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4CPS-026 Dalbavancin off-label use: effectiveness and safety
  1. M Arrieta,
  2. JM Caro-Teller,
  3. S Ortiz-Pérez,
  4. C Rosas-Espinoza,
  5. MD Canales-Siguero,
  6. F Martínez De La Torre,
  7. JM Ferrari-Piquero
  1. Hospital Universitario 12 De Octubre, Pharmacy, Madrid, Spain


Background and importance Dalbavancin is approved for treating complicated skin and soft tissue infections. However, there is growing evidence that other severe gram positive infections could be treated with this antibiotic.

Aim and objectives To evaluate the use of dalbavancin in a tertiary hospital in Spain, as well as its effectiveness and safety for off-label indications.

Material and methods A retrospective observational study was carried out including all patients treated with dalbavancin in our hospital (October 2016–June 2019). Demographic, clinical and safety variables were collected. Effectiveness was assessed by the clinical and microbiological resolution of the infection, and the absence of hospital admissions due to the same infection in the following 3 months after receiving dalbavancin.

Results Ninety-two patients received treatment during the period of the study (70.7% men, n=65; median age 69.1±15.0 years). In 64 cases (69.6%) the treatment was off-label: bacteraemia (68.7%, n=44), endocarditis (18.8%, n=12), osteomyelitis (9.4%, n=6) and septic arthritis (3.1%, n=2).

Infections were caused by: Staphylococcus aureus (68.9%, n=44), Enterococcus (14.2%, n=9), empiric (6.3%, n=4), Staphylococcus epidermidis (3.1%, n=2), Staphylococcus lugdunensis (1.5%, n=1), coagulase negative Staphylococcus (1.5%, n=1), Staphylococcus haemolyticus (1.5%, n=1), Streptococcus oralis (1.5%, n=1) and Streptococcus gordonii (1.5%, n=1).

All patients had previously received antibiotics. Reasons for switching to dalbavancin were: patient discharge (85.9%, n=55) and toxicity caused by the previous antibiotic therapy (14.1%, n=9).

Dosage was: 1500 mg single dose (79.8%, n=51), 1500 mg on days 0 and 15 (11.0%, n=7), 1500 mg on day 0 and 500 mg on day 15 (3.2%, n=2), 1000 mg on day 0 and 500 mg on day 7 (1.5%, n=1), 1500 mg every 15 days: 3 times (1.5%, n=1), 4 times (1.5%, n=1) and 7 times (1.5%, n=1).

The first doses were administered during hospitalisation and the following doses, if required, in the outpatient setting. Length of hospital stay was reduced to 18.9±10.7 days/patient.

A total of 92.2% of patients (n=59) presented clinical and microbiological resolution of the infection at the end of treatment. However, five patients were readmitted for treatment of the same infection during the follow-up period. Serious adverse effects related to dalbavancin were not reported.

Conclusion and relevance In most of our patients, dalbavancin was used off-label. Our results suggest that dalbavancin is a safe and effective alternative in the treatment of gram positive infections. Its dosage facilitates an early discharge and outpatient management of these patients.

References and/or acknowledgements No conflict of interest.

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