Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)
| Status: | Completed |
|---|---|
| Conditions: | Pneumonia |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 5/3/2014 |
| Start Date: | September 2012 |
| End Date: | October 2014 |
| Contact: | Cerexa Trial Coordinator |
| Email: | clinicaltrials@cerexa.com |
| Phone: | 510-285-9200 |
A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone in Pediatric Subjects With Community-acquired Bacterial Pneumonia Requiring Hospitalization
This is a study of safety and effectiveness of ceftaroline fosamil in children with
Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.
Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.
To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in
children who are initially hospitalized with Community Acquired Bacterial Pneumonia (CABP)
children who are initially hospitalized with Community Acquired Bacterial Pneumonia (CABP)
Inclusion Criteria:
- Male or female, 2 months to < 18 years old.
- Presence of CABP requiring hospitalization and IV antibacterial therapy
Exclusion Criteria:
- Documented history of any hypersensitivity of allergic reaction to any β-lactam
antimicrobial.
- Confirmed or suspected infection with a pathogen known to be resistant to
ceftriaxone.
- Confirmed or suspected respiratory tract infection attributed to sources other than
CABP pathogens.
- Non-infectious causes of pulmonary infiltrates.
We found this trial at
14
sites
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