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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ceftaroline

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

Group Type EXPERIMENTAL

Ceftaroline fosamil

Intervention Type DRUG

Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days

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

Group Type ACTIVE_COMPARATOR

Ceftriaxone plus vancomycin

Intervention Type DRUG

Ceftriaxone 2g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days

Interventions

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Ceftaroline fosamil

Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days

Intervention Type DRUG

Ceftriaxone plus vancomycin

Ceftriaxone 2g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days

Intervention Type DRUG

Other Intervention Names

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Teflaro PPI-0903 TAK-599 TAK599 PPI0903 Teflaro

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No