NCT02048163

Intermittent Versus Continuous Infusion Meropenem in Cystic Fibrosis

A Comparison of the Effect of Intermittent and Continuous Infusion of Meropenem on the Prevalence of Nausea in Pediatric Cystic Fibrosis Patients

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Dayton Children's Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the incidence of nausea and vomiting following short intermittent versus prolonged intermittent infusion of meropenem.

Detailed description

1. To assess the number of episodes of emesis following both short and prolonged intermittent infusion of meropenem. 2. To assess the number of episodes of emesis corresponding to the peak serum concentration of meropenem. 3. To assess the number of episodes of emesis corresponding to the area under the meropenem serum concentration time curve. 4. To assess reported nausea, measured through administered dosages of anti-nausea medication, following both short and prolonged intermittent infusion of meropenem. 5. To assess reported nausea, measured through administered doses of anti-nausea medication, corresponding to peak concentrations of meropenem. 6. To assess reported nausea, measured through administered dosages of anti-nausea medication, corresponding to the area under the serum concentration time curve 7. To assess reported nausea, measured through patient-reported nausea measured using pictorial scales of severity of nausea in pediatric patients, following both short and prolonged intermittent infusion of meropenem. 8. To assess reported nausea, measured through patient-reported nausea measured using pictorial scales of severity corresponding to the peak serum concentrations of meropenem. 9. To assess reported nausea, measured through patient-reported nausea measured using pictorial scales of severity corresponding to the area under the meropenem serum concentration time curve.

Conditions

• Cystic Fibrosis

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2014-01-29
• Last updated: 2016-02-08

Locations

1 site across 1 country: United States