Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children

Condition(s) targeted: Cystic Fibrosis; Pneumonia; Pseudomonas Aeruginosa Infection

Intervention: meropenem (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Joseph Kuti

Official(s) and/or principal investigator(s):
Joseph L Kuti, Pharm.D., Principal Investigator, Affiliation: Hartford Hospital

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.

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:

Meropenem Blood Concentrations

Population Pharmacokinetics - Total Body Clearance

Population Pharmacokinetics - Volume of Distribution

Secondary outcome:

Safety

Practicality of 3 Hour Prolonged Infusion

Meropenem Pharmacodynamics

Detailed description: This study will be conducted at 3 pediatric hospitals in the United States (Columbia University Medical Center, New York, NY; University of North Carolina, Chapel Hill, NC; St. Christopher's Hospital for Children, Philadelphia, PA). 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.

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

Columbia University Medical Center Children's Hospital, New York, New York 10032, United States; Recruiting
Lisa Saiman, MD, MPH, Phone: 212-305-9446, Email: ls5@columbia.edu
Lisa Saiman, MD, MPH, Principal Investigator

University of North Carolina, North Carolina Children's Hospital, Chapel Hill, North Carolina 27514, United States; Recruiting
Marianne Muhlebach, MD, Phone: 919-966-1055, Email: marianne_muhlebach@med.unc.edu
Marianne Muhlebach, MD, Principal Investigator

St. Christopher's Hospital for Children, Philadelphia, Pennsylvania 19134, United States; Recruiting
Jeffrey J Cies, Pharm.D., Phone: 215-427-5176, Email: jeffrey.cies@tenethealth.com
Jeffrey J Cies, Pharm.D., Principal Investigator

Starting date: February 2012
Last updated: April 6, 2012