Antibiotic nephrotoxicity in Adult Patients with Cystic Fibrosis
Research type
Research Study
Full title
Prospective randomised trial of ‘area under the curve’ (AUC) dosing strategy for intravenous tobramycin versus standard trough dosing for pulmonary exacerbations in adult patients with cystic fibrosis (CF).
IRAS ID
155607
Contact name
Giles Fitch
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
Adult patients with cystic fibrosis (CF) are treated with high dose antibiotics to reduce the long term damage to their lungs from infection. This would typically be with a two week course of intravenous antibiotics each time they have a chest infection (typically three to four times a year).
The most effective and commonly used antibiotic in most cases is tobramycin. If this cannot be used because of previous side effects, allergy or a resistant infection then colomycin or amikacin are usually used. Each of these antibiotics are known to be toxic to both the kidneys and ear. As patients are living longer (into their forties), the total amount of these antibiotics they are receiving over their lifetime is increasing. This is now leading to increased complications such as kidney damage and hearing loss. Because of this we need to look at methods to accurately quantify damage and reduce potential kidney and hearing damage.
We intend to quantify kidney damage by measuring new protein markers within the urine and blood that signify kidney damage before more conventional and currently available methods are able to.
In those patients treated with intravenous tobramycin we will also look at an alternative method used to calculate the most appropriate dose of antibiotic for each participant. This dosing method is called ‘area under the curve or AUC’ dose monitoring. This method currently in clinical use in other countries is thought to more accurately reflect the most appropriate dose for each participant and thus reduce the chance of kidney and hearing problems.
This ‘AUC’ method requires two rather than one dose level to be checked each time a dose calculation is made. Participants receiving tobramycin will be randomised to receive dosing by this method or our currently used method of ‘trough’ monitoring.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
14/YH/1268
Date of REC Opinion
8 Jan 2015
REC opinion
Further Information Favourable Opinion