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COMPLETED Phase 2

Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections

NCT01400867 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 163 participants
Start Date 2011-12
Est. Completion 2014-07
Phase Phase 2

Sponsor

Forest Laboratories

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01400867

The ClinicalTrials.gov registry entry for NCT01400867 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 163 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01400867 reports 20 study locations spanning 11 distinct geographic areas — top geographies include New York, Ohio, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01400867?

This trial is sponsored by Forest Laboratories, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial