Phase 4
N=49
Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus
Infections
Bottom Line
View on ClinicalTrials.gov: NCT01645735 ↗Enrolled (actual)
49
Serious AEs
10.2%
Results posted
Feb 2016
Primary outcome: Primary: Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population — 14; 8; 16; 8 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ceftaroline fosamil (Drug); Ceftriaxone plus vancomycin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population |
14; 8; 16; 8; 2; 1 | — |
| PRIMARY Clinical Outcome at Test of Cure (TOC) in the MITT Population |
27; 15; 3; 2; 2; 0 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Subjects are required to meet All of the following inclusion criteria:
- Male or female, ≥ 18 years old
- Presence of CABP requiring hospitalization
- Presence of CABP meeting the following criteria:
I. confirmed pneumonia (new or progressive pulmonary) II. Acute illness (≤ 7 days' duration) with at least 3 clinical signs or symptoms consistent with a lower respiratory tract infection
MRSA Risk Factors
- MRSA-positive blood culture or respiratory specimen or a risk factor for MRSA such as a history of colonization with MRSA
Exclusion Criteria
- Subjects must Not meet any of the following exclusion criteria at baseline:
- 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
Data sourced from ClinicalTrials.gov (NCT01645735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.