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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01429259
Recruitment Status : Completed
First Posted : September 7, 2011
Results First Posted : March 27, 2015
Last Update Posted : March 20, 2018
Thrasher Research Fund
Information provided by (Responsible Party):
Joseph Kuti, Hartford Hospital

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Pneumonia Pseudomonas Aeruginosa Infection Drug: meropenem Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Meropenem

Arm Intervention/treatment
Experimental: Meropenem 3 hour prolonged infusion
All 30 participants will receive meropenem as a 3 hour infusion.
Drug: meropenem
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

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01429259

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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
Sponsors and Collaborators
Joseph Kuti
Thrasher Research Fund
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Principal Investigator: Joseph L Kuti, Pharm.D. Hartford Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Joseph Kuti, Associate Director, Center for Anti-Infective Research and Development, Hartford Hospital Identifier: NCT01429259    
Other Study ID Numbers: KUTI003498HE
First Posted: September 7, 2011    Key Record Dates
Results First Posted: March 27, 2015
Last Update Posted: March 20, 2018
Last Verified: February 2018
Keywords provided by Joseph Kuti, Hartford Hospital:
Cystic Fibrosis
Acute Pulmonary Exacerbations
Pseudomonas aeruginosa
Additional relevant MeSH terms:
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Pseudomonas Infections
Cystic Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents