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NCT03771313 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic Fibrosis
A Phase 4 study of Cystic Fibrosis, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT03771313: Completed Phase 4 study of Cystic Fibrosis, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03771313 is a Phase 4 study of Cystic Fibrosis that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 8 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03771313, a Phase 4 study of Cystic Fibrosis, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, single center, prospective study of patients with a diagnosis of cystic fibrosis (CF) and a history of methicillin-resistant Staphylococcus aureus (MRSA), also known as oxacillin-resistant Staphylococcus aureus (ORSA), being treated with intravenous ceftaroline. Patients will have intravenous ceftaroline dosed according to current recommendations based upon its approved usage in pediatric patients for community acquired pneumonia. The investigators will analyze pharmacokinetic (PK) and pharmacodynamic (PD) data using serum concentrations of ceftaroline measured at various time-points following infusion of ceftaroline to develop PK/PD guided dosing strategies of ceftaroline in pediatric CF patients that would be tailored to account for bacterial susceptibility and disease progression.
Primary Outcome
Interpret PK/PD target attainment based on percent time of the free ceftaroline concentration (=PK) above minimum inhibitory concentration (=PD index)
Conditions Studied
Interventions
- DRUG Ceftaroline
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2017-09-01 |
| Est. Completion | 2025-07-31 |
| Phase | Phase 4 |
What the finished NCT03771313 record still lists
NCT03771313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which Ceftaroline is the first listed.
NCT03771313 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03771313 about?
NCT03771313 is a clinical study titled "Pharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic Fibrosis". This is an open-label, single center, prospective study of patients with a diagnosis of cystic fibrosis (CF) and a history of methicillin-resistant Staphylococcus aureus (MRSA), also known as oxacillin-resistant Staphylococcus aureus (ORSA), being treated with intravenous ceftaroline. Patients will ...
What is the current status of trial NCT03771313?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2017-09-01. Estimated completion is 2025-07-31.
What conditions does trial NCT03771313 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT03771313?
The interventions under investigation include: Ceftaroline (DRUG).
Who is sponsoring clinical trial NCT03771313?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03771313 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03771313's enrollment target sits among peer trials
8 165th of 169 higher than 3 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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