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NCT00423657 · ClinicalTrials.gov registry record · Phase 3

Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

A Phase 3 study of Bacterial Infections, sponsored by Forest Laboratories.

Completed
Registry status
Phase 3
Development phase
680
Enrollment target
20
Study locations

NCT00423657: Completed Phase 3 study of Bacterial Infections, sponsored by Forest Laboratories.

NCT00423657 is a Phase 3 study of Bacterial Infections that has completed, run by Forest Laboratories. The registered enrollment target is 680 participants, above the 101-participant average among 17 other Bacterial Infections trials with a reported enrollment target (573% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00423657, a Phase 3 study of Bacterial Infections, has completed, sponsored by Forest Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
680 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

Primary Outcome

Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary. Failure: Requirement of alternative antimicrobial therapy for primary infection of complicated skin and skin structure infection (cSSSI) due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis afte

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG ceftaroline
  • DRUG vancomycin plus aztreonam

Study Locations (20)

California

  • Investigational Site - Buena Park
  • Investigational Site - Hawaiian Gardens
  • Investigational Site - Los Angeles
  • Investigational Site - Pasadena
  • Investigational Site - San Diego
  • Investigational Site - San Jose

Other

  • Investigational Site - Buenos Aires
  • Investigational Site - Córdoba
  • Investigational Site - Santa Fe

Georgia

  • Investigational Site - Columbus
  • Investigational Site - Marietta

Florida

  • Investigational Site - Atlantis

Illinois

  • Investigational Site - Springfield

Maryland

  • Investigational Site - Baltimore

Minnesota

  • Investigational Site - Minneapolis

Montana

  • Investigational Site - Butte

Trial Details

FieldValue
Enrollment Target 680 participants
Start Date 2007-03
Est. Completion 2007-12
Phase Phase 3
Forest Laboratories

145 total trials

What the finished NCT00423657 record still lists

NCT00423657 is an interventional study that assigns participants to a tested intervention. The registered 680 participants enrollment target is mid-sized for trials with a published cap, above the 101-participant average among 17 other Bacterial Infections trials with a reported enrollment target (573% higher).

The record links to 1 condition, with Bacterial Infections appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00423657 names 20 study sites across 12 states, led by California, Other, Georgia.

Frequently Asked Questions

What is clinical trial NCT00423657 about?

NCT00423657 is a clinical study titled "Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections". The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

What is the current status of trial NCT00423657?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 680 participants. The study started on 2007-03. Estimated completion is 2007-12.

What conditions does trial NCT00423657 study?

This clinical trial studies the following conditions: Bacterial Infections.

What interventions are being tested in trial NCT00423657?

The interventions under investigation include: Placebo (DRUG), ceftaroline (DRUG), vancomycin plus aztreonam (DRUG).

Who is sponsoring clinical trial NCT00423657?

This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00423657 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Bacterial Infections

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 NCT00423657's enrollment target sits among peer trials

680 1st of 17 higher than 17 of 17 other Bacterial Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Bacterial Infections 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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Source: ClinicalTrials.gov NCT00423657, the US trial registry maintained by the National Library of Medicine. NCT00423657 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.