Methicillin Susceptible Staphylococcus Aureus (MSSA) InfectionNCT03177343
Pristinamycin in the Treatment of MSSA Bone and Joint Infection
An observational study of Methicillin Susceptible Staphylococcus Aureus (MSSA) Infection and Bone and Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methicillin Susceptible Staphylococcus Aureus (MSSA) Infection, Bone and Joint Infection
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- Patients with BJI related to diabetic foot or decubitus ulcer
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Hopital de la Croix Rousse - Centre de reference des infection ostéo-articulaires de Lyon
Lyon, 69004
About this study
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).
- Keywords
- Pristinamycin, Staphylococcus aureus, Bone and joint infection
- Medical subject headings
- Infections, Staphylococcal Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 80 weeks
Secondary outcomes (1)
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.
Measured: 45 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study startFeb 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methicillin Susceptible Staphylococcus Aureus (MSSA) InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177343
- Sponsor's protocol ID
- 69HCL17_0384
- Status last verified
- Jun 2017
- First submitted
- 2 Jun 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pristinamycin in the Treatment of MSSA Bone and Joint Infection
- ClinicalTrials.gov ID
- NCT03177343
- Acronym / sponsor ID
- 69HCL17_0384
- Keywords
- Pristinamycin, Staphylococcus aureus, Bone and joint infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients with BJI related to diabetic foot or decubitus ulcer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Tolerance of pristinamycin in MSSA bone and joint infection
Time frame: 45 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Methicillin Susceptible Staphylococcus Aureus (MSSA) Infection and Bone and Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of pristinamycin in MSSA bone and joint infection (time frame: 80 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.