Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis CRITIC-1
Research type
Research Study
Full title
Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis (CRITIC) - a Randomised Pharmacokinetic Comparison of Tobramycin in CF
IRAS ID
17879
Contact name
Alan Smyth
Eudract number
2010-023030-23
Clinicaltrials.gov Identifier
Research 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 treated with antibiotics (such as tobramycin) into the vein (termed ??intravenous antibiotics?Â). This has without doubt improved survival. However, all treatments have side effects. Tobramycin can cause kidney damage. We have preliminary data that suggests that administering tobramycin in the morning may be safer for the kidneys than administering it in the evening. We plan to approach children and adults with cystic fibrosis whose doctors have decided to administer a course of intravenous tobramycin. We will randomly allocate them to receive it at either 0800h or 2000h. We will measure the rate at which the body eliminates tobramycin from the bloodstream, by measuring the amount of tobramycin in the blood stream after administering the antibiotic. For each patient the study will last for the duration of the course of antibiotics. This is decided by the doctor looking after the patient (rather than the researcher), and would typically be 14 days. We will also measure substances in the blood and urine (??biomarkers?Â) which are sensitive indicators of low levels of kidney injury. We will monitor lung function and lung bacteria in both the groups to ensure that the patients in both groups improve by the same amount.If our preliminary data are proved correct, this research will allow us to improve the safety profile of tobramycin, one of the most widely prescribed drugs in cystic fibrosis.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
10/H0408/98
Date of REC Opinion
2 Dec 2010
REC opinion
Favourable Opinion