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Biological Collection From Samples From The Gut Microbiota In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine (CARBAMICROBIOTA)

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ClinicalTrials.gov Identifier: NCT03550911
Recruitment Status : Not yet recruiting
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
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 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.


Condition or disease Intervention/treatment
Bone Infection Joint Infection Other: Biological Collection From Samples From The Gut Microbiota

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Constitution Of 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 (CARBAMICROBIOTA)
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Intervention Details:
  • Other: 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.


Primary Outcome Measures :
  1. Biological Collection From Samples From The Gut Microbiota [ Time Frame: 1 day ]

    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.



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.


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Ages Eligible for Study:   18 Years and older   (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 a bone or joint infection
  • Patients treated by a suppressive subcutaneous antibiotherapy with betalactamine

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): NCT03550911


Contacts
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Contact: Tristan FERRY, MD, PhD 04 72 07 11 07 ext +33 tristan.ferry@chu-lyon.fr
Contact: Eugénie MABRUT 04 26 73 29 38 ext +33 eugenie.mabrut@chu-lyon.fr

Locations
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France
Centre de référence des infections ostéo-articulaires de Lyon - Hôpital de la Croix-Rousse Not yet recruiting
Lyon, France, 69004
Contact: Tristan FERRY, MD, PhD    04 72 07 11 07 ext +33    tristan.ferry@chu-lyon.fr   
Contact: Eugénie MABRUT    04 26 73 29 38 ext +33    eugenie.mabrut@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03550911     History of Changes
Other Study ID Numbers: 69HCL18_0014
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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