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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01429259
• Date of registration: 02/09/2011
• Prospective Registration: Yes
• Primary sponsor: Joseph Kuti
• Public title: Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
• Scientific 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
• Date of first enrolment: February 2012
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01429259
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Joseph L Kuti, Pharm.D.
• Affiliation: Hartford Hospital

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pneumonia

Cystic Fibrosis

Pseudomonas Aeruginosa Infection

Intervention(s)

Drug: meropenem

Primary Outcome(s)

Population Pharmacokinetics - Volume of Central Compartment [Time Frame: During 8 hour dosing interval after 3rd meropenem dose]

Population Pharmacokinetics - Total Body Clearance [Time Frame: 8 hour dosing interval after 3rd meropenem dose]

Secondary Outcome(s)

Safety [Time Frame: 14-21 days]

Meropenem Pharmacodynamics [Time Frame: 14-21 days]

Practicality of 3 Hour Prolonged Infusion [Time Frame: 14-21 days]

Secondary ID(s)

KUTI003498HE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Thrasher Research Fund

Results

• Results available: Yes
• Date Posted: 27/03/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01429259