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Pristinamycin in the Treatment of MSSA Bone and Joint Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03177343
First Posted: June 6, 2017
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pristinamycin in the Treatment of MSSA Bone and Joint Infection

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.



Enrollment: 102
Actual Study Start Date: February 2015
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Criteria
  • 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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
France
Hospices Civils de Lyon - Hopital de la Croix Rousse - Centre de reference des infection ostéo-articulaires de Lyon
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03177343     History of Changes
Other Study ID Numbers: 69HCL17_0384
First Submitted: June 2, 2017
First Posted: June 6, 2017
Last Update Posted: June 6, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Pristinamycin
Staphylococcus aureus
Bone and joint infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases
Pristinamycin
Anti-Bacterial Agents
Anti-Infective Agents