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Antibiotic Nephrotoxicity in Adult Patients With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02489955
Recruitment Status : Unknown
Verified July 2015 by The Leeds Teaching Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : July 3, 2015
Last Update Posted : July 3, 2015
Information provided by (Responsible Party):
The Leeds Teaching Hospitals NHS Trust

Brief 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Amikacin Drug: Tobramycin Drug: Colomycin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
Study Start Date : February 2015
Estimated Primary Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: AUC group Drug: Amikacin
Drug: Colomycin
Active Comparator: Trough dose monitoring Drug: Tobramycin

Primary Outcome Measures :
  1. Area Under the Curve' (AUC) of tobramycin [ Time Frame: Days 1, 8, 14, 28 ]
  2. Area Under the Curve' (AUC) of Amikacin or Colomycin [ Time Frame: Days 1, 8, 14, 28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02489955

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Contact: Giles Fitch

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United Kingdom
Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, United Kingdom
Contact: Giles Fitch   
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust

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Responsible Party: The Leeds Teaching Hospitals NHS Trust Identifier: NCT02489955     History of Changes
Other Study ID Numbers: RM14/11283
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Anti-Bacterial Agents
Anti-Infective Agents