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

Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530763
• Other study ID #: P903-31
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 8, 2012
• Last updated: January 12, 2015
• Start date: September 2012
• Est. completion date: July 2014

Study information

• Verified date: January 2015
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Ethics CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: Ethics CommitteeUkraine: Ethics CommitteeUkraine: Ministry of HealthGreece: Ethics CommitteeGreece: Hellenic Republic Ministry of Health National Organization for MedicinesHungary: National Institute for Quality and Organizational Development in Healthcare and MedicinesHungary: Ethics CommitteeSpain: Comité Ético de Investigación ClínicaSpain: Ethics CommitteeArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaArgentuna: Ethics CommitteeBrazil: ANVISA (Agência Nacional de Vigilância Sanitária)Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in children who are initially hospitalized with Community Acquired Bacterial Pneumonia (CABP)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 18 Years

Eligibility

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 ß-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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Infections
• Pneumonia
• Pneumonia, Bacterial

Intervention

Drug:
• Ceftaroline fosamil
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)
• Ceftriaxone
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)
• amoxicillin clavulanate
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.)

Locations

Country	Name	City	State
Argentina	Investigational Site	Capital Federal	Buenos Aires
Argentina	Investigational Site	Cordoba
Bulgaria	Investigational Site	Plovdiv
Bulgaria	Investigational Site	Ruse
Bulgaria	Investigational Site	Sofia
Bulgaria	Investigational Site2	Sofia
Georgia	Investigational Site	Tbilisi
Georgia	Investigational Site2	Tbilisi
Georgia	Investigational Site3	Tbilisi
Greece	Investigational Site	Athens	Attica
Greece	Investigational Site	Heraklion	Crete
Greece	Investigational Site	Larissa	Thessaly
Greece	Investigational Site	Thessaloniki	Macedonia
Hungary	Investigational Site	Ajka
Hungary	Investigational Site	Budapest
Hungary	Investigational Site	Gyula	Bekes
Hungary	Investigational Site	Nagykanisza
Hungary	Investigational Site	Nyiregyhaza
Hungary	Investigational Site	Szeged
Hungary	Investigational Site	Veszprem
Hungary	Investigational Site	Zalaegerszeg
Poland	Investigational Site	Lublin
Poland	Investigational Site	Rzeszow
Poland	Investigational Site	Warsaw
Spain	Investigational Site	Cordoba
Spain	Investigational Site	Madrid
Ukraine	Investigational Site	Donetsk
Ukraine	Investigational Site	Ivano-Frankivsk
Ukraine	Investigational Site	Kryvyi Rih
Ukraine	Investigational Site	Kyiv
Ukraine	Investigational Site	Zaporizhia
United States	Investigational Site	Boston	Massachusetts
United States	Investigational Site	Cleveland	Ohio
United States	Investigational Site	Houston	Texas
United States	Investigational Site	Long Beach	California
United States	Investigational Site	Memphis	Tennessee
United States	Investigational Site	Morgantown	West Virginia
United States	Investigational Site	Oakland	California
United States	Investigational Site	Orange	California
United States	Investigational Site	Pittsuburg	Pennsylvania
United States	Investigational Site	Salt Lake City	Utah
United States	Investigational Site	San Diego	California
United States	Investigational Site	Syracuse	New York
United States	Investigational Site	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Georgia,  Greece,  Hungary,  Poland,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects age 2 months to <18 years with CABP requiring hospitalization	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.	Between 1 and 50 days.	Yes
Secondary	Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to under 18 years with CABP.	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	Between 4 and 50 days	No
Secondary	To evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to under 18 years.	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).	Between 4 and 50 days	No

External Links

•   sponsor website