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Bacterial Epidemiology and Empirical Antibiotherapy in Patients With Prosthetic Joint Infection

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ClinicalTrials.gov Identifier: NCT03191292
Recruitment Status : Completed
First Posted : June 19, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date April 21, 2017
First Posted Date June 19, 2017
Last Update Posted Date August 24, 2017
Actual Study Start Date June 1, 2016
Actual Primary Completion Date April 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2017)
  • identification of bacteria involved in patients with prosthetic joint infection [ Time Frame: 3 weeks after the surgery ]
    The samples collected during the surgery are put in bacteriological culture media. Bacteriological culture of samples collected during surgery for all patients included is made allowing to identify which type of bacteria is involved in the infection, depending on the chronology of the infection (delay between implantation and the presentation of the symptoms [< 1 year vs. > 1 year])
  • collection of probabilistic antibiotic treatment in patients with prosthetic joint infection [ Time Frame: the day of surgery ]
    The type of molecule used and dosage will be described. Probabilistic antibiotic treatment is initiated immediately after the surgery, before the bacteria is identified. The samples are put in bacteriological culture media. The time to obtain results is usually 3 weeks maximum after the surgery because this is the delay for slow-growing bacteria to grow. Then, the empirical treatment can be amended in order to have an antibiotic treatment adapted to the bacteria found.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03191292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 16, 2017)
  • adverse events [ Time Frame: up to 24 months after antibiotic therapy disruption ]
    This secondary outcome will focus on severe adverse events induced by this probabilistic antibiotherapy.
  • Treatment failure [ Time Frame: up to 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bacterial Epidemiology and Empirical Antibiotherapy in Patients With Prosthetic Joint Infection
Official Title Bacterial Epidemiology and Empirical Antibiotherapy in Patients With Prosthetic Joint Infection
Brief Summary

The purpose of this study is to establish a bacterial epidemiology in patients who present a prosthetic joint infection and for which a surgery is necessary. At the time of the first surgery, as the bacteria responsible for the infection are not known, a probabilistic antibiotherapy is initiated at once after the surgical treatment. The antibiotherapy is then adapted to the bacteria from samples collected during the surgery when they are identified (the delay is 14-21 days).

The study will focus on bacteria identified on samples collected during the surgery; the delay between the implantation of the prosthesis and the presentation of symptoms will be considered : more than one year vs. less than one year.

Investigators assume that there is not the same type of bacteria involved in those two cases of delays and that the probabilistic antibiotherapy may be not optimal when the symptoms are presented more than one year after implantation of the prosthesis. A probabilistic antibiotherapy not adapted lead to develop resistance for the bacteria and decrease the chance to cure the patient (increasing of relapse).

The result of this study will allow medical doctors to have an optimal probabilistic antibiotherapy, depending on the delay between implantation of the prosthesis and the presentation of the symptoms.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patient with prosthetic joint infection and treated with probabilistic antibiotherapy after a first surgery
Condition Joint Infection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 23, 2017)
567
Original Estimated Enrollment
 (submitted: June 16, 2017)
600
Actual Study Completion Date April 30, 2017
Actual Primary Completion Date April 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patient with prosthetic joint infection and treated with probabilistic antibiotherapy, between 2010 and 2015, at the Croix-Rousse Hospital

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03191292
Other Study ID Numbers 69HCL17_0306
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators
Principal Investigator: Tristan Ferry, MD Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date August 2017