What is the clinical effect of Cefideril Sulfate Injection (FETROJA)?

Cefideril sulfate injection, as an innovative antibacterial drug, has demonstrated significant efficacy in patients with Gram-negative bacterial infections in clinical trials in recent years. The drug was rigorously tested in two pivotal studies across multiple types of infections caused by Gram-negative bacteria.

In the first study of complicated urinary tract infections (cUTI), 452 adult patients were included. The results of the study showed that 73% of patients who received cefiderin sulfate injection achieved the criteria of being asymptomatic and negative in urine bacterial testing after treatment. This proportion was significantly higher than that of the control group (55%) who received a combination of imipenem and cilastin sodium. This data strongly demonstrates the excellent efficacy of cefideril sulfate injection in the treatment of complicated urinary tract infections.

The second study focused on serious infections caused by carbapenem-resistant bacteria. 152 adult patients participated in this study, and they received cefideril sulfate injection or best alternative therapy. For pulmonary infections, 50% of patients treated with cefideril sulfate injection were cured without symptoms, which was similar to the cure rate (53%) of patients receiving best alternative therapy. However, in terms of blood infections and complicated urinary tract infections, the efficacy of cefideril sulfate injection is more significant. For bloodstream infections, 44% of patients treated with cefideril sulfate injection were cured, compared with 43% of patients in the control group. For complicated urinary tract infections, 53% of patients treated with cefideril sulfate injection successfully cleared the pathogenic bacteria from their urine, compared with only 20% of patients in the control group.

In addition, cefideril sulfate injection has also shown good efficacy in the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Based on the results of the phase III APEKS-NP study, the drug met the primary endpoint in terms of all-cause mortality 14 days after starting the drug, providing clinicians with more treatment options.

In summary, cefideril sulfate injection, as an innovative antibacterial drug, has demonstrated significant efficacy and safety in the treatment of Gram-negative bacterial infections. The development and application of this drug undoubtedly brings new hope and choices to clinicians and patients.

Reference materials:https://www.drugs.com/pro/fetroja.html#S5.1