Clinical trial NCT01530763: Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)
Official title: A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone in Pediatric Subjects With Community-acquired Bacterial Pneumonia Requiring Hospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infections
Community Acquired Pneumonia
Keywords: Infections
Pediatrics
Teflaro
cephalosporin
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2012-02-10
Enrollment: 161
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 Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.

Detailed description: To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in children who are initially hospitalized with Community Acquired Bacterial Pneumonia (CABP)

Eligibility criteria: Inclusion Criteria:

* Male or female, 2 months to \< 18 years old.
* Presence of CABP requiring hospitalization and IV antibacterial therapy

Exclusion Criteria:

* Documented history of any hypersensitivity of allergic reaction to any β-lactam antimicrobial.
* Confirmed or suspected infection with a pathogen known to be resistant to ceftriaxone.
* Confirmed or suspected respiratory tract infection attributed to sources other than CABP pathogens.
* Non-infectious causes of pulmonary infiltrates.

Primary outcomes:
measure: Evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects age 2 months to <18 years with CABP requiring hospitalization
timeFrame: Between 1 and 50 days.
Secondary outcomes:
measure: Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to under 18 years with CABP.
timeFrame: Between 4 and 50 days
measure: To evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to under 18 years.
timeFrame: Between 4 and 50 days
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Investigational Site
state: California
city: Oakland
country: United States
facility: Investigational Site
state: California
city: Orange
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: Syracuse
country: United States
facility: Investigational Site
state: New York
city: Cleveland
country: United States
facility: Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Investigational Site
state: Ohio
city: Pittsuburg
country: United States
facility: Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Investigational Site
state: Utah
city: Morgantown
country: United States
facility: Investigational Site
state: West Virginia
city: Capital Federal
country: Argentina
facility: Investigational Site
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Investigational Site
city: Plovdiv
country: Bulgaria
facility: Investigational Site
city: Ruse
country: Bulgaria
facility: Investigational Site
city: Sofia
country: Bulgaria
facility: Investigational Site2
city: Sofia
country: Bulgaria
facility: Investigational Site
city: Tbilisi
country: Georgia
facility: Investigational Site2
city: Tbilisi
country: Georgia
facility: Investigational Site3
city: Tbilisi
country: Georgia
facility: Investigational Site
city: Athens
country: Greece
facility: Investigational Site
state: Attica
city: Heraklion
country: Greece
facility: Investigational Site
state: Crete
city: Thessaloniki
country: Greece
facility: Investigational Site
state: Macedonia
city: Larissa
country: Greece
facility: Investigational Site
state: Thessaly
city: Gyula
country: Hungary
facility: Investigational Site
state: Bekes
city: Ajka
country: Hungary
facility: Investigational Site
city: Budapest
country: Hungary
facility: Investigational Site
city: Nagykanisza
country: Hungary
facility: Investigational Site
city: Nyiregyhaza
country: Hungary
facility: Investigational Site
city: Szeged
country: Hungary
facility: Investigational Site
city: Veszprem
country: Hungary
facility: Investigational Site
city: Zalaegerszeg
country: Hungary
facility: Investigational Site
city: Lublin
country: Poland
facility: Investigational Site
city: Rzeszow
country: Poland
facility: Investigational Site
city: Warsaw
country: Poland
facility: Investigational Site
city: Cordoba
country: Spain
facility: Investigational Site
city: Madrid
country: Spain
facility: Investigational Site
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
city: Zaporizhia
country: Ukraine
facility: Investigational Site
Study officials:
References:
citation: Cannavino CR, Nemeth A, Korczowski B, Bradley JS, O'Neal T, Jandourek A, Friedland HD, Kaplan SL. A Randomized, Prospective Study of Pediatric Patients With Community-acquired Pneumonia Treated With Ceftaroline Versus Ceftriaxone. Pediatr Infect Dis J. 2016 Jul;35(7):752-9. doi: 10.1097/INF.0000000000001159.