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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03611634
Other study ID # 18-126
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 19, 2018
Est. completion date July 19, 2024

Study information

Verified date August 2021
Source Hospices Civils de Lyon
Contact Eugenie mabrut
Phone 04 26 73 29 38
Email eugenie.mabrut@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date July 19, 2024
Est. primary completion date July 19, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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: - none

Study Design


Intervention

Other:
BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE
collection of saddles

Locations

Country Name City State
France Hospices Civils de Lyon Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 36 months
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