Safety and Efficacy Study of Ceftaroline Versus a Compara... | NCT01669980

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)

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Ceftaroline fosamil	Experimental		Drug: Ceftaroline fosamil
IV Ceftriaxone and Vancomycin	Active Comparator		Drug: IV Ceftriaxone and Vancomycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ceftaroline fosamil	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	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.	between 1 and 57 days

Secondary Outcomes

Measure	Description	Time Frame
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).	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.

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site		Long Beach	California		United States

Label	URL
Sponsor Homepage	View source

ID	Term
D007239	Infections
D011014	Pneumonia

ID	Term
D012141	Respiratory Tract Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D000097583	Ceftaroline
D002443	Ceftriaxone
D014640	Vancomycin

Ancestor Terms

ID	Term
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930	Organic Chemicals
D013843	Thiazines
D013457	Sulfur Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D002439	Cefotaxime
D002505	Cephacetrile
D006020	Glycopeptides
D006001	Glycoconjugates
D002241	Carbohydrates
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins