β-lactam Use in Single-stage Exchange of ProstheTic Infections (Knee / Hip) in a Center of Reference (β-SEPTIC) (β-SEPTIC)
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|ClinicalTrials.gov Identifier: NCT04123964|
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
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|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
- 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 ]
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
|Contact: Cécile RONDE-OUSTAU, MD||33 3 68 76 50 email@example.com|
|Service de Chirurgie Orthopédique Septique||Recruiting|
|Strasbourg, France, 67098|
|Contact: Cécile RONDE- OUSTAU, MD 33 3 68 76 50 62 firstname.lastname@example.org|
|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|