Status:
COMPLETED
Circadian Rhythm In Tobramycin Elimination In Cystic Fibrosis
Lead Sponsor:
University of Nottingham
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
5+ years
Phase:
PHASE4
Brief Summary
Cystic fibrosis is the most common inherited life limiting condition which affects children. Patients with it develop lung infections which become difficult to clear, and damage the lungs. These are t...
Eligibility Criteria
Inclusion
- Diagnosis of cystic fibrosis (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)
- Males or female 5 years and older
- Treating doctor has decided to commence a course of tobramycin
- Patient or parent / legal guardian able to give informed consent
Exclusion
- Previous episode of acute kidney injury
- Solid organ transplantation
- Evidence of impaired renal function (raised serum creatinine above the normal range for age)
- Once daily aminoglycoside unsuitable because of hypersensitivity or previous high trough levels on once daily dosing.
- Pregnancy
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01207245
Start Date
May 1 2011
End Date
June 1 2012
Last Update
June 23 2015
Active Locations (1)
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1
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH