MedPath

Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)

Phase 2
Completed
Conditions
Community Acquired Pneumonia
Infections
Interventions
Drug: amoxicillin clavulanate
Registration Number
NCT01530763
Lead Sponsor
Forest Laboratories
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)

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
161
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Ceftriaxoneamoxicillin clavulanate-
CeftriaxoneCeftriaxone-
Ceftaroline fosamilamoxicillin clavulanate-
Ceftaroline fosamilCeftaroline fosamil-
Primary Outcome Measures
NameTimeMethod
Evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects age 2 months to <18 years with CABP requiring hospitalizationBetween 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 Outcome Measures
NameTimeMethod
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).

Trial Locations

Locations (3)

Investigational Site

🇺🇦

Zaporizhia, Ukraine

Investigational Site2

🇬🇪

Tbilisi, Georgia

Investigational Site3

🇬🇪

Tbilisi, Georgia

Investigational Site
🇺🇦Zaporizhia, Ukraine

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.