Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
Completed · Phase 4
Conditions studied: Cystic Fibrosis, Pneumonia, Pseudomonas Aeruginosa Infection
In brief
This study will determine the concentrations of the antibiotic meropenem when administered as a 3 hour prolonged infusion in children with cystic fibrosis who are hospitalized with an acute pulmonary exacerbation. Safety and practicality of administering meropenem as a 3 hour infusion will be measured.
Key facts
- Study ID
- NCT01429259
- Run by
- Joseph Kuti
- People needed
- 30
- Starts
- 2012-02-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2018-03-20
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Cystic Fibrosis
- Hospitalized with acute pulmonary exacerbation
- Caused by Pseudomonas aeruginosa or other bacteria against which meropenem would be an appropriate antibiotic treatment
You may not qualify if…
- Known allergy to meropenem
- Require less than 3 days of meropenem in the hospital
- Require another systemic Beta-lactam antibiotic to treat a concomitant pathogen
- Known fungal or viral infection
- Females in their 2nd or 3rd trimester of pregnancy
- Moderate to severe renal dysfunction, as defined by a creatinine clearance less than 50 ml/min/1.73m2 (by use of Schwartz method)
- History of solid organ transplantation within previous 6 months
- Active or recent (within 30 days) participation in another antibiotic clinical trial
Where it is running
- Connecticut Children's Medical Center — Hartford, Connecticut, United States
- Riley Hospital for Children — Indianapolis, Indiana, United States
- Columbia University Medical Center Children's Hospital — New York, New York, United States
- University of North Carolina, North Carolina Children's Hospital — Chapel Hill, North Carolina, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- St. Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
- Children's Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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