Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ceftaroline · 2 trials · 3 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 | - |
| Ceftaroline q12h | EXPERIMENTAL | Ceftaroline 600mg q12h |
| Ceftaroline q8h | EXPERIMENTAL | ceftaroline 600mg q8h |
| 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 an investigational small molecule being studied for the treatment of Community-Acquired Bacterial Pneumonia (CABP) in adult hospitalized patients. It is also being evaluated in healthy volunteers for pharmacokinetic purposes. The drug is administered intravenously and is currently in Phase 3 clinical development.
Ceftaroline is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the drug's efficacy and safety in treating Community-Acquired Bacterial Pneumonia, as well as its pharmacokinetics in healthy subjects.
Ceftaroline is in Phase 3 clinical development for Community-Acquired Bacterial Pneumonia. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial has been completed, along with a Phase 1 pharmacokinetic study.
Ceftaroline has completed a Phase 3 trial (NCT01371838) comparing intravenous ceftaroline to intravenous ceftriaxone in 848 adult hospitalized patients with Community-Acquired Bacterial Pneumonia across Asia. A Phase 1 pharmacokinetic study (NCT01458743) in 24 healthy volunteers in China has also been completed.
No, Ceftaroline is not the same as ceftriaxone. Ceftaroline is the investigational drug being studied, while ceftriaxone is an active comparator used in the Phase 3 clinical trial. The trial compares the efficacy and safety of ceftaroline against ceftriaxone in treating Community-Acquired Bacterial Pneumonia.
Ceftaroline is a small molecule antibiotic. Its specific molecular target has not been disclosed in the available information. The drug is being studied for its ability to treat bacterial infections such as Community-Acquired Bacterial Pneumonia, but the precise mechanism of action is not detailed here.