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Trial record 39 of 47 for:    "Prosthetic Joint Infection"

Staphylococcal Acute Post-Operative PJI Treated With 'DAIR' And Impact Of Rifampin (IPASTAPH)

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.
ClinicalTrials.gov Identifier: NCT03750721
Recruitment Status : Completed
First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Eugénie MABRUT, Hospices Civils de Lyon

Brief 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.

Condition or disease Intervention/treatment
Bone and Joint Infection Antibiotic Resistant Staphylococcus Aureus Infection Other: Role of rifampin in staphylococcal PJI

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Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rifampin

Group/Cohort Intervention/treatment
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
Other: Role of rifampin in staphylococcal PJI
the aim is to determine if the dose and the duration of rifampin influenced the prognosis




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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) ]
    Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin

  2. 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) ]
    Description of adverses events leading to stop the rifampicin



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
retrospective cohort study in 4 hospitals : patients with staphylococcal acute post-operative (< 1 month) PJI treated with DAIR in 2011-2016 period
Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

None


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): NCT03750721


Locations
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France
Hospices Civils de Lyon
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Tristan FERRY, Md,PhD Hospices Civils de Lyon Hôpital de la Croix-Rousse

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Responsible Party: Eugénie MABRUT, Clinical Research Assistant, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03750721     History of Changes
Other Study ID Numbers: 18-040
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Staphylococcal Infections
Arthritis
Joint Diseases
Musculoskeletal Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Rifampin
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers