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

NCT01669980 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-11-02

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Ceftaroline fosamil

* 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

DRUG

IV Ceftriaxone and Vancomycin

* 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

Sponsors & Collaborators

  • 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
2012-10-31
Primary Completion
2014-05-31
Completion
2014-08-31

Countries

  • United States
  • Argentina
  • Georgia
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

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 NCT01669980 on ClinicalTrials.gov