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

Phase 4

Completed

• Conditions: Infections
• Interventions: Drug: Ceftriaxone plus vancomycin; Drug: Ceftaroline fosamil

• Registration Number: NCT01645735
• Lead Sponsor: Forest Laboratories

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2012-07-18
• Study First Posted: 2012-07-20
• Study Start: 2012-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2014-09-29
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-24
• Last Update Submitted: 2015-12-24
• Results First Posted: 2016-02-01
• Last Update Posted: 2016-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ceftriaxone plus vancomycin	Ceftriaxone plus vancomycin	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
Ceftaroline	Ceftaroline fosamil	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

Primary Outcome Measures

Name	Time	Method
Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population	Study Day 4	Clinical response was defined as meeting all of the following criteria: * Symptom Improvement - Improvement in at least 2 and no worsening of any of the following symptoms compared to baseline: * Cough; * Dyspnea; * Sputum production; * Chest pain; * Clinical Stability (per Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) guidelines; Mandell et al, 2007): * Temperature ≤ 37.8°C; * Heart rate ≤ 100 beats/min; * Respiratory rate ≤ 24 breaths/min; * Systolic blood pressure ≥ 90 mmHg; * Oxygen saturation ≥ 90%; * Confusion/disorientation absent
Clinical Outcome at Test of Cure (TOC) in the MITT Population	Test of Cure, an average of 3 weeks	An assessment of clinical outcome was made by the Investigator at TOC. The clinical outcome categories were: Cure: Resolution of all acute signs and symptoms of CABP or improvement to such an extent that no further antimicrobial therapy was required; Failure: Subjects who meet either of the following criteria: * Incomplete resolution or worsening of CABP signs and symptoms or development of new CABP signs or symptoms requiring alternative nonstudy antimicrobial therapy; * Death in which CABP is contributory; Indeterminate: Study data are not available for evaluation of efficacy for any reason, including: * Death in which CABP is clearly noncontributory; * Lost to follow-up; * Extenuating circumstances precluding classification as a cure or failure; A favorable clinical outcome at Test-of Cure (TOC) was clinical cure.

Trial Locations

Locations (1)

Investigational Site; 🇺🇦 Zaporizhzhya, Ukraine