A Phase 2/3 interventional study of Ceftaroline fosamil and Ceftriaxone in Infections and Community Acquired Pneumonia, sponsored by Forest Laboratories. Completed at 44 sites in 9 countries. Open to participants aged 2 Months to 18 Years. Per ClinicalTrials.gov, last updated 2015-01-13.
Sponsored by Forest Laboratories · Phase 2/3, Interventional, and Treatment
This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.
To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in children who are initially hospitalized with Community Acquired Bacterial Pneumonia (CABP)
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 161 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Ceftaroline fosamil · Drug: amoxicillin clavulanate
Drug: Ceftriaxone · Drug: amoxicillin clavulanate
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)
Also known as: Teflaro, PPI-0903, TAK-599, TAK599, PPI0903
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)
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.)
Evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects age 2 months to <18 years with CABP requiring hospitalization
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.
Time frame: Between 1 and 50 days.
Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to under 18 years with CABP.
* 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
Time frame: Between 4 and 50 days
To evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to under 18 years.
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).
Time frame: Between 4 and 50 days
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Forest Laboratories