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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 August 2015 |
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Main ID: |
NCT02489955 |
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Date of registration:
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18/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Antibiotic Nephrotoxicity in Adult Patients With Cystic Fibrosis
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Scientific title:
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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) |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02489955 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Giles Fitch |
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Address:
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Telephone:
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Email:
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giles.fitch@nhs.net |
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Affiliation:
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Name:
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Giles Fitch |
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Address:
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Telephone:
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Email:
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giles.fitch@nhs.net |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Colomycin
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Drug: Tobramycin
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Drug: Amikacin
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Primary Outcome(s)
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Area Under the Curve' (AUC) of Amikacin or Colomycin
[Time Frame: Days 1, 8, 14, 28]
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Area Under the Curve' (AUC) of tobramycin
[Time Frame: Days 1, 8, 14, 28]
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Secondary ID(s)
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RM14/11283
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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