Pristinamycin in the Treatment of MSSA Bone and Joint Infection

Bone and Joint Infection Clinical Trial

Official title:

Pristinamycin in the Treatment of MSSA Bone and Joint Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03177343
• Other study ID #: 69HCL17_0384
• Status: Completed
• Phase: N/A
• First received: June 2, 2017
• Last updated: June 2, 2017
• Start date: February 2015
• Est. completion date: August 2015

Study information

• Verified date: June 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Bone and Joint Infection
• Communicable Diseases
• Infection
• Methicillin Susceptible Staphylococcus Aureus (MSSA) Infection

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hopital de la Croix Rousse - Centre de reference des infection ostéo-articulaires de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tolerance of pristinamycin in MSSA bone and joint infection	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.	45 weeks