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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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12 December 2020 |
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Main ID: |
NCT02504827 |
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Date of registration:
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20/07/2015 |
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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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Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis
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Scientific title:
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Steady-state Pharmacokinetics of Ceftazidime/Avibactam in CF |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02504827 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Paul Beringer, PharmD |
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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 Southern California |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of CF based on positive sweat chloride or know CF mutation
- Age > 17 years
- Able to spontaneously expectorate sputum
Exclusion Criteria:
- Any clinically significant laboratory abnormality
- Presence of an ongoing acute pulmonary exacerbation
- Pregnancy
- Serious past allergy to a beta-lactam antibiotic
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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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: Ceftazidime/avibactam
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Primary Outcome(s)
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Peak Plasma Concentration (Cmax)
[Time Frame: 8 hours]
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Peak Sputum Concentration
[Time Frame: 8 hours]
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Secondary ID(s)
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APP-15-01273
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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