Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
|ClinicalTrials.gov Identifier: NCT01429259|
Recruitment Status : Completed
First Posted : September 7, 2011
Results First Posted : March 27, 2015
Last Update Posted : March 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Pneumonia Pseudomonas Aeruginosa Infection||Drug: meropenem||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Experimental: Meropenem 3 hour prolonged infusion
All 30 participants will receive meropenem as a 3 hour infusion.
meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion.
Other Name: Merrem
- Population Pharmacokinetics - Total Body Clearance [ Time Frame: 8 hour dosing interval after 3rd meropenem dose ]Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's total body clearance.
- Population Pharmacokinetics - Volume of Central Compartment [ Time Frame: During 8 hour dosing interval after 3rd meropenem dose ]Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's volume of the central compartment.
- Safety [ Time Frame: 14-21 days ]This will be an intention to treat analysis of all 30 participants receiving meropenem as a 3 hour prolonged infusion. Participants will be monitored for any sign of symptom of adverse events throughout the course of the study. An adverse event will be defined as any pathologic or unintended change in the structure (signs), function (symptoms), or chemistry (laboratory values) of the body associated with the use of the study drug.
- Practicality of 3 Hour Prolonged Infusion [ Time Frame: 14-21 days ]This will be an intention to treat analysis of all 30 participants receiving meropenem as a 3 hour prolonged infusion. The Cystic Fibrosis Questionnaire-Revised (CFQ-R) will be utilized to assess patient or parent assessments of the burden of the prolonged infusion treatment. The CFQ-R will be administered at the beginning of the study and then within 7 days after completion of meropenem therapy.
- Meropenem Pharmacodynamics [ Time Frame: 14-21 days ]Meropenem exposures defined from the population model for each participant will be analyzed as a function of the isolated pathogens meropenem minimum inhibitory concentration (MIC) to define the exposure of meropenem associated with an absolute and relative percent change in the Forced Expiratory Volume (FEV1).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429259
|United States, Connecticut|
|Connecticut Children's Medical Center|
|Hartford, Connecticut, United States, 06106|
|United States, Indiana|
|Riley Hospital for Children|
|Indianapolis, Indiana, United States, 46202|
|United States, New York|
|Columbia University Medical Center Children's Hospital|
|New York, New York, United States, 10032|
|United States, North Carolina|
|University of North Carolina, North Carolina Children's Hospital|
|Chapel Hill, North Carolina, United States, 27514|
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|United States, Pennsylvania|
|St. Christopher's Hospital for Children|
|Philadelphia, Pennsylvania, United States, 19134|
|United States, Texas|
|Children's Medical Center|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Joseph L Kuti, Pharm.D.||Hartford Hospital|