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Sponsored by: |
Cerexa, Inc. |
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Information provided by: | Cerexa, Inc. |
ClinicalTrials.gov Identifier: | NCT00621504 |
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia
Condition | Intervention | Phase |
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Bacterial Pneumonia |
Drug: ceftaroline Drug: ceftriaxone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone, With Adjunctive Clarithromycin, in the Treatment of Adult Subjects With Community-Acquired Pneumonia |
Estimated Enrollment: | 610 |
Study Start Date: | December 2007 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: ceftaroline
2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours, for 5 to 7 days
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B: Active Comparator |
Drug: ceftriaxone
1 g dose parenteral infused over 30 minutes, every 24 hours, for 5 to 7 days
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The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia. Clinical trials for this study is held in many countries
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects are required to meet the following inclusion criteria:
Exclusion Criteria:
Subjects must NOT meet any of the following exclusion criteria:
Study Director: | Thomas M File, MD, MS | Summa Health System |
Responsible Party: | Cerexa ( Senior Vice President, Clinical Development ) |
Study ID Numbers: | P903-08 |
Study First Received: | February 11, 2008 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00621504 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; Hong Kong: Department of Health; Hong Kong: Ethics Committee; Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee; Malaysia: Ministry of Health; Thailand: Ethical Committee; Thailand: Food and Drug Administration; Thailand: Khon Kaen University Ethics Committee for Human Research; Thailand: Ministry of Public Health; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Argentina: Human Research Bioethics Committee; Brazil: Ministry of Health; Brazil: National Committee of Ethics in Research; Brazil: National Health Surveillance Agency; Russia: Ethics Committee; Russia: Ministry of Health and Social Development of the Russian Federation; Russia: Pharmacological Committee, Ministry of Health; Ukraine: Ministry of Health; Ukraine: State Pharmacological Center - Ministry of Health; Lithuania: Bioethics Committee; Lithuania: State Medicine Control Agency - Ministry of Health; Bulgaria: Bulgarian Drug Agency; Bulgaria: Ministry of Health; Romania: Ministry of Public Health; Romania: National Medicines Agency |
ceftaroline Community-acquired pneumonia CAP Streptococcus pneumoniae Haemophilus influenzae Mycoplasma pneumoniae Chlamydophila spp Legionella spp |
Multi-drug resistant Streptococcus pneumoniae (MDRSP) antimicrobial resistance pneumococci Ceftriaxone bacteria ß-lactam beta-lactam antibiotic |
Bacterial Infections Lactams Pneumonia, Mycoplasma Mycoplasmal pneumonia Haemophilus influenzae Mycoplasma Infections Ceftriaxone Pleuropneumonia |
Clarithromycin Respiratory Tract Diseases Respiratory Tract Infections Pneumonia, Bacterial Lung Diseases Beta-Lactams Influenza, Human Pneumonia |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |