Circadian Influence on Renal Clearance of Aminoglycosides in cystic fibrosis patients - CIRCA

• Conditions: Repeated or extended dosing of aminoglycosides may cause damage to the proximal tubuli, resulting in renal impairment. Renal impairment affects up to 40 % of adult CF patients, measured after estimation using an appropriate formula. The true number is probably even greater.

• Registration Number: EUCTR2008-005110-41-NL
• Lead Sponsor: not applicable

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified