Pristinamycin in the Treatment of MSSA Bone and Joint Infection

NCT03177343 | Completed

• 1 other identifier: 69HCL17_0384
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Staphylococcus aureus represents the leading pathogen implicated in bone and joint infection (BJI), usually requiring prolonged combination antimicrobial therapy, which may be particularly challenging in the case of MDR bacteria and/or for patients with multiple drug intolerance. In the absence of new well-tolerated oral antistaphylococcal drugs, older antibiotics must be considered, such as the pristinamycin. However, pristinamycin is not currently licensed for treatment of staphylococcal BJI and lack of clinical data prevents it from being considered as a reliable alternative therapeutic option in current guidelines. The aim of this study is to evaluate pristinamycin (efficacy and tolerance) in the treatment of MSSA bone and joint infection (BJI).

Conditions

Methicillin Susceptible Staphylococcus Aureus (MSSA) Infection; Bone and Joint Infection

Keywords

Pristinamycin; Staphylococcus aureus; Bone and joint infection

Outcome Measures

Primary Outcomes (1)

• Efficacy of pristinamycin in MSSA bone and joint infection

  Outcome of patients having had pristinamycin is described in this part. The follow up of the patients after termination of antimicrobial treatment is almost 80 weeks. Treatment failure included: persisting infection under appropriate antimicrobial therapy, relapse after interruption of antimicrobial therapy, septic indication for surgical revision \> 5 days after primary surgery, superinfection; and/or death, if related to the BJI or to complication of its management.

  80 weeks

Secondary Outcomes (1)

• Tolerance of pristinamycin in MSSA bone and joint infection

  45 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients receiving pristinamycin as a part of treatment for an MSSA BJI and followed up between 2001 and 2011 in the infectious diseases department of HCL

You may qualify if:

• All patients receiving pristinamycin as a part of treatment for an MSSA BJI and followed up between 2001 and 2011 in the infectious diseases department of Hospices Civils de Lyon (HCL)

You may not qualify if:

• Patients with BJI related to diabetic foot or decubitus ulcer

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon - Hopital de la Croix Rousse - Centre de reference des infection ostéo-articulaires de Lyon

Lyon, 69004, France

Location

MeSH Terms

Conditions

Infections; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 6, 2017
• Study Start: February 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 6, 2017

Record last verified: 2017-06

Locations

FR (1)