Eravacycline Realizes Successful Clinical Endpoint in OPAT Facilities

Eravacycline (ERV) clinically cured a majority of patients being seen in outpatient parental antimicrobial therapy (OPAT) facilities, according to findings from a small patient population study.

ERV is a fully-synthetic, fluorocycline antibacterial with activity against Gram-negative, Gram-positive aerobic and anaerobic pathogens.

The assessment of ERV in OPAT-setting patients was led by Sara Hwang, PharmD, and a group of investigators from across the US. Their study was an accepted abstract for the 23^rd Annual Making a Difference in Infectious Disease (MAD-ID) meeting, previously canceled due to the coronavirus 2019 (COVID-19) pandemic.

Hwand and colleagues wanted to study the clinical and safety outcomes in ERV-treated patients in the OPAT clinical setting. These centers have recently emerged to deal with the ongoing challenges associated with short- or medium-to long-term parenteral therapy designed to treat persistent infections.

The team conducted a multicenter, retrospective study which included 19 patients. Comorbidities existed in 18 patients, and 13 had risk factors for resistant organisms attributed to recent hospitalizations and antibiotic exposure. In 10 patients, there were intra-abdominal infections, 6 were suffering skin and soft tissue infections, and 3 had other infections.

Investigators observed 15 baseline pathogens among 10 patients, the most common being Enterococcus spp. (n= 3), methicillin-resistant Staphylococcus aureus (n=2), Escherichia coli (n= 2) and Acinetobacter baumannii (n= 2).

The mean ERV duration was 24 (range, 4-73) days and 89.5% (17 patients) received antimicrobial therapy prior to ERV. The medication was administered at 1 mg/kg q12 hour or 1.5 mg/kg q24 hour in 10 and 9 patients, respectively.

The definition of a clinical cure was the complete resolution of signs and symptoms with no additional antibiotics required at the end of ERV therapy. This clinical endpoint was achieved in 12 patients. Another 1 of the patients achieved clinical improvement.

Conversely, 6 patients experienced clinical failure, including 3 who had to discontinue ERV due to adverse effects (AE). In terms of overall AEs, 4 patients experienced AEs with the most common ones being gastrointestinal-related events and rashes. No cases of Clostridioides difficile infection were reported.

“Clinical cure was achieved in the majority of ERV treated patients and was generally well-tolerated,” the investigators wrote. Additional investigation is warranted to fully determine the potential benefits of ERV in this treatment setting.