Phase 4
N=30
Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
Cystic Fibrosis · Pneumonia · Pseudomonas Aeruginosa Infection
Bottom Line
View on ClinicalTrials.gov: NCT01429259 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Mar 2015
Primary outcome: Primary: Population Pharmacokinetics - Total Body Clearance — 0.36 L/hr/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- meropenem (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Joseph Kuti
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Population Pharmacokinetics - Total Body Clearance |
0.36 | — |
| PRIMARY Population Pharmacokinetics - Volume of Central Compartment |
0.21 | — |
| SECONDARY Safety |
— | — |
| SECONDARY Practicality of 3 Hour Prolonged Infusion |
— | — |
| SECONDARY Meropenem Pharmacodynamics |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01429259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.