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

Forest Laboratories40 enrolled

Overview

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

To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in pediatric subjects ages 2 months to \< 18 years who are initially hospitalized with Complicated Community Acquired Bacterial Pneumonia (CABP) at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Infections Pneumonia

Interventions

Ceftaroline fosamilDRUG

* Subjects ≥ 6 months: IV ceftaroline fosamil 15 mg/kg (or 600 mg if \> 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour) * Subjects \< 6 months: IV ceftaroline fosamil 10 mg/kg infused over 120 (± 10) minutes q8h (± 1 hour) Optional Oral Switch: * PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h * PO clindamycin 13 mg/kg/dose * PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h

IV Ceftriaxone and VancomycinDRUG

* IV ceftriaxone 75 mg/kg/day (up to 4 g/day) divided equally every 12 hours (q12h) (± 2 hours) infused over 30 (± 10) minutes AND * IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) infused over at least 60 minutes. Optional Oral Switch: * PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h * PO clindamycin 13 mg/kg/dose * PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Presence of CABP warranting 3 days of initial hospitalization * Confirmed presence of indicators of complicated CABP Exclusion Criteria: * Hypersensitivity or allergic reaction to vancomycin or any β-lactam antimicrobial * Confirmed or suspected infection with a pathogen known to be resistant to IV study drugs or known infection at baseline with a sole atypical organism * Confirmed or suspected respiratory tract infection attributable to sources other than community acquired bacterial pneumonia * Non-infectious causes of pulmonary infiltrates

Locations (21)

Investigational Site

Long Beach, California, United States

Unnamed facility

Oakland, California, United States

Outcomes

Primary Outcomes

Evaluate the safety and tolerability of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects ages 2 months to < 18 years with complicated community-acquired bacterial pneumonia (CABP)

Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with complicated CABP. Summaries of patient AEs, SAEs, deaths, discontinuations due to AEs, laboratory evaluations (hematology studies, comprehensive and metabolic panel), and vital signs will be provided for each treatment group.

Time frame: between 1 and 57 days

Secondary Outcomes

To evaluate the efficacy of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA).

Evaluate the efficacy of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA) by assessing clinical stability of the subject at study day 4 and clinical outcome at End of IV, End of Treatment and Test of Cure.

Time frame: between 4 and 57 days

Evaluate the pharmacokinetics of ceftaroline in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)

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)

Time frame: between 4 and 57 days

Data from ClinicalTrials.gov

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