Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
Information source: Hartford Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis; Pneumonia; Pseudomonas Aeruginosa Infection
Intervention: meropenem (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Joseph Kuti Official(s) and/or principal investigator(s):
Joseph L Kuti, Pharm.D., Principal Investigator, Affiliation: Hartford Hospital
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.
Clinical Details
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 design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Population Pharmacokinetics - Total Body ClearancePopulation Pharmacokinetics - Volume of Central Compartment
Secondary outcome: SafetyPracticality of 3 Hour Prolonged Infusion Meropenem Pharmacodynamics
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. Christopher's Hospital for Children, Philadelphia, Pennsylvania,
Connecticut Children's Medical Center, Hartford, Connecticut, Riley Hospital for Children,
Indianapolis, Indiana, Nationwide Hospital for Children, Columbus, Ohio, and Children's
Medical Center, Dallas, Texas). Cystic Fibrosis children (age 6-17 years) admitted to one
of these enrolling sites with an acute exacerbation of his or her pulmonary infection who
require antibiotic therapy with meropenem will be eligible. Meropenem will be administered
as a 3 hour prolonged infusion and blood concentrations will be measured to determine the
population pharmacokinetics in 30 patients, the safety of prolonged infusion meropenem, and
the practicality as measured be treatment burden using a questionaire. The population
pharmacokinetic model developed will be utilized to determine the optimal dose of meropenem
to administer to children with Cystic Fibrosis, and define an exposure response relationship
for the drug in this population.
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Cystic Fibrosis
- Hospitalized with acute pulmonary exacerbation
- Caused by Pseudomonas aeruginosa or other bacteria against which meropenem would be
an appropriate antibiotic treatment
Exclusion Criteria:
- 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
Locations and Contacts
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, Colubmus, Ohio 43205, United States
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania 19134, United States
Children's Medical Center, Dallas, Texas 75235, United States
Additional Information
Starting date: February 2012
Last updated: March 26, 2015
|
