Pristinamycin in the Treatment of MSSA Bone and Joint Infection
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|ClinicalTrials.gov Identifier: NCT03177343|
Recruitment Status : Completed
First Posted : June 6, 2017
Last Update Posted : June 6, 2017
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).
|Condition or disease|
|Methicillin Susceptible Staphylococcus Aureus (MSSA) Infection Bone and Joint Infection|
|Study Type :||Observational|
|Actual Enrollment :||102 participants|
|Official Title:||Pristinamycin in the Treatment of MSSA Bone and Joint Infection|
|Actual Study Start Date :||February 2015|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
- Efficacy of pristinamycin in MSSA bone and joint infection [ Time Frame: 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.
- Tolerance of pristinamycin in MSSA bone and joint infection [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177343
|Hospices Civils de Lyon - Hopital de la Croix Rousse - Centre de reference des infection ostéo-articulaires de Lyon|
|Lyon, France, 69004|