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: Ceftriaxone; Drug: Ceftaroline fosamil; 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)

Study Timeline

• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-10
• Study Start: 2012-09
• Primary Completion: 2014-04
• Study Completion: 2014-07
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-12
• Last Update Posted: 2015-01-13

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

Group	Intervention	Description
Ceftriaxone	amoxicillin clavulanate	-
Ceftriaxone	Ceftriaxone	-
Ceftaroline fosamil	amoxicillin clavulanate	-
Ceftaroline fosamil	Ceftaroline fosamil	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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