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

Purpose

This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.

Condition	Intervention	Phase
Infections Community Acquired Pneumonia	Drug: Ceftaroline fosamil Drug: Ceftriaxone Drug: amoxicillin clavulanate	Phase 2 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Amoxicillin Amoxicillin sodium Ceftriaxone Ceftriaxone sodium Ceftaroline Ceftaroline fosamil

U.S. FDA Resources

Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:

Evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects age 2 months to <18 years with CABP requiring hospitalization [ Time Frame: Between 1 and 50 days. ] [ Designated as safety issue: Yes ]
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:

Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to under 18 years with CABP. [ Time Frame: Between 4 and 50 days ] [ Designated as safety issue: No ]
- 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. [ Time Frame: Between 4 and 50 days ] [ Designated as safety issue: No ]
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).

Estimated Enrollment:	160
Study Start Date:	September 2012
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ceftaroline fosamil	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) Other Names: Teflaro PPI-0903 TAK-599 TAK599 PPI0903 Drug: 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.)
Active Comparator: Ceftriaxone	Drug: 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) Drug: 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.)

Arms

Assigned Interventions

Experimental: Ceftaroline fosamil

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)

Other Names:

Teflaro
PPI-0903
TAK-599
TAK599
PPI0903

Drug: 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.)

Active Comparator: Ceftriaxone

Drug: 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)

Drug: 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.)

Detailed Description:

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

Eligibility

Ages Eligible for Study:	2 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530763

Contacts

Contact: Cerexa Trial Coordinator

510-285-9200

clinicaltrials@cerexa.com

Locations

United States, California
Investigational Site	Recruiting
Orange, California, United States
Investigational Site	Recruiting
San Diego, California, United States
United States, Pennsylvania
Investigational Site	Recruiting
Pittsuburg, Pennsylvania, United States
United States, Virginia
Investigational Site	Recruiting
Norfolk, Virginia, United States
Hungary
Investigational Site	Recruiting
Ajka, Hungary

Sponsors and Collaborators

Cerexa, Inc.

AstraZeneca

More Information

Additional Information:

sponsor website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Cerexa, Inc.
ClinicalTrials.gov Identifier:	NCT01530763 History of Changes
Other Study ID Numbers:	P903-31
Study First Received:	February 8, 2012
Last Updated:	February 12, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cerexa, Inc.:

Infections
Pediatrics
Teflaro
cephalosporin

Additional relevant MeSH terms:

Pneumonia, Bacterial
Pneumonia
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Ceftriaxone
Amoxicillin-Potassium Clavulanate Combination

Clavulanic Acids
Clavulanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013