Antibiotic Nephrotoxicity in Adult Patients With Cystic Fibrosis
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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, the
investigators need to look at methods to accurately quantify damage and reduce potential
kidney and hearing damage.
The investigators 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 the
investigators 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 the investigators' currently used
method of 'trough' monitoring.