Infections, Community Acquired Pneumonia
Conditions
Keywords
Infections, Pediatrics, Teflaro, cephalosporin
Brief summary
This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.
Detailed description
To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in children who are initially hospitalized with Community Acquired Bacterial Pneumonia (CABP)
Interventions
Treatment Group 1: Drug: Ceftaroline fosamil Children ≥ 6 months: IV ceftaroline fosamil 12 mg/kg for subjects weighing ≤ 33 kg or 400 mg for subjects weighing \> 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) Children \< 6 months: Ceftaroline fosamil 8 mg/kg over 60 (± 10) minutes q8h (± 1 hour)
DRUGCeftriaxone
Treatment group 2: 75 mg/kg/day up to 4 g/day IV in equally divided doses, each infused over 30 (± 10) minutes q12hr (± 2 hours)
Oral Switch for Treatment Groups 1 and 2: PO amoxicillin clavulanate 90 mg/kg/day divided q12h in subjects with infections due to susceptible organisms on or after Study Day 4 (a minimum of 7 IV doses required if randomized to ceftaroline.)
Sponsors
AstraZeneca
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects age 2 months to <18 years with CABP requiring hospitalization | Between 1 and 50 days. | Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with CABP. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology studies, comprehensive and metabolic panel), vital signs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to under 18 years with CABP. | Between 4 and 50 days | * Clinical response by subject and by baseline pathogen at Study Day 4 in the Modified Intent-to-Treat (MITT) and Microbiological modified Intent-to Treat (mMITT) Populations * Clinical stability by subject and by baseline pathogen at Study Day 4 in the MITT and mMITT Populations * Clinical outcome at EOIV, EOT, and TOC in the MITT and Clinically Evaluable (CE) Populations * Clinical and microbiological outcomes by subject and by pathogen at TOC in the mMITT and Microbiologically Evaluable (ME) Populations * Clinical relapse at LFU in the MITT Population * Emergent infections in the mMITT Population |
| To evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to under 18 years. | Between 4 and 50 days | Analyze concentrations of ceftaroline, ceftaroline fosamil (prodrug), and ceftaroline M-1 (inactive metabolite) in plasma, and, if available, in cerebrospinal fluid (CSF; if collected as part of standard of care). |
Countries
Argentina, Bulgaria, Georgia, Greece, Hungary, Poland, Spain, Ukraine, United States
Outcome results
None listed