The simplification of the administration scheme with a hospitalized hospitalization as well as the lower risk of infections linked to a catheter failed to convince. In bacteremia at Staphylococcus aureus Complicated, dalbavancin, a long -lasting glycopeptide with only two seven -day spaces spaced by seven days, has not demonstrated its superiority in relation to conventional treatment requiring daily injections for four to six weeks.
These are the mixed results of a phase 2B randomized phase test carried out with the support of American health institutes (NIH) in 200 participants (100 in each group), while the authors counted on the improvement of the quality of life to prove their initial hypothesis. The results are published in the Jama.
Good news, however, the efficiency, one of the five items analyzed in the main composite criterion, is there with a comparable failure rate in the two groups and an identical mortality rate. Which makes Dr. John Beigel say of the Institute of Allergies and Infectious Diseases (NIAID) in a press release from NIH: “ Given the small number of antibiotics available to treat bacteremia to Staphylococcus aureus And the increase in resistance, show that dalbavancin is beneficial to take care of these severe infections gives us a new vital therapeutic alternative ”.
Authorized in skin infections and soft tissues
Dalbavancin, marketed by the Abbvie laboratory under the name of Xydalba, has already been authorized in the United States and Europe since 2015 in skin infections and soft tissues. In a 2017 notice that it renewed in 2023, the High Authority for Health has restricted its reimbursement by reserving the molecule “Only as a last resort in adult patients with infections of a certain degree of severity, for which a staphylococcal etiology is proven or suspected and that the resistance to meticillin is proven or strongly suspected”.
The Health Authority had also recommended a revision of the marketing authorization (MA) in order to clarify target population and dosage, given its duration of action (tolerance uncertainty with a 372 hour long-life) and its predictable out-of-AM use. Indeed, a post-registration study had highlighted majority use in osteoarticular infections (55 %), endocarditis and infectious arthritis (15 %) and multi-site infections (15 %).
Complicated bacteremia
In this study, the researchers used a composite criterion (known as DOOR) to 70 days including five parameters (clinical efficiency, infectious complications, non -mortal severe adverse events, adverse events, which stopped, mortality), to which was added quality of life. Dalbavancin has improved the DOOR criterion of 47.7 % with the quality of life (a figure that is weaker than without [49,3 %]), which remained below the predefined significantness threshold> 50 %.
To be included, patients had to be stabilized (negative hemocultures, disappearance of fever) before at least 72 hours of antibiotic therapy but not more than ten days. All presented a complicated bacteremia, that is to say not fulfilling the 2011 criteria of the American infectiology company defining uncomplicated bacteremia (exclusion of endocarditis, absence of prostheses, negative hemocultures between two and four days, disappearance of fever within 72 hours, absence of infections on remote sites).
The starting point for the infection was cutaneous in a third of cases, an osteoarticular infection in 27.5 % of cases, an endovascular infection in 22.5 % and a pulmonary infection in 14.5 %. Two thirds of the participants had a sensitive infection of meticillin, a third party was resistant. The results were similar in all sub-groups.
If severe adverse events were a little more numerous in the Dalbavancine group (40 versus 34), catheter infections were more in the standard group. To the surprise of the authors, the quality of life reported was similar in the two groups. A result that researchers cannot be explained: is the quality of life in case of bacteremia so degraded that perception does not change? Doesn’t the mode of administration ultimately count that much for patients? “Our results offer an additional choice for the treatment of bacteremia at S. aureus »believes Dr. Nicholas Turner, from the University of Duke (North Carolina) and the first author. To complete the comparison of the two strategies, the team currently conducts a cost/efficiency study.