Efficacy and Safety of Dalbavancin As Suppressive Therapy (DALBA-SAT)

Civil Hospices of Lyon

Status: Enrolling

Conditions: In Subjects Who Received SAT with DAL; For Acute or Chronic Infections Between July 2019 and December 2024; Efficacy and Safety of Dalbavancin

Treatments: Other: Determine patient demographic and clinical characteristics at baseline

Study type: Observational

Funder types: Other

Identifiers

NCT06899906

25-5019

Details and patient eligibility

About

Dalbavancin (DAL) is a semi-synthetic antibiotic that belongs to the lipoglycopeptide family and is structurally derived from teicoplanin, respect of which it has two structural differences that enhance its anti-staphylococcal binding affinity and extend its half-life to between 149 and 250 hours. It achieves adequate tissue penetration in the skin, bones, joints, lung tissues, and peritoneal space, maintaining concentrations above the MIC for susceptible Gram-positive pathogen.

DAL is a bactericidal antimicrobial agent that binds the C-terminal D-alanyl-D-alanine on the bacterial cell wall, blocking trans-glycosylation and transpeptidation processes essential for cell wall synthesis. It seems also to be able to enhance neutrophil antibacterial activity improving PMNs' intracellular killing of MRSA. It has also a good antibiofilm activity, alone or in combination with other molecules. Like other glycopeptide molecules, DAL shares a similar spectrum of activity, with demonstrated in vitro activity against various Gram-positive bacteria, including Staphylococcus spp, Streptococcus spp and Enterococcus (faecium, and faecalis). Resistance to DAL is possible in these gram-positives bacteria, given to presence of enzymes that produce low-affinity binding precursors for the antibiotic's binding site. DAL is capable to overcome Van-B mechanism of resistance, but it results not active in producing Van-A strains.

The study objectives was to evaluate efficacy and safety of DAL treatment.

Enrollment: 33 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 18 years
• Patients received SAT with DAL for acute or chronic infections (defined as a long-standing infection due to a previously uneradicated pathogen, following unsuccessful antibiotic or surgical treatments) between July 2019 and December 2024
• Patient who was informed and did not object to participating in the study

Exclusion criteria

• -< 18 years
• Subjects who received DAL not for SAT purposes

Trial design

33 participants in 1 patient group

Dalbavancin (DAL) as suppressive therapy (SAT)

Description:

The study population included subjects aged ≥ 18 years who received SAT with DAL for acute or chronic infections (defined as a long-standing infection due to a previously uneradicated pathogen, following unsuccessful antibiotic or surgical treatments) between July 2019 and December 2024. Subjects younger than 18 years and those who received DAL not for SAT purposes were excluded.

Treatment:

Other: Determine patient demographic and clinical characteristics at baseline