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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

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ClinicalTrials.gov Identifier: NCT03611634
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Eugénie MABRUT, Hospices Civils de Lyon

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 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.


Condition or disease Intervention/treatment
Bone and Joint Infection Other: BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : July 19, 2021
Estimated Study Completion Date : July 19, 2021

Group/Cohort Intervention/treatment
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
collection of saddles




Primary Outcome Measures :
  1. BIOLOGICAL COLLECTION FROM SAMPLES FROM THE GUT MICROBIOTE [ Time Frame: 36 months ]
    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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611634


Contacts
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Contact: Eugenie mabrut 04 26 73 29 38 eugenie.mabrut@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon Recruiting
Lyon, France, 69004
Contact: Eugenie Mabrut, CRA         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Tristan Ferry, Md,PhD Hospices Civils de Lyon - Hopital de la Croix Rousse

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Responsible Party: Eugénie MABRUT, Clinical Research Assistant, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03611634     History of Changes
Other Study ID Numbers: 18-126
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eugénie MABRUT, Hospices Civils de Lyon:
gut microbiote, bone and joint infection, antibiotics

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases