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

Sponsor

Forest Laboratories (Industry)

Overall Status

Completed

CT.gov ID

NCT01669980

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

1.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infections Pneumonia	Drug: Ceftaroline fosamil Drug: IV Ceftriaxone and Vancomycin	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2012

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ceftaroline fosamil	Drug: Ceftaroline fosamil 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 Other Names: Teflaro PPI-0903 TAK-599 TAK599 PPI0903
Active Comparator: IV Ceftriaxone and Vancomycin	Drug: IV Ceftriaxone and Vancomycin IV ceftriaxone 75 mg/kg/day (up to 4 g/day) divided equally every 12 hours (q12h) (± 2 hours) infused over 30 (± 10) minutes AND IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) infused over at least 60 minutes. 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

Arm

Intervention/Treatment

Experimental: Ceftaroline fosamil

Drug: Ceftaroline fosamil

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

Other Names:

Teflaro

PPI-0903

TAK-599

TAK599

PPI0903

Active Comparator: IV Ceftriaxone and Vancomycin

Drug: IV Ceftriaxone and Vancomycin

IV ceftriaxone 75 mg/kg/day (up to 4 g/day) divided equally every 12 hours (q12h) (± 2 hours) infused over 30 (± 10) minutes AND IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) infused over at least 60 minutes. 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

Outcome Measures

Primary Outcome Measures

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

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.
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Investigational Site	Long Beach	California	United States
2		Oakland	California	United States
3	Investigational Site	Orange County	California	United States
4	Investigational Site	San Diego	California	United States
5	Investigational Site	Boston	Massachusetts	United States
6	Investigational Site	Cleveland	Ohio	United States
7	Investigational Site	Toledo	Ohio	United States
8	Investigational Site	Pittsburgh	Pennsylvania	United States
9	Investigational Site	Memphis	Tennessee	United States
10		Houston	Texas	United States
11		Salt Lake City	Utah	United States
12	Investigational Site	Norfolk	Virginia	United States
13	Investigational Site	Morgantown	West Virginia	United States
14	Investigative Site	Buenos Aires		Argentina
15	Investigational Site 1	Tbilisi		Georgia
16	Investigational Site 2	Tbilisi		Georgia
17	Investigational Site 3	Tbilisi		Georgia
18	Investigational Site	Donetsk		Ukraine
19	Investigational Site	Ivano-Frankivsk		Ukraine
20	Investigational Site	Kryvyi Rih		Ukraine
21	Investigational Site	Kyiv		Ukraine