Bone and Joint InfectionIPASTAPHNCT03750721
Staphylococcal Acute Post-Operative PJI Treated With 'DAIR' And Impact Of Rifampin
An observational study of Bone and Joint Infection and Antibiotic Resistant Staphylococcus Aureus Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
S. aureus and coagulase-negative staphylococci are the most frequent bacteria responsible for PJI (prosthetic joint infection). The aim of this study is to describe the use of rifampicin. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bone and Joint Infection, Antibiotic Resistant Staphylococcus Aureus Infection
- What is being tested?
- Role of rifampin in staphylococcal PJI
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2018to 1 May 2018
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: retrospective cohort study in 4 hospitals : patients with staphylococcal acute post-operative (< 1 month) PJI treated with DAIR in 2011-2016 period
Who may be able to join
- patients having had acute PJI (i.e. <1 month following the implantation), DAIR with exchange of removal components) due to S. aureus and coagulase-negative staphylococci (2011-2016)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Staphylococcal Acute Post-Operative Prosthetic Joint Infection Treated With 'DAIR' (Debridement and Implant Retention) And Impact Of Rifampin: A Retrospective Cohort Study In France
- aureus and coagulase-negative staphylococci are the most frequent bacteria responsible for PJI (prosthetic joint infection). The aim of this study is to describe the use of rifampicin.
- Being tested
- Role of rifampin in staphylococcal PJI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Role of rifampin in staphylococcal PJIOther
the aim is to determine if the dose and the duration of rifampin influenced the prognosis
| Study group | Role | What they receive |
|---|---|---|
| Role of rifampin in staphylococcal PJI | retrospective cohort study in 4 hospitals : patients with staphylococcal acute post-operative (< 1 month) PJI treated with DAIR in 2011-2016 period Receives: Other: Role of rifampin in staphylococcal PJI |
What is being measured
The primary outcome is the main question the study is designed to answer.
description of the use of rifampicin : rate of use
the aim is to determine how the use of rifampin influence the prognosis in staphylococcal acute post-operative prosthetic joint infection treated with DAIR
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Secondary outcomes (2)
rate of failure for treatment using rifampin
Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
rate of adverse event with rifampin
Description of adverses events leading to stop the rifampicin
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Apr 2018
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Joint 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugénie MABRUT, Hospices Civils de Lyon
- Investigators
- Tristan FERRY, Md,PhD, Principal investigator, Hospices Civils de Lyon Hôpital de la Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750721
- Sponsor's protocol ID
- 18-040
- Acronym
- IPASTAPH
- Status last verified
- Nov 2018
- First submitted
- 7 Aug 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staphylococcal Acute Post-Operative Prosthetic Joint Infection Treated With 'DAIR' (Debridement and Implant Retention) And Impact Of Rifampin: A Retrospective Cohort Study In France
- ClinicalTrials.gov ID
- NCT03750721
- Acronym / sponsor ID
- IPASTAPH / 18-040
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 23 Nov 2018 (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.
- aureus and coagulase-negative staphylococci are the most frequent bacteria responsible for PJI (prosthetic joint infection). The aim of this study is to describe the use of rifampicin.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Role of rifampin in staphylococcal PJI | – | Other: Role of rifampin in staphylococcal PJIretrospective cohort study in 4 hospitals : patients with staphylococcal acute post-operative (< 1 month) PJI treated with DAIR in 2011-2016 period |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- retrospective cohort study in 4 hospitals : patients with staphylococcal acute post-operative (< 1 month) PJI treated with DAIR in 2011-2016 period
Key inclusion criteria (1 listed)
- patients having had acute PJI (i.e. <1 month following the implantation), DAIR with exchange of removal components) due to S. aureus and coagulase-negative staphylococci (2011-2016)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Role of rifampin in staphylococcal PJIthe aim is to determine if the dose and the duration of rifampin influenced the prognosis | Other | Role of rifampin in staphylococcal PJI |
Primary outcome
description of the use of rifampicin : rate of use
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
the aim is to determine how the use of rifampin influence the prognosis in staphylococcal acute post-operative prosthetic joint infection treated with DAIR
2 secondary outcomes
rate of failure for treatment using rifampin
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
rate of adverse event with rifampin
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
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 23 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Tristan FERRY, Md,PhD principal investigator
Hospices Civils de Lyon Hôpital de la Croix-Rousse
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 Bone and Joint Infection and Antibiotic Resistant Staphylococcus Aureus 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 23 Nov 2018. 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?
description of the use of rifampicin : rate of use (time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)). 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 23 Nov 2018.