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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: |
NCT01207245 |
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Date of registration:
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21/09/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Circadian Rhythm In Tobramycin Elimination In Cystic Fibrosis
CRITIC |
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Scientific title:
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Circadian Rhythm In Tobramycin Elimination In Cystic Fibrosis (CRITIC) A Randomized Pharmacokinetic Comparison of Tobramycin in Cystic Fibrosis |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01207245 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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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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Alan Smyth |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Nottingham |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of cystic fibrosis (CF) (defined as clinical features of CF plus a positive
sweat test OR the presence of 2 genes known to be associated with CF disease)
- Males or female 5 years and older
- Treating doctor has decided to commence a course of tobramycin
- Patient or parent / legal guardian able to give informed consent
Exclusion Criteria:
- Previous episode of acute kidney injury
- Solid organ transplantation
- Evidence of impaired renal function (raised serum creatinine above the normal range
for age)
- Once daily aminoglycoside unsuitable because of hypersensitivity or previous high
trough levels on once daily dosing.
- Pregnancy
Age minimum:
5 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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Other: Tobramycin time of administration
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Primary Outcome(s)
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Renal Elimination Rate Constant of Tobramycin
[Time Frame: Days 1, 8 and 14]
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Secondary Outcome(s)
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Serum biomarkers
[Time Frame: Days 1 & 14]
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Serum Electrolytes
[Time Frame: Days 1 & 14]
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Urinary Biomarkers
[Time Frame: Days 1 and 14]
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Pulmonary Function
[Time Frame: Day 1, 8, 14]
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Weight
[Time Frame: Day 1, 8, 14]
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Secondary ID(s)
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10076
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NIHR RfPB PB-PG-1207-15025
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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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