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NCT01400867 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections
A Phase 2 study of Infections, Pediatrics, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 163
- Enrollment target
- 20
- Study locations
NCT01400867: Completed Phase 2 study of Infections, Pediatrics, sponsored by Forest Laboratories.
NCT01400867 is a Phase 2 study of Infections, Pediatrics that has completed, run by Forest Laboratories. The registered enrollment target is 163 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01400867, a Phase 2 study of Infections, Pediatrics, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 163 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.
Primary Outcome
Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with skin infections. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology studies, comprehensive and metabolic panel), pain scales, vital signs, and physical examinations will be provided for each treatment group.
Conditions Studied
Interventions
- DRUG Ceftaroline fosamil
- DRUG Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam
- DRUG Cephalexin or Clindamycin or Linezolid
Study Locations (20)
New York
- Investigational Site - Brooklyn - Brooklyn
- Investigational Site - New Hyde Park - New Hyde Park
- Investigational Site - Rochester - Rochester
- Investigational Site - Bronx - The Bronx
Ohio
- Investigational Site - Akron - Akron
- Investigational Site - Cleveland 1 - Cleveland
- Investigational Site - Cleveland 2 - Cleveland
- Investigational Site - Toledo - Toledo
Illinois
- Investigational Site - Chicago 1 - Chicago
- Investigational Site - Chicago 2 - Chicago
- Investigational Site - Springfield - Springfield
California
- Investigational Site - Orange - Orange
- Investigational Site - San Diego - San Diego
Arizona
- Investigational Site - Phoenix - Phoenix
Florida
- Investigational Site - Jacksonville - Jacksonville
Georgia
- Investigational Site - Atlanta - Atlanta
Louisiana
- Investigational Site - Shreveport - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT01400867 record still lists
NCT01400867 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher).
The record links to 1 condition, with Infections, Pediatrics appearing as the primary indexed condition, and to 3 interventions - of which Ceftaroline fosamil is the first listed.
NCT01400867 names 20 study sites across 11 states, led by New York, Ohio, Illinois.
Frequently Asked Questions
What is clinical trial NCT01400867 about?
NCT01400867 is a clinical study titled "Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections". This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.
What is the current status of trial NCT01400867?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 163 participants. The study started on 2011-12. Estimated completion is 2014-07.
What conditions does trial NCT01400867 study?
This clinical trial studies the following conditions: Infections, Pediatrics.
What interventions are being tested in trial NCT01400867?
The interventions under investigation include: Ceftaroline fosamil (DRUG), Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam (DRUG), Cephalexin or Clindamycin or Linezolid (DRUG).
Who is sponsoring clinical trial NCT01400867?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01400867 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01400867's enrollment target sits among peer trials
163 418th of 2000 higher than 1,583 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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