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

Phase 4

Completed

• Conditions: Infections; Pneumonia
• Interventions: Drug: IV Ceftriaxone and Vancomycin; Drug: Ceftaroline fosamil

• Registration Number: NCT01669980
• Lead Sponsor: Forest Laboratories

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2012-08-17
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-21
• Study Start: 2012-10
• Primary Completion: 2014-05
• Study Completion: 2014-08
• Status Verified: 2015-10
• Disposition First Submitted: 2015-10-05
• Disposition First Submitted QC: 2015-10-05
• Last Update Submitted: 2015-10-05
• Disposition First Posted: 2015-11-01
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Ceftriaxone and Vancomycin	IV Ceftriaxone and Vancomycin	-
Ceftaroline fosamil	Ceftaroline fosamil	-

Primary Outcome Measures

Name	Time	Method
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)	between 1 and 57 days	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate the pharmacokinetics of ceftaroline in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)	between 4 and 57 days	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)
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).	between 4 and 57 days	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.

Trial Locations

Locations (5)

Investigational Site 3; 🇬🇪 Tbilisi, Georgia

Investigational Site; 🇺🇦 Kyiv, Ukraine

Investigative Site; 🇦🇷 Buenos Aires, Argentina

Investigational Site 1; 🇬🇪 Tbilisi, Georgia

Investigational Site 2; 🇬🇪 Tbilisi, Georgia