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NCT Number: NCT03177343

Pristinamycin in the Treatment of MSSA Bone and Joint Infection

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).

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Key information

Conditions

Methicillin Susceptible Staphylococcus Aureus (MSSA) Infection Bacterial Infections Bacterial Infections and Mycoses Bone and Joint Infection Gram-Positive Bacterial Infections Infections Staphylococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Lyon, 69004, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

  • 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)
  • Exclusion Criteria:
  • Patients with BJI related to diabetic foot or decubitus ulcer

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 6, 2017
Registry last updated
Jun 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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