Pristinamycin in the Treatment of MSSA Bone and Joint Infection

Completed

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

• Registration Number: NCT03177343
• Lead Sponsor: Hospices Civils de Lyon

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2017-06
• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-02
• Last Update Submitted: 2017-06-02
• Study First Posted: 2017-06-06
• Last Update Posted: 2017-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• 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)

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Exclusion Criteria

• Patients with BJI related to diabetic foot or decubitus ulcer

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of pristinamycin in MSSA bone and joint infection	80 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Tolerance of pristinamycin in MSSA bone and joint infection	45 weeks	The treatment duration could be long (several weeks) as pristinamycin is also used as a long-term suppressive therapy in BJI; thus, we can have 45 weeks of treatment with pristinamycin.; Pristinamycin-related adverse events (AEs) occurring during follow-up were noted and classified according to the Common Terminology Criteria for Adverse Events (CTCAE; National Cancer Institute, 2003). The accountability of pristinamycin in AE onset was left to the clinician's judgement, with the help of a pharmacovigilance specialist in doubtful cases.

Trial Locations

Locations (1)

Hospices Civils de Lyon - Hopital de la Croix Rousse - Centre de reference des infection ostéo-articulaires de Lyon; 🇫🇷 Lyon, France