CompletedPhase 4

Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus

United States49 participantsStarted 2012-10

Plain-language summary

The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female, ≥ 18 years old
✓. Presence of CABP requiring hospitalization
✓. Presence of CABP meeting the following criteria:

Exclusion criteria

✕. History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
✕. Suspected or microbiologically-documented infection with a pathogen known to be resistant to any of the study drugs
✕. Non-infectious causes of pulmonary infiltrates (eg, pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
✕. More than 24 hours of potentially effective systemic antibacterial therapy for CABP within 96 hours before randomization
✕. End-stage renal disease \[Creatinine Clearance (CrCl) \< 15\], including hemodialysis
✕. Evidence of significant hepatic, hematological, or immunocompromising condition

What they're measuring

Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population

Timeframe: Study Day 4

Clinical Outcome at Test of Cure (TOC) in the MITT Population

Timeframe: Test of Cure, an average of 3 weeks

Trial details

NCT IDNCT01645735

SponsorForest Laboratories

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-12

Results submitted2014-09-29

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