CClinicalTrials.gg
Status unknownNCT04123964β-SEPTICUpdated Oct 11, 2019

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

An observational study in Infected of Hip or Kneeprosthesis, sponsored by University Hospital, Strasbourg, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-11.

Sponsored by University Hospital, Strasbourg, France · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Infected of Hip or Kneeprosthesis

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Keywords

  • Peri-prosthetic infection
  • Joint infection
  • One-stage replacement
  • Broad-spectrum β -lactam
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 100 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Service de Chirurgie Orthopédique Septique
    Strasbourg, 67098, France
    • Cécile RONDE- OUSTAU, MD · Contact · cecile.ronde-oustau@chru-strasbourg.fr · 33 3 68 76 50 62
    • Cécile RONDE- OUSTAU, MD · Principal 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 · Sub investigator
    • Julien GODET, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04123964
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Oct 11, 2019
Start date
Jun 27, 2019
Primary completion
Jun 2021 (estimated)
Completion
Jun 2021 (estimated)
Last update
Oct 11, 2019

Study contacts

Cécile RONDE-OUSTAU, MD
Contact
cecile.ronde-oustau@chru-strasbourg.fr
33 3 68 76 50 62

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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