Integrated safety summary of FOCUS 1 and FOCUS 2 trials: Phase III randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with community-acquired pneumonia

Abstract

The data from the FOCUS 1 and FOCUS 2 trials presented in this integrated safety summary demonstrate that ceftaroline fosamil is well tolerated, with a tolerability profile similar to ceftriaxone and the cephalosporin class overall, with no unexpected safety concerns being identified.

An Update for Community-Acquired Bacterial Pneumonia Pharmacotherapy

“…Patients participated in scheduled laboratory visits from initiation until the TOC visit, while unscheduled laboratory visits were conducted until the LFU visit. [8][9][10] The following safety results reported are from the integrated summary of the FOCUS 1 and FOCUS 2 clinical trials. The most frequently documented TEAEs in the ceftaroline fosamil treatment group were diarrhea (4.2%), headache (3.4%), and insomnia (3.1%).…”

“…The overall incidence rates of adverse events (AEs) were consistent between the ceftaroline fosamil group and the ceftriaxone group, respectively, as follows: patients experiencing at least 1 TEAE (47.0% vs 45.7%), SAE (11.3% vs 11.7%), discontinuation due to an AE (4.4% vs 4.1%), or who died (2.4% vs 2.0%). 10 A total of 27 deaths occurred during the FOCUS trials; 15 occurred in the ceftaroline fosamil group and 12 in the ceftriaxone group. Two deaths (1 from each group) could have been related to study drug when reviewed by the investigator.…”

“…Deaths related to cardiac disorders (2 vs 7), infections and infestations (3 vs 1), neoplasms (4 vs 0), respiratory disorders (4 vs 3), and general disorders such as sudden death and multiple organ disorder (2 vs 1) occurred in the ceftaroline fosamil and ceftriaxone treatment groups, respectively. 10 There were 7 SAEs reported in more than 2 patients in the ceftaroline fosamil group, which include pneumonia (as defined by worsening or relapse of CABP or nosocomial pneumonia, 9 patients), pleural effusion (5 patients), pulmonary embolism (5 patients), chronic obstructive pulmonary disease (4 patients), pyothorax (4 patients), respiratory failure (4 patients), and malignant lung neoplasm (3 patients). The investigator reviewed the SAEs, and the majority of the SAEs (95.7% in the ceftaroline fosamil group and 91.7% in the ceftriaxone group) were regarded as not related to study drug.…”

“…Ceftaroline fosamil has a consistent safety and tolerability profile as seen with ceftriaxone and the cephalosporin class as a whole. 10,11 Clinical Efficacy…”

Antibiotics Against Endocarditis – Past, Present and Future (Experimental Data)

“…As expected, the positive control teicoplanin at 20 mg/kg IM displayed activity against the MRSA strain, with a sterilization rate of 60%, and bacterial titers similar to those observed with vancomycin against the same MRSA strain (Jacqueline et al, 2007 Ceftaroline fosamil (prodrug of the active metabolite) is a new, broad-spectrum cephalosporin recently approved in the USA for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Data from both clinical trials Wilcox et al, 2010;Rank et al, 2011) and animal studies…”