Status:
TERMINATED
Pharmacokinetic Study of Extended Infusion Meropenem in Adult Cystic Fibrosis Patients
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Sunnybrook Health Sciences Centre
University of Toronto
Conditions:
Cystic Fibrosis Pulmonary Exacerbation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Meropenem is an intravenous antibiotic commonly used to treat acute exacerbation of respiratory infections in cystic fibrosis. The research study aims to determine if a different method of infusing th...
Detailed Description
Meropenem plays a crucial role in the treatment of pulmonary exacerbations in cystic fibrosis patients, because it has activity against both P. aeruginosa and B. cepacia, two of the most problematic p...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01158937
Start Date
May 1 2010
End Date
January 1 2014
Last Update
May 21 2015
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8