NCT03550911

Brief 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 prolonged suppressive antibiotic therapy 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 just to constitute a biological collection from samples from the Gut microbiota 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

October 11, 2018

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2024

Completed
Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

5.5 years

First QC Date

May 28, 2018

Last Update Submit

December 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Biological Collection From Samples From The Gut Microbiota

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

    1 day

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de référence des infections ostéo-articulaires de Lyon - Hôpital de la Croix-Rousse

Lyon, 69004, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biological collection from samples from the GUT microbiota in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2018

First Posted

June 8, 2018

Study Start

October 11, 2018

Primary Completion

April 8, 2024

Study Completion

April 8, 2024

Last Updated

December 9, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations