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

Sponsor

Forest Laboratories (Industry)

Overall Status

Completed

CT.gov ID

NCT01530763

Collaborator

AstraZeneca (Industry)

161

Enrollment

Locations

Arms

21.9

Duration (Months)

3.7

Patients Per Site

0.2

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 Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.

Condition or Disease	Intervention/Treatment	Phase
Infections Community Acquired Pneumonia	Drug: Ceftaroline fosamil Drug: Ceftriaxone Drug: amoxicillin clavulanate	Phase 2/Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

161 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 in Pediatric Subjects With Community-acquired Bacterial Pneumonia Requiring Hospitalization

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ceftaroline fosamil	Drug: Ceftaroline fosamil Treatment Group 1: Drug: Ceftaroline fosamil Children ≥ 6 months: IV ceftaroline fosamil 12 mg/kg for subjects weighing ≤ 33 kg or 400 mg for subjects weighing > 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) Children < 6 months: Ceftaroline fosamil 8 mg/kg over 60 (± 10) minutes q8h (± 1 hour) Other Names: Teflaro PPI-0903 TAK-599 TAK599 PPI0903 Drug: amoxicillin clavulanate Oral Switch for Treatment Groups 1 and 2: PO amoxicillin clavulanate 90 mg/kg/day divided q12h in subjects with infections due to susceptible organisms on or after Study Day 4 (a minimum of 7 IV doses required if randomized to ceftaroline.)
Active Comparator: Ceftriaxone	Drug: Ceftriaxone Treatment group 2: 75 mg/kg/day up to 4 g/day IV in equally divided doses, each infused over 30 (± 10) minutes q12hr (± 2 hours) Drug: amoxicillin clavulanate Oral Switch for Treatment Groups 1 and 2: PO amoxicillin clavulanate 90 mg/kg/day divided q12h in subjects with infections due to susceptible organisms on or after Study Day 4 (a minimum of 7 IV doses required if randomized to ceftaroline.)

Arm

Intervention/Treatment

Experimental: Ceftaroline fosamil

Drug: Ceftaroline fosamil

Treatment Group 1: Drug: Ceftaroline fosamil Children ≥ 6 months: IV ceftaroline fosamil 12 mg/kg for subjects weighing ≤ 33 kg or 400 mg for subjects weighing > 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) Children < 6 months: Ceftaroline fosamil 8 mg/kg over 60 (± 10) minutes q8h (± 1 hour)

Other Names:

Teflaro

PPI-0903

TAK-599

TAK599

PPI0903

Drug: amoxicillin clavulanate

Oral Switch for Treatment Groups 1 and 2: PO amoxicillin clavulanate 90 mg/kg/day divided q12h in subjects with infections due to susceptible organisms on or after Study Day 4 (a minimum of 7 IV doses required if randomized to ceftaroline.)

Active Comparator: Ceftriaxone

Drug: Ceftriaxone

Treatment group 2: 75 mg/kg/day up to 4 g/day IV in equally divided doses, each infused over 30 (± 10) minutes q12hr (± 2 hours)

Drug: amoxicillin clavulanate

Outcome Measures

Primary Outcome Measures

Evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects age 2 months to <18 years with CABP requiring hospitalization [Between 1 and 50 days.]
Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with CABP. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology studies, comprehensive and metabolic panel), vital signs.

Secondary Outcome Measures

Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to under 18 years with CABP. [Between 4 and 50 days]
Clinical response by subject and by baseline pathogen at Study Day 4 in the Modified Intent-to-Treat (MITT) and Microbiological modified Intent-to Treat (mMITT) Populations Clinical stability by subject and by baseline pathogen at Study Day 4 in the MITT and mMITT Populations Clinical outcome at EOIV, EOT, and TOC in the MITT and Clinically Evaluable (CE) Populations Clinical and microbiological outcomes by subject and by pathogen at TOC in the mMITT and Microbiologically Evaluable (ME) Populations Clinical relapse at LFU in the MITT Population Emergent infections in the mMITT Population
To evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to under 18 years. [Between 4 and 50 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Investigational Site	Long Beach	California	United States
2	Investigational Site	Oakland	California	United States
3	Investigational Site	Orange	California	United States
4	Investigational Site	San Diego	California	United States
5	Investigational Site	Boston	Massachusetts	United States
6	Investigational Site	Syracuse	New York	United States
7	Investigational Site	Cleveland	Ohio	United States
8	Investigational Site	Toledo	Ohio	United States
9	Investigational Site	Pittsuburg	Pennsylvania	United States
10	Investigational Site	Memphis	Tennessee	United States
11	Investigational Site	Houston	Texas	United States
12	Investigational Site	Salt Lake City	Utah	United States
13	Investigational Site	Morgantown	West Virginia	United States
14	Investigational Site	Capital Federal	Buenos Aires	Argentina
15	Investigational Site	Cordoba		Argentina
16	Investigational Site	Plovdiv		Bulgaria
17	Investigational Site	Ruse		Bulgaria
18	Investigational Site2	Sofia		Bulgaria
19	Investigational Site	Sofia		Bulgaria
20	Investigational Site2	Tbilisi		Georgia
21	Investigational Site3	Tbilisi		Georgia
22	Investigational Site	Tbilisi		Georgia
23	Investigational Site	Athens	Attica	Greece
24	Investigational Site	Heraklion	Crete	Greece
25	Investigational Site	Thessaloniki	Macedonia	Greece
26	Investigational Site	Larissa	Thessaly	Greece
27	Investigational Site	Gyula	Bekes	Hungary
28	Investigational Site	Ajka		Hungary
29	Investigational Site	Budapest		Hungary
30	Investigational Site	Nagykanisza		Hungary
31	Investigational Site	Nyiregyhaza		Hungary
32	Investigational Site	Szeged		Hungary
33	Investigational Site	Veszprem		Hungary
34	Investigational Site	Zalaegerszeg		Hungary
35	Investigational Site	Lublin		Poland
36	Investigational Site	Rzeszow		Poland
37	Investigational Site	Warsaw		Poland
38	Investigational Site	Cordoba		Spain
39	Investigational Site	Madrid		Spain
40	Investigational Site	Donetsk		Ukraine
41	Investigational Site	Ivano-Frankivsk		Ukraine
42	Investigational Site	Kryvyi Rih		Ukraine
43	Investigational Site	Kyiv		Ukraine
44	Investigational Site	Zaporizhia		Ukraine