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Circadian Rhythm In Tobramycin Elimination In Cystic Fibrosis

Information source: University of Nottingham
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis

Intervention: Tobramycin time of administration (Other)

Phase: Phase 4

Status: Completed

Sponsored by: University of Nottingham

Official(s) and/or principal investigator(s):
Alan Smyth, Principal Investigator, Affiliation: University of Nottingham


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.

Clinical Details

Official title: Circadian Rhythm In Tobramycin Elimination In Cystic Fibrosis (CRITIC) A Randomized Pharmacokinetic Comparison of Tobramycin in Cystic Fibrosis

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Renal Elimination Rate Constant of Tobramycin

Secondary outcome:


Pulmonary Function

Urinary Biomarkers

Serum biomarkers

Serum Electrolytes


Minimum age: 5 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- 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 Criteria:

- 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

Locations and Contacts

Nottingham University Hospitals NHS Trust, Nottingham, Nottinghamshire NG7 2UH, United Kingdom
Additional Information

Starting date: May 2011
Last updated: June 22, 2015

Page last updated: August 23, 2015

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