Cystic Fibrosis Clinical Trial
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
Verified date | February 2018 |
Source | Hartford Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina, North Carolina Children's Hospital | Chapel Hill | North Carolina |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Children's Medical Center | Dallas | Texas |
United States | Connecticut Children's Medical Center | Hartford | Connecticut |
United States | Riley Hospital for Children | Indianapolis | Indiana |
United States | Columbia University Medical Center Children's Hospital | New York | New York |
United States | St. Christopher's Hospital for Children | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Joseph Kuti | Thrasher Research Fund |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Population Pharmacokinetics - Total Body Clearance | Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's total body clearance. | 8 hour dosing interval after 3rd meropenem dose | |
Primary | Population Pharmacokinetics - Volume of Central Compartment | Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's volume of the central compartment. | During 8 hour dosing interval after 3rd meropenem dose | |
Secondary | Safety | 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. | 14-21 days | |
Secondary | Practicality of 3 Hour Prolonged Infusion | 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. | 14-21 days | |
Secondary | Meropenem Pharmacodynamics | 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). | 14-21 days |
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