A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline versus Ceftriaxone, with the Option of a Switch to Oral Amoxicillin-clavulanate, in the Treatment of Adult Subjects with Community-Acquired Pneumonia
- Conditions
- Adult Subjects with Community-Acquired PneumoniaMedDRA version: 9.1Level: LLTClassification code 10010120Term: Community acquired pneumonia
- Registration Number
- EUCTR2007-000598-41-AT
- Lead Sponsor
- Cerexa, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 550
Subjects are required to meet the following inclusion criteria:
1. Males and females 18 or more years of age
2. Community-acquired pneumonia meeting the following criteria:
I. Radiographically-confirmed pneumonia (new or progressive pulmonary infiltrate(s) on chest radiograph (CXR) or chest computed tomography (CT) scan consistent with bacterial pneumonia)
AND
II. Acute illness (=7 days’ duration) with at least three of the following clinical signs or symptoms consistent with a lower respiratory tract infection:
• New or increased cough
• Purulent sputum or change in sputum character
• Auscultatory findings consistent with pneumonia (e.g. rales, egophony, findings of consolidation)
• Dyspnea, tachypnea, or hypoxemia (O2 saturation <90% on room air or pO2 <60 mm Hg)
• Fever greater than 38ºC oral (>38.5ºC rectally or tympanically) or hypothermia (<35ºC)
• White blood cell (WBC) count greater than 10,000 cells/mm3 or less than 4,500 cells/mm3
• Greater than 15% immature neutrophils (bands) irrespective of WBC count
AND
III. PORT score greater than 50 and less than or equal to 130 (i.e. PORT Risk Class II, III, or IV) (see Section 9.1)
3. The subject must require initial hospitalization, or treatment in an emergency room or urgent care setting, by the standard of care.
4. The subject’s infection would require initial treatment with IV antimicrobials.
5. Female subjects of child-bearing potential, and those who are fewer than 2 years post-menopausal, must agree to, and comply with, using highly effective methods of birth control (i.e. condom plus spermicide, combined oral contraceptive, implant, injectable, indwelling intrauterine device, sexual abstinence, or a vasectomized partner) while participating in this study.
6. Written informed consent, willingness, and ability to comply with all study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects must NOT meet any of the following exclusion criteria:
1. PORT score less than or equal to 50 (PORT Risk Class I), PORT score greater than 130 (PORT Risk Class V), or requiring admission to an intensive care unit
2. CAP suitable for outpatient therapy with an oral antimicrobial agent
3. Confirmed or suspected Respiratory respiratory tract infections attributable to sources other than community-acquired bacterial pathogens (e.g. ventilator-associated pneumonia, hospital-acquired pneumonia, visible/gross aspiration pneumonia, suspected active viral infection, fungal infection, active tuberculosis or mycobacterial infection of the lung).
4. Non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
5. Pleural empyema (not including sterile parapneumonic effusions)
6. Microbiologically-documented infection with a pathogen known to be resistant to ceftriaxone, or epidemiological or clinical context suggesting high likelihood of a ceftriaxone-resistant typical” bacterial pathogen (e.g. Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus) [MRSA]).
8. Previous treatment with an antimicrobial for treatment of CAP within 96 hours leading up to randomization
EXCEPTIONS: Subjects may be eligible despite prior antimicrobial therapy if they meet the following conditions:
EITHER:
• A single dose of an oral or intravenous short-acting antibiotic for CAP (see Appendix 2 for a list of allowed and disallowed antibiotics)
OR BOTH OF THE FOLLOWING:
• Unequivocal clinical evidence of treatment failure (e.g. worsening signs and symptoms) following at least 48 hours of prior systemic antimicrobial therapy
• Isolation of an organism resistant to the prior, systemic, antimicrobial therapy
9. Failure of ceftriaxone (or other third-generation cephalosporin) as therapy for this episode of CAP, or prior isolation of an organism resistant in vitro to ceftriaxone
10. History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial
11. History of any hypersensitivity or allergic reaction to clariazithromycin or any macrolide/ ketolide
12. Inability to take oral azithromycin, if IV azithromycin is not availableclarithromycin
13. Requirement for concomitant therapy with any drug known to exhibit a contraindicated drug-drug interaction with clarithromycin; or labeled contraindication to use of clarithromycin
14. Past or current history of epilepsy or seizure disorder
EXCEPTIONS: well-documented febrile seizure of childhood
15. Requirement for concomitant antimicrobial or systemic antifungal therapy for any reason
EXCEPTIONS: topical antifungal or antimicrobial therapy, single oral dose of any antifungal for treatment of vaginal candidiasis
16. Neoplastic lung disease, cystic fibrosis, progressively fatal disease, chronic neurological disorder preventing clearance of pulmonary secretions, or life expectancy of less than or equal to 3 months
17. Probenecid administration within 3 days prior to initiation of the study treatment regimen or requirement for concomitant therapy with probenecid
18. Infections or conditions requiring concomitant systemic corticosteroids
EXCEPTIONS: the corticosteroid dose equivalent is less than 40 mg prednisone per day
19. Severely impaired renal function (CrCl = 30 mL/min) estimated by the Cockroft-Gault formula
20. Evidence of significant hepatic, hematological, or immunologic d
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method