Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
| Status: | Completed |
|---|---|
| Conditions: | Pneumonia, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 6 - 17 |
| Updated: | 4/17/2018 |
| Start Date: | February 2012 |
| End Date: | January 2014 |
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
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.
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.
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.
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.
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
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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