Advisory statement on likely place in therapy

Advisory statement on likely place in therapy

Eravacycline may be an option for treating complicated intra-abdominal infections in adults with limited treatment options when standard intravenous antibiotics are not suitable or have been ineffective. Take account of local antimicrobial resistance and seek specialist microbiological advice. Follow recommendations on new antimicrobials in the NICE guideline on antimicrobial stewardship.

Rationale

The European public assessment report (EPAR) on eravacycline states that complicated intra-abdominal infections are the second most common cause of morbidity and mortality, after pneumonia in adults, in the intensive care unit. They are characterised by an increased mortality because of both the underlying patient health status and the increased likelihood of infection caused by multi‑drug resistant organisms. The pathogens most frequently seen in complicated intra-abdominal infections include the Gram-negative bacteria Escherichia coli and other common Enterobacteriaceae, Pseudomonas aeruginosa and Bacteroides fragilis. Second or third generation cephalosporins in combination with metronidazole; beta-lactam antibiotics (such as penicillins) in combination with beta-lactamase inhibitors; and carbapenems are commonly used for treating complicated intra-abdominal infections. Effective management of complicated intra-abdominal infection requires early diagnosis, appropriate surgical intervention and empiric, broad-spectrum antimicrobial treatment.

Evidence from 2 phase 3 randomised controlled trials in non-UK hospitals (n=541 and n=500) found that eravacycline was non-inferior to either ertapenem or meropenem for treating complicated intra-abdominal infections in adults. Eravacycline was administered every 12 hours. Treatment duration was a minimum of four 24-hour dosing cycles. The infections treated in the studies were complicated intra-abdominal infections which included complicated appendicitis, cholecystitis, gastric perforation and peritonitis.

Increasing resistance to commonly prescribed antimicrobial agents is a recognised serious global problem (EPAR report). Eravacycline offers an alternative for treating complicated intra-abdominal infections.

The NICE guideline on antimicrobial stewardship makes recommendations on the effective use of new antimicrobials. Eravacycline should be reserved for those people most likely to benefit from it, after specialist microbiological advice to help monitor use and limit antimicrobial resistance.