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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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1 June 2015 |
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Main ID: |
NCT01158937 |
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Date of registration:
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07/07/2010 |
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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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Pharmacokinetic Study of Extended Infusion Meropenem in Adult Cystic Fibrosis Patients
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Scientific title:
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Pharmacokinetic Study of Extended Infusion Meropenem in Adult Cystic Fibrosis Patient With Exacerbation of Pulmonary Infection |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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2 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01158937 |
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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/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Daniel Cortes |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Michael's Hospital, Toronto |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- =18 years old,
- currently experiencing new or exacerbation of active pulmonary infection as evidenced
by increased coughing, sputum production, wheezing, white blood count and/or fever,
- requires meropenem for treatment,
- recent sputum culture positive for P. aeruginosa and/or B. cepacia at a prior visit,
- be able to provide written informed consent.
Exclusion Criteria:
- hypersensitivity and/or intolerance to meropenem,
- history of seizures,
- current use of valproic acid,
- significant psychiatric illness,
- contraindication to insertion of a venous catheter,
- worsening of clinical status requiring admission to intensive care unit (ICU),
- creatinine clearance =50 ml/min,
- significant cystic fibrosis-related liver dysfunction characterized by portal
hypertension and cirrhosis
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 Pulmonary Exacerbation
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Intervention(s)
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Drug: Meropenem Infusion
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Primary Outcome(s)
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Pharmacokinetic profile of extended infusion meropenem in Cystic Fibrosis
[Time Frame: Two x eight hour pharmacokinetic monitoring periods (carried over 2 days).]
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Secondary ID(s)
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REB#08-316
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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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