A Phase 4 interventional study of Tobramycin time of administration in Cystic Fibrosis, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2015-06-23.
Sponsored by University of Nottingham · Phase 4, Interventional, and Treatment
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 18 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Administration of tobramycin once daily dose in the morning
Other: Tobramycin time of administration
Evening dose of tobramycin once daily
Other: Tobramycin time of administration
Random allocation to time of day of administration of tobramycin
Renal Elimination Rate Constant of Tobramycin
Time frame: Days 1, 8 and 14
Weight
Time frame: Day 1, 8, 14
Pulmonary Function
Time frame: Day 1, 8, 14
Urinary Biomarkers
NAG, NGAL, IL-18, KIM1, Cystatin C
Time frame: Days 1 and 14
Serum biomarkers
Serum creatinine Serum Cystatin C Estimated GFR
Time frame: Days 1 & 14
Serum Electrolytes
Serum Potassium and Magnesium
Time frame: Days 1 & 14
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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University of Nottingham