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

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Infections

Treatments: Drug: Ceftaroline fosamil; Drug: Ceftriaxone plus vancomycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01645735

P903-25

Details and patient eligibility

About

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).

Full description

A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and safety of Ceftaroline fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects with Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus aureus.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects are required to meet All of the following inclusion criteria:

  1. Male or female, ≥ 18 years old
  2. Presence of CABP requiring hospitalization
  3. 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:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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49 participants in 2 patient groups

Ceftaroline

Experimental group

Description:

Ceftaroline fosamil 600 mg Intravenous (IV) administration over 60 minutes, every 8 hours (q8h); dosing to be adjusted for renal function; treatment duration 5 to 14 days

Treatment:

Drug: Ceftaroline fosamil

Ceftriaxone plus vancomycin

Active Comparator group

Description:

Ceftriaxone 2 g IV over 30 minutes once per day (q24h) plus vancomycin 15 mg/kg IV every 12 hours (q12h) initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days

Treatment:

Drug: Ceftriaxone plus vancomycin