Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

β-lactam Use in Single-stage Exchange of ProstheTic Infections (Knee / Hip) in a Center of Reference (β-SEPTIC) (β-SEPTIC)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04123964
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:

According to the official recommendations, infected prosthesis can be surgically treated by one or two-stage replacement. In Strasbourg, the investigators only perform one-stage surgery, which means that the new materiel is put directly into an infected site. To prevent re-infection, probabilist antibiotherapy has to be started the earlier as possible and to have the larger specter as possible. Official recommendations don't specify the best choice of antibiotherapy and let prescriptors make choice, according to the local epidemiology and patient's history.

In Strasbourg, the investigators systematically start an antibiotic against cocci gram positive: daptomycin. Sometimes, the investigators add tazocillin, a broad-spectrum β-lactam against bacillus gram negative. To determine if the investigators use the second one, they focalized on the presence of fistula or not. Indeed, enterobacteriae from gastro-intestinal tractus are also found on the skin and can move to the peri-prosthetic site if a fistula is created. The major disadvantage of this board-spectrum antibiotic is the selection and creation of resistant bacteriae, which can be responsible of failure, re-infection, or just spreading on the environnement.

The primary purpose is to evaluate retrospectively the prescription of tazocillin, judging it's necessity thanks to antibiograms performed on samples taken during surgery. The aim is to evaluate if the criteria " fistula or not " is a good one to guide the prescription of board-spectrum β-lactam.

Secondary purposes are to find the etiology of failures ( bacteriological failure or re-infection with a new pathogen), evaluate the apparition of multi-drug resistant bacteriae and infections they are responsible for, looking for others criterias which could help the investigators to choose the probablist antibiotherapy


Condition or disease
Infected of Hip or Kneeprosthesis

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Use of Probabilist Broad-spectrum β-lactam for One-stage Replacement of Infected Hip / Knee Arthroplasties: Retrospective Analysis in a Center of Reference
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021



Primary Outcome Measures :
  1. Retrospective study of the use of β-lactams in infected of hip or knee prosthesis [ Time Frame: Files analysed retrospectily from January 1st, 2018 to December 31st, 2018 will be examined ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults ( > 18 years-old) hospitalized from 1st January 2018 to 31th December 2018 in the septic orthopedic surgery unity of the university hospital of Strasbourg for a prosthetic-joint infection (knee or hip) treated by replacement
Criteria

Inclusion Criteria:

  • Adults ( > 18 years-old) hospitalized from 1st January 2018 to 31th December 2018 in the septic orthopedic surgery unity of the university hospital of Strasbourg for a prosthetic-joint infection (knee or hip) treated by replacement.
  • Patients who mentioned they agree for scientific use of their medical data.

Exclusion Criteria:

  • Patients hospitalized only for the second surgery of a two-stage replacement.
  • Patients who refused or didn't agree with scientific use of their medical data.
  • Adults with legal protective measures.

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): NCT04123964


Contacts
Layout table for location contacts
Contact: Cécile RONDE-OUSTAU, MD 33 3 68 76 50 62 cecile.ronde-oustau@chru-strasbourg.fr

Locations
Layout table for location information
France
Service de Chirurgie Orthopédique Septique Recruiting
Strasbourg, France, 67098
Contact: Cécile RONDE- OUSTAU, MD    33 3 68 76 50 62    cecile.ronde-oustau@chru-strasbourg.fr   
Principal Investigator: Cécile RONDE- OUSTAU, MD         
Sub-Investigator: Estelle ROUGIER, MD         
Sub-Investigator: Jeannot GAUDIAS, MD         
Sub-Investigator: Carole GREUEZ, MD         
Sub-Investigator: Jean Yves JENNY, MD, PhD         
Sub-Investigator: Cyril BOERI, MD         
Sub-Investigator: François LEFEBVRE, MD         
Principal Investigator: Julien GODET, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France

Layout table for additonal information
Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04123964     History of Changes
Other Study ID Numbers: 7368
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Peri-prosthetic infection
Joint infection
One-stage replacement
Broad-spectrum β -lactam
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Lactams
beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents