Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)
| Status: | Completed |
|---|---|
| Conditions: | Pneumonia |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 4/21/2016 |
| Start Date: | October 2012 |
| End Date: | August 2014 |
A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone Plus Vancomycin in Pediatric Subjects With Complicated Community-acquired Bacterial Pneumonia (CABP)
This is a study of safety and effectiveness of ceftaroline fosamil in children with
Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.
Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.
To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in
pediatric subjects ages 2 months to < 18 years who are initially hospitalized with
Complicated Community Acquired Bacterial Pneumonia (CABP) at high risk of infection due to
methicillin-resistant Staphylococcus aureus (MRSA)
pediatric subjects ages 2 months to < 18 years who are initially hospitalized with
Complicated Community Acquired Bacterial Pneumonia (CABP) at high risk of infection due to
methicillin-resistant Staphylococcus aureus (MRSA)
Inclusion Criteria:
- Presence of CABP warranting 3 days of initial hospitalization
- Confirmed presence of indicators of complicated CABP
Exclusion Criteria:
- Hypersensitivity or allergic reaction to vancomycin or any β-lactam antimicrobial
- Confirmed or suspected infection with a pathogen known to be resistant to IV study
drugs or known infection at baseline with a sole atypical organism
- Confirmed or suspected respiratory tract infection attributable to sources other than
community acquired bacterial pneumonia
- Non-infectious causes of pulmonary infiltrates
We found this trial at
14
sites
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