Efficacy and Safety of Dalbavancin As Suppressive Therapy

Recruiting

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

• Registration Number: NCT06899906
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-01
• Status Verified: 2025-03
• Primary Completion: 2025-03-01
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-21
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy of DAL treatment, measured as the proportion of stable infection	Outcome will be measure at 1 year. For patients lost of follow-up or followed-up less than a year, the date of last visit will be used for survival curve analysis .

Trial Locations

Locations (1)

HCL; 🇫🇷 France, Lyon, France