French national cohort of first use of dalbavancin: A high proportion of off-label use

Int J Antimicrob Agents. 2019 Nov;54(5):668-672. doi: 10.1016/j.ijantimicag.2019.08.006. Epub 2019 Aug 7.

Abstract

Dalbavancin is a glycopeptide antibiotic with a long half-life, recently marketed in Europe for skin and soft-tissue infections (SSTIs), but its real-life use is not well known. The aim of this study was to describe all first prescriptions in France over an 16-month period. A retrospective study on all adult patients receiving at least one dose of dalbavancin from 1 June 2017 to 31 September 2018 was performed (75 patients from 29 French hospitals). Data were collected via a standard questionnaire. Failure was defined as persistence or reappearance of signs of infection, and/or switch to suppressive antibiotic treatment, and/or death from infection. The main indications were bone and joint infection (BJI) (64.0%), endocarditis (25.3%), and SSTI (17.3%). The main bacteria involved were Staphylococcus aureus (51.4%), including methicillin-resistant S. aureus (MRSA) (19.4%), and coagulase-negative staphylococci (44.4%). Median minimum inhibitory concentrations (MICs) for staphylococci to vancomycin and dalbavancin ranged from 0.875-2.0 mg/L and 0.032-0.064 mg/L, respectively. Dalbavancin was used after a mean of 2.3 ± 1.2 lines of antimicrobial treatment. The main treatment regimens for dalbavancin were a two-dose regimen (1500 mg each) in 38 cases (50.7%) and a single-dose regimen (1500 mg) in 13 cases (17.3%). Overall, at the patient's last visit, clinical cure was observed in 54/68 patients, whilst failure was observed in 14/68 patients. First use of dalbavancin in France was mostly off-label. Most were due to BJI, often as rescue therapy for severe infections. Even in off-label situations, dalbavancin appears safe and effective.

Keywords: Bone and joint infection; Dalbavancin; Endocarditis; Off-label; Staphylococci.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Anti-Bacterial Agents / therapeutic use*
  • Endocarditis / drug therapy*
  • Female
  • France
  • Humans
  • Male
  • Methicillin-Resistant Staphylococcus aureus / drug effects*
  • Microbial Sensitivity Tests
  • Middle Aged
  • Off-Label Use*
  • Retrospective Studies
  • Soft Tissue Infections / drug therapy*
  • Staphylococcal Infections / drug therapy*
  • Surveys and Questionnaires
  • Teicoplanin / analogs & derivatives*
  • Teicoplanin / therapeutic use
  • Treatment Outcome
  • Vancomycin / therapeutic use

Substances

  • Anti-Bacterial Agents
  • Teicoplanin
  • Vancomycin
  • dalbavancin