Status:
COMPLETED
Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
Lead Sponsor:
Joseph Kuti
Collaborating Sponsors:
Thrasher Research Fund
Conditions:
Cystic Fibrosis
Pneumonia
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
This study will be conducted at 7 pediatric hospitals in the United States (Columbia University Medical Center, New York, New York; University of North Carolina, Chapel Hill, North Carolina; St. Chris...
Eligibility Criteria
Inclusion
- Cystic Fibrosis
- Hospitalized with acute pulmonary exacerbation
- Caused by Pseudomonas aeruginosa or other bacteria against which meropenem would be an appropriate antibiotic treatment
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01429259
Start Date
February 1 2012
End Date
January 1 2014
Last Update
March 20 2018
Active Locations (7)
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1
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
2
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
3
Columbia University Medical Center Children's Hospital
New York, New York, United States, 10032
4
University of North Carolina, North Carolina Children's Hospital
Chapel Hill, North Carolina, United States, 27514