Antibiotic Nephrotoxicity in Adult Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02489955
• Other study ID #: RM14/11283
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2015
• Last updated: July 2, 2015
• Start date: February 2015

Study information

• Verified date: July 2015
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: Giles Fitch
• Email: giles.fitch[@]nhs.net
• Is FDA regulated: No
• Health authority: HRA: Health Research Authority UK
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of CF*

• Able to give written informed consent

• Pulmonary exacerbation requiring IV tobramycin, amikacin or colistin based on the decision of the treating physician

Exclusion Criteria:

• Known allergy or adverse reaction to proposed antibiotic (tobramycin, amikacin or colistin)

• Pregnancy (if found to be pregnant during the study the participant will be immediately withdrawn)

• Continuation of nebulised aminoglycoside or colistin during IV treatment

• Use or intended use of NSAIDS

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Amikacin

• Tobramycin

• Colomycin

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve' (AUC) of tobramycin		Days 1, 8, 14, 28	No
Primary	Area Under the Curve' (AUC) of Amikacin or Colomycin		Days 1, 8, 14, 28	No