Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ceftaroline · 1 trial · 2 indications
Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: •Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy •Treatment-limiting AE leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia •Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome
| Arm | Type | Description |
|---|---|---|
| Ceftaroline | EXPERIMENTAL | - |
| Ceftriaxone plus placebo | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ceftaroline | DRUG | Two consecutive infusions q12h for 5 to 7 days |
| Ceftriaxone | DRUG | One dose infusion followed by IV saline placebo infused q24h for 5 to 7 days plus two consecutive saline placebo infusion q24h. |
Inclusion Criteria: * Males and females 18 or more years of age * Lung Infection of Individual not Recently Hospitalized meeting the following criteria: Radiographically-confirmed pneumonia (new or progressive infection site of the lungs) consistent with bacterial pneumonia), AND Acute illness (≤ 7...
Ceftaroline is being developed for the treatment of community-acquired bacterial pneumonia, a lung infection in patients who have not recently been hospitalized. It is an intravenous small molecule antibacterial studied in adult hospitalized patients with this condition.
Ceftaroline is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company responsible for the clinical development of this antibacterial agent.
Ceftaroline is in Phase 3 clinical development. It is an investigational agent and has not been approved for the studied indication. The Phase 3 trial has been completed, and no active trials are currently listed.
Ceftaroline has been studied in one completed Phase 3 trial, NCT01371838. This randomized, double-blind, active-controlled study evaluated intravenous ceftaroline versus intravenous ceftriaxone in 848 adult hospitalized patients with community-acquired bacterial pneumonia across China, India, South Korea, Taiwan, and Vietnam.
Ceftaroline is a small molecule antibacterial. It is administered intravenously and is being evaluated for activity against community-acquired bacterial pneumonia in hospitalized adults.