Clinical trial NCT01669980: Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)
Official title: A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone Plus Vancomycin in Pediatric Subjects With Complicated Community-acquired Bacterial Pneumonia (CABP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infections
Pneumonia
Keywords: Infections
Pediatrics
Teflaro
Ceftriaxone
cephalosporin
Vancomycin
Clindamycin
Amoxicillin Clavulanate
Linezolid
MRSA
pneumonia
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2012-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: between 1 and 57 days
Secondary outcomes:
measure: 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).
timeFrame: between 4 and 57 days
measure: Evaluate the pharmacokinetics of ceftaroline in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)
timeFrame: between 4 and 57 days
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Investigational Site
state: California
city: Oakland
country: United States
state: California
city: Orange County
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: Boston
country: United States
facility: Investigational Site
state: Massachusetts
city: Cleveland
country: United States
facility: Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: Investigational Site
state: Tennessee
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
facility: Investigational Site
state: Virginia
city: Morgantown
country: United States
facility: Investigational Site
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Investigative Site
city: Tbilisi
country: Georgia
facility: Investigational Site 1
city: Tbilisi
country: Georgia
facility: Investigational Site 2
city: Tbilisi
country: Georgia
facility: Investigational Site 3
city: Donetsk
country: Ukraine
facility: Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site
city: Kryvyi Rih
country: Ukraine
facility: Investigational Site
city: Kyiv
country: Ukraine
facility: Investigational Site
Study officials:
References: