Efficacy and Safety of Dalbavancin As Suppressive Therapy

NCT ID: NCT06899906

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-05-01

Brief Summary

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Dalbavancin (DAL) as suppressive therapy (SAT)

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.

Determine patient demographic and clinical characteristics at baseline

Intervention Type: OTHER

Description of demographic data (sex, age), comorbidities (Charlson scores), septic history, and medical management (antibiotic therapy)

Interventions

Determine patient demographic and clinical characteristics at baseline

Description of demographic data (sex, age), comorbidities (Charlson scores), septic history, and medical management (antibiotic therapy)

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HCL

France, Lyon, France

Site Status: RECRUITING

Countries

France

Central Contacts

Tristan Ferry

Role: CONTACT

Tristan.ferry@chu-lyon.fr

+ 33 4 72 07 24 81

Facility Contacts

Tristan Ferry

Role: primary

Tristan.ferry@chu-lyon.fr

+ 33 4 72 07 24 81

Other Identifiers

25-5019

Identifier Type: -

Identifier Source: org_study_id