Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis (CRITIC) - a Randomised Pharmacokinetic Comparison of Tobramycin in CF - Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis CRITIC-1

Phase 1

• Conditions: Cystic fibrosis

• Registration Number: EUCTR2010-023030-23-GB
• Lead Sponsor: The Univeristy of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-23
• Study Completion: 2012-12-30
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

i) Diagnosis of CF (defined as clinical features of CF plus a positive sweat test OR the presence of 2 genes known to be associated with CF disease. ii) Infection with P. aeruginosa (chronic or intermittent) iii) Patient or parent / legal guardian able to give informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

i) Previous episode of acute kidney injury ii) Solid organ transplantation iii) Evidence of impaired renal function (raised serum creatinine above the normal range for age) iv) Once daily aminoglycoside unsuitable because of hypersensitivity or previous high trough levels on once daily dosing. v) Pregnancy

Study & Design

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