At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 30 enrolled
Drug / intervention
meropenemdrug
Likely dose
meropenem 40mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating meropenem for Cystic Fibrosis and 2 related conditions. Completed, enrolled 30 participants across 7 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis, Pneumonia, Pseudomonas Aeruginosa Infection
CountriesUnited States
CollaboratorsThrasher Research Fund
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2011
Enrollment StartFeb 2012
Primary CompletionJan 2014
TodayJul 2026
First PostedSep 7, 2011
Enrollment StartFeb 1, 2012
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.8 years ago
Interventions
meropenemdrug
meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion.