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Cephalosporin

Ceftaroline fosamil for Pneumonia

Phase 4
Waitlist Available
Research Sponsored by Forest Laboratories
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between 4 and 57 days
Awards & highlights

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.

Eligible Conditions
  • Pneumonia
  • Infections

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between 4 and 57 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and between 4 and 57 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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)
Secondary study objectives
Evaluate the pharmacokinetics of ceftaroline in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)
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).

Side effects data

From 2013 Phase 4 trial • 49 Patients • NCT01645735
9%
Headache
6%
Diarrhea
6%
Procedural pain
6%
Arthralgia
3%
Renal failure
3%
Non-cardiac chest pain
3%
Cardiac arrest
3%
Myocardial Infarction
3%
Clostridium difficile colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ceftaroline
Ceftriaxone Plus Vancomycin

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ceftaroline fosamilExperimental Treatment1 Intervention
Group II: IV Ceftriaxone and VancomycinActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceftaroline fosamil
FDA approved

Find a Location

Who is running the clinical trial?

Forest LaboratoriesLead Sponsor
337 Previous Clinical Trials
89,154 Total Patients Enrolled
9 Trials studying Pneumonia
2,340 Patients Enrolled for Pneumonia
~3 spots leftby Sep 2025
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