Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Circadian Rhythm In Tobramycin Elimination In Cystic Fibrosis (CRITIC) A Randomized Pharmacokinetic Comparison of Tobramycin in Cystic Fibrosis
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 treated with antibiotics (such as tobramycin) into the vein (termed "intravenous antibiotics"). This has without doubt improved survival. However, all treatments have side effects. Tobramycin can cause kidney damage. The investigators have preliminary data that suggests that administering tobramycin in the morning may be safer for the kidneys than administering it in the evening.

The investigators plan to approach children and adults with cystic fibrosis whose doctors have decided to administer a course of intravenous tobramycin. The investigators will randomly allocate them to receive it at either 0800h or 2200h. The investigators 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. The investigators will also measure substances in the blood and urine ("biomarkers") which are sensitive indicators of low levels of kidney injury. The investigators 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 the preliminary data are proved correct, this research will allow investigators to improve the safety profile of tobramycin, one of the most widely prescribed drugs in cystic fibrosis.


Options:
A: Arm Label: Cohort 1 - 280 mg ARIKACE™; Type: EXPERIMENTAL; Interventions: Drug: ARIKACE™ | Arm Label: Cohort 1 - Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Cohort 2 - 560 mg ARIKACE™; Type: EXPERIMENTAL; Interventions: Drug: ARIKACE™ | Arm Label: Cohort 2 - Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: ARIKACE™; Assigned to Arm(s): Cohort 1 - 280 mg ARIKACE™, Cohort 2 - 560 mg ARIKACE™ | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Cohort 1 - Placebo, Cohort 2 - Placebo
B: Arm Label: Tobramycin 300 mg for 28 days; Type: EXPERIMENTAL; Interventions: Drug: Tobramycin solution for inhalation 300 mg | Arm Label: Tobramycin 300 mg for 56 days; Type: EXPERIMENTAL; Interventions: Drug: Tobramycin solution for inhalation 300 mg | Intervention Type: DRUG; Name: Tobramycin solution for inhalation 300 mg; Assigned to Arm(s): Tobramycin 300 mg for 28 days, Tobramycin 300 mg for 56 days
C: Arm Label: Morning dose of tobramycin; Type: ACTIVE_COMPARATOR; Interventions: Other: Tobramycin time of administration | Arm Label: Evening tobramycin; Type: ACTIVE_COMPARATOR; Interventions: Other: Tobramycin time of administration | Intervention Type: OTHER; Name: Tobramycin time of administration; Assigned to Arm(s): Evening tobramycin, Morning dose of tobramycin
D: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Arikayce™ 560 mg | Arm Label: B; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo for 560 mg | Arm Label: C; Type: ACTIVE_COMPARATOR; Interventions: Drug: Arikayce™ 70 mg | Arm Label: D; Type: ACTIVE_COMPARATOR; Interventions: Drug: Arikayce™ 140 mg | Arm Label: E; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo for 70 mg / 140 mg | Intervention Type: DRUG; Name: Arikayce™ 560 mg; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Placebo for 560 mg; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Arikayce™ 70 mg; Assigned to Arm(s): C | Intervention Type: DRUG; Name: Arikayce™ 140 mg; Assigned to Arm(s): D | Intervention Type: DRUG; Name: Placebo for 70 mg / 140 mg; Assigned to Arm(s): E

Answer: C