Clinical trial NCT01645735: Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infections
Keywords: Infections
Teflaro
cephalosporin
Ceftaroline
antibiotics
pneumonia
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2012-07-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population
timeFrame: Study Day 4
measure: Clinical Outcome at Test of Cure (TOC) in the MITT Population
timeFrame: Test of Cure, an average of 3 weeks
Secondary outcomes:
Other outcomes:
measure: Microbiological Outcomes by Baseline Pathogen at TOC in the Microbiological Modified Intent-to-Treat (mMITT) Population
timeFrame: Test of Cure, an average of 3 weeks
measure: Safety Evaluation
timeFrame: Baseline (Day 0) to Day 49
Locations:
city: Phoenix
country: United States
facility: Investigational Site
state: Arizona
city: Sylmar
country: United States
facility: Investigational Site
state: California
city: DeLand
country: United States
facility: Investigational Site
state: Florida
city: Chicago
country: United States
facility: Investigational Site
state: Illinois
city: Kansas City
country: United States
facility: Investigational Site
state: Kansas
city: Royal Oak
country: United States
facility: Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Investigational Site
state: Minnesota
city: St. Louis
country: United States
facility: Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Investigational Site
state: Nebraska
city: Laconia
country: United States
facility: Investigational Site
state: New Hampshire
city: Columbus
country: United States
facility: Investigational Site
state: Ohio
city: Lima
country: United States
facility: Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Investigational Site
state: Oklahoma
city: Tbilisi
country: Georgia
facility: Investigational Site
city: Matrahaza
country: Hungary
facility: Investigational Site
city: Lodz
country: Poland
facility: Investigational Site
city: Lublin
country: Poland
facility: Investigational Site
city: Wilkowice-Bystra
country: Poland
facility: Investigational Site
city: Craiova
country: Romania
facility: Investigational Site
state: Dolj
city: Bucharest
country: Romania
facility: Investigational Site
city: Iasi
country: Romania
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Investigational Site
city: Alicante
country: Spain
facility: Investigational Site
city: Barcelona
country: Spain
facility: Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Investigational Site
city: Ivano-Frankivsik
country: Ukraine
facility: Investigational Site
city: Kharkiv
country: Ukraine
facility: Investigational Site
city: Kyiv
country: Ukraine
facility: Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: Investigational Site
Study officials:
affiliation: Forest Laboratories Inc, an affiliate of Allergan plc
name: Medical Monitor
role: STUDY_DIRECTOR
References: