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

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infections

Intervention: Ceftaroline fosamil (Drug); Ceftriaxone plus vancomycin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Forest Laboratories

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Evaluate the efficacy of ceftaroline and azithromycin versus ceftriaxone and azithromycin plus vancomycin in adult subjects with community-acquired bacterial pneumonia (CABP) at risk for infection due to methicillin-resistant Staphylococcus aureus (MRSA)

Evaluate the safety of ceftaroline and azithromycin versus ceftriaxone and azithromycin plus vancomycin in adult subjects with CABP at risk for infection due to MRSA

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 (CrCl < 15), including hemodialysis 6. Evidence of significant hepatic, hematological, or immunocompromising condition

Locations and Contacts

Investigational Site, Tbilisi 0144, Georgia

Investigational Site, Matrahaza 3233, Hungary

Investigational Site, Lodz 90-153, Poland

Investigational Site, Lublin 20-954, Poland

Investigational Site, Wilkowice-Bystra 43-365, Poland

Investigational Site, Bucharest 030303, Romania

Investigational Site, Iasi 700115, Romania

Investigational Site, Moscow 109240, Russian Federation

Investigational Site, St. Petersburg 196247, Russian Federation

Investigational Site, Yaroslavl 150003, Russian Federation

Investigational Site, Alicante 03010, Spain

Investigational Site, Barcelona 08304, Spain

Investigational Site, Dnipropetrovsk 49059, Ukraine

Investigational Site, Ivano-Frankivsik 76018, Ukraine

Investigational Site, Kharkiv 61115, Ukraine

Investigational Site, Kyiv 03680, Ukraine

Investigational Site, Zaporizhzhya 69035, Ukraine

Investigational Site, Phoenix, Arizona 85008, United States

Investigational Site, Sylmar, California 91342, United States

Investigational Site, Craiova, Dolj 200515, Romania

Investigational Site, DeLand, Florida 32720, United States

Investigational Site, Chicago, Illinois 60611, United States

Investigational Site, Kansas City, Kansas 66012, United States

Investigational Site, Royal Oak, Michigan 48073, United States

Investigational Site, Minneapolis, Minnesota 55145, United States

Investigational Site, St. Louis, Missouri 63110, United States

Investigational Site, Omaha, Nebraska 68131, United States

Investigational Site, Laconia, New Hampshire 03246, United States

Investigational Site, Columbus, Ohio 43215, United States

Investigational Site, Lima, Ohio 45801, United States

Investigational Site, Oklahoma City, Oklahoma 73104, United States

Additional Information

Starting date: October 2012
Last updated: April 15, 2014

Page last updated: August 23, 2015

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