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

NCT01530763 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2015-01-13

No results posted yet for this study

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.

Conditions

Interventions

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)

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.)

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-04-30
Completion
2014-07-31

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01530763 on ClinicalTrials.gov