Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
An Open Label Study to Assess the Population Pharmacokinetics, Safety, and Practicality of Administering Meropenem as a Prolonged Infusion to Cystic Fibrosis Children Admitted With an Acute Pulmonary Exacerbation
1 other identifier
interventional
30
1 country
7
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 exacerbation. Safety and practicality of administering meropenem as a 3 hour infusion will be measured.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2012
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2011
CompletedFirst Posted
Study publicly available on registry
September 7, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
March 27, 2015
CompletedMarch 20, 2018
February 1, 2018
1.9 years
September 2, 2011
March 17, 2015
February 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Population Pharmacokinetics - Total Body Clearance
Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's total body clearance.
8 hour dosing interval after 3rd meropenem dose
Population Pharmacokinetics - Volume of Central Compartment
Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's volume of the central compartment.
During 8 hour dosing interval after 3rd meropenem dose
Secondary Outcomes (3)
Safety
14-21 days
Practicality of 3 Hour Prolonged Infusion
14-21 days
Meropenem Pharmacodynamics
14-21 days
Study Arms (1)
Meropenem 3 hour prolonged infusion
EXPERIMENTALAll 30 participants will receive meropenem as a 3 hour infusion.
Interventions
meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joseph Kutilead
- Thrasher Research Fundcollaborator
Study Sites (7)
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Columbia University Medical Center Children's Hospital
New York, New York, 10032, United States
University of North Carolina, North Carolina Children's Hospital
Chapel Hill, North Carolina, 27514, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
Children's Medical Center
Dallas, Texas, 75235, United States
Related Publications (1)
Pettit RS, Neu N, Cies JJ, Lapin C, Muhlebach MS, Novak KJ, Nguyen ST, Saiman L, Nicolau DP, Kuti JL. Population pharmacokinetics of meropenem administered as a prolonged infusion in children with cystic fibrosis. J Antimicrob Chemother. 2016 Jan;71(1):189-95. doi: 10.1093/jac/dkv289. Epub 2015 Sep 27.
PMID: 26416780DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joseph L. Kuti, Pharm.D.
- Organization
- Hartford Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph L Kuti, Pharm.D.
Hartford Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Director, Center for Anti-Infective Research and Development
Study Record Dates
First Submitted
September 2, 2011
First Posted
September 7, 2011
Study Start
February 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
March 20, 2018
Results First Posted
March 27, 2015
Record last verified: 2018-02