivity to tobramycin.
- •-Pulmonary exacerbation as defined by Fuchs and colleagues
- •Are the trial subjects under 18? no
- •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) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •-use of nephrotoxic drugs (NSAID´s, furosemide, vancomycin)
- •-allergy for aminoglycosides
- •-granulocytopenia (<1,0 x 109/L)
- •-pregnancy
- •-calculated GFR < 40 ml/min
- •-pre-existing hearing impairment (_20 dB hearing level at any two frequencies between 2kHz and 8 kHz on the standard audiogram)
Investigators
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