CClinicalTrials.gg
Status unknownNCT03611634Updated Aug 30, 2021

Consitution Of A Biological Collection From Samples From The Gut Microbiote In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine

An observational study in Bone and Joint Infection, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-08-30.

Sponsored by Hospices Civils de Lyon · Observational

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Optimal surgical therapy (debridement in chronic osteomyelitis; device exchange in patients with chronic prosthetic joint infection [PJI]) could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening. Unfortunately, some patients are infected with resistant pathogens for which oral antibiotics are not suitable. Subcutaneous (SC) administration of injectable intravenous antibiotics as PSAT could be a convenient way to limit catheter-related complications and facilitate ambulatory care.

However, there are few data concerning the development of resistance under subcutaneous prolonged treatment with betalactamine.

The aim of this study is is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. Later analysis will be led on those samples to detect the acquisition of resistance or not.

02

Conditions studied

  • Bone and Joint Infection

Keywords

  • gut microbiote, bone and joint infection, antibiotics
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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 20 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine

Inclusion criteria

  • Patients having an ostéo-articular infection (on material or on native bone) and having an indication of antibiotic treatment suppressive subcutaneous by betalactamine and managed at the Croix-Rousse Hospital
  • Patients not opposed to participate to the study

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE

    The aim of this study is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance.

    Other: BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE

Interventions

  • OtherBIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE

    collection of saddles

06

What researchers measure

Primary outcomes

  1. BIOLOGICAL COLLECTION FROM SAMPLES FROM THE GUT MICROBIOTE

    The aim of this study is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance.

    Time frame: 36 months

07

Study locations

1 of 1 sites recruiting
  • Hospices Civils de Lyon
    Lyon, 69004, France
    • Eugenie Mabrut, CRA · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03611634
Lead sponsor
Hospices Civils de Lyon
Responsible party
Eugénie MABRUT (Clinical Research Assistant, Hospices Civils de Lyon) — Principal investigator
First posted
Aug 2, 2018
Start date
Jul 19, 2018
Primary completion
Jul 19, 2023 (estimated)
Completion
Jul 19, 2024 (estimated)
Last update
Aug 30, 2021

Study contacts

Eugenie mabrut
Contact
eugenie.mabrut@chu-lyon.fr
04 26 73 29 38
Tristan Ferry, Md,PhD
principal investigator · Hospices Civils de Lyon - Hopital de la Croix Rousse

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 Aug 2021. You cannot join it, but the record below documents what was studied.

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