Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ceftaroline fosamil · 3 trials · 3 indications
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
Group 1 (patient group/period 1 and 2); Group 2 (control group - healthy). Maximum plasma concentration (Cmax), time to maximum concentration (tmax), area under the plasma concentration-time curve from zero to infinity (AUC), area under the plasma concentration-time curve from zero to time of the last quantifiable concentration (AUC(0-t)), area under the plasma concentration-time curve from zero to 12 hours after the start of the infusion (AUC(0-12)), terminal rate constant (λz), terminal half-life (t1/2λz),dose normalised Cmax, dose-normalised AUC, dose-normalised AUC(0-t), and dose-normalised AUC(0-12)
Group 1 (patient group/period 2). Area under the plasma concentration -time curve from 75 min to 5.25 hr after the start of the infusion (AUC(1-5)), amount of drug extracted unchanged into the dialysate (AD) during each 1-hour interval, cumulatively, and overall (AD(1-5)) for the entire haemodialysis session (time: 75 min to 5.25 hr after the start of infusion); percent of dose recovered in dialysate (fD,%) during each 1-hour interval, cumulatively, and overall (fD(1-5),%) for the entire haemodialysis session (time: 75 min to 5.25 hr after the start of infusion), extraction coefficient (E) at each time point during haemodialysis
| Arm | Type | Description |
|---|---|---|
| Ceftaroline fosamil | EXPERIMENTAL | Patients will receive 600 mg of ceftaroline fosamil administered as a 120-minute intravenous infusion very 8 hours. Each dose will be infused in a volume of 250 mL over 120-minutes followed by aztreonam placebo in a volume of 100 mL infused over 30 minutes every 8 hours. In addition vancomycin placebo will be given in a volume of 250 mL infused over 120 minutes every 12 hours. Doses will be adjusted according to the patient's renal function. |
| Vancomycin plus aztreonam | ACTIVE_COMPARATOR | Patients will receive combination of vancomycin plus aztreonam. Dose of vancomycin will be based on the patient's actual weight and will receive intravenous vancomycin every 12 hours with each dose infused over 120-minutes. Aztreonam dose will be 1 gram intravenously in a volume of 100 mL infused over 30 minutes every 8 hours. In addition, ceftaroline fosamil placebo will be given in a volume of 250 mL infused over 120 minutes every 8 hours. Doses adjusted according to patients renal function |
| AZ drug: A | EXPERIMENTAL | 200 mg Ceftaroline fosamil 1h infusion |
| AZ drug: B | EXPERIMENTAL | 600 mg Ceftaroline fosamil 1h infusion |
| A | EXPERIMENTAL | 600 mg Ceftaroline fosamil 1 h infusion |
| B | EXPERIMENTAL | Placebo 1 h infusion |
| C | EXPERIMENTAL | 600 mg Ceftaroline fosamil 2 h infusion |
| D | EXPERIMENTAL | Placebo 2 h infusion |
| Name | Type | Description |
|---|---|---|
| Ceftaroline fosamil | DRUG | IV ceftaroline 600mg every 8 hours |
| Vancomycin | DRUG | IV vancomycin 15mg/kg every 12 hours |
| Aztreonam | DRUG | IV aztreonam 1 g every 8 hours |
| 200 mg Ceftaroline fosamil | DRUG | 1 h infusion |
| 600 mg Ceftaroline fosamil | DRUG | 1 h infusion |
| Placebo | DRUG | 1 h infusion |
Inclusion Criteria: * Male or female, aged 18 years or older * Complicated skin and skin structure infection (cSSTI) * Infection of sufficient severity to warrant hospitalization * Infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy...
Ceftaroline fosamil is an investigational small molecule being studied for complicated skin and soft tissue infections, as well as for pharmacokinetic assessment in healthy volunteers and patients with renal disease. It is being developed by Pfizer, Inc. (NYSE: PFE) and is currently in Phase 3 clinical development for infectious disease indications.
Ceftaroline fosamil is a cephalosporin antibiotic that works by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins, disrupting the cross-linking of peptidoglycan chains, which leads to bacterial cell death. This mechanism makes it effective against a range of gram-positive and gram-negative bacteria.
Ceftaroline fosamil is being developed by Pfizer, Inc., a global biopharmaceutical company headquartered in New York. Pfizer trades on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy for treating skin infections and other conditions.
Ceftaroline fosamil is in Phase 3 clinical development. The most advanced trial, NCT01499277, is a Phase 3 study comparing ceftaroline fosamil to vancomycin plus aztreonam in patients with complicated skin and soft tissue infections. This trial has been completed with 802 participants enrolled.
Ceftaroline fosamil has been studied in three completed clinical trials. NCT01499277 is a Phase 3 study in complicated skin and soft tissue infections with 802 participants. NCT01612507 is a Phase 1 healthy volunteer study with 41 participants. NCT01664065 is a Phase 1 pharmacokinetic study in end-stage renal disease patients with 15 participants.
Ceftaroline fosamil is the prodrug form of ceftaroline, the active antibiotic. Ceftaroline fosamil is converted to ceftaroline in the body after administration. The drug is being developed by Pfizer under the name ceftaroline fosamil for use in treating bacterial infections.