Infected of Hip or Kneeprosthesis Clinical Trial
— ß-SEPTICOfficial title:
Use of Probabilist Broad-spectrum β-lactam for One-stage Replacement of Infected Hip / Knee Arthroplasties: Retrospective Analysis in a Center of Reference
| NCT number | NCT04123964 |
| Other study ID # | 7368 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 27, 2019 |
| Est. completion date | June 2021 |
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
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | June 2021 |
| Est. primary completion date | June 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Chirurgie Orthopédique Septique | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Retrospective study of the use of ß-lactams in infected of hip or knee prosthesis | Files analysed retrospectily from January 1st, 2018 to December 31st, 2018 will be examined |