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Subcutaneous Suppressive Antibiotic Therapy for Bone and Joint Infections

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ClinicalTrials.gov Identifier: NCT03403608
Recruitment Status : Completed
First Posted : January 18, 2018
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

For patients having a bone or joint infections, with or without device, optimal surgical therapy 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.

Subcutaneous (SC) administration of injectable intravenous antibiotics as prolonged suppressive antibiotic therapy could be a convenient way when oral treatment is not available to facilitate ambulatory care, this practice being considered as routine care.

The aim of this study is to evaluate tolerance and efficacy of subcutaneous administration of antibiotics for prolonged suppressive antibiotic therapy in patients having this treatment as part of their routine care.


Condition or disease
Bone Infection Joint Infection

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Subcutaneous Suppressive Antibiotic Therapy for Bone and Joint Infections
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics




Primary Outcome Measures :
  1. Description of sub-cutaneous administration of antibiotics for PSAT [ Time Frame: 60 months ]

    In case of PSAT (prolonged suppressive antibiotic therapy), the duration could be several years.

    The data collected are: name of molecule, rough, posology, duration.



Secondary Outcome Measures :
  1. Tolerance of sub-cutaneous administration of antibiotics for PSAT [ Time Frame: 60 months ]

    In case of PSAT (prolonged suppressive antibiotic therapy), the duration could be several years.

    This outcome will focus on severe adverse events induced by this sub-cutaneous and prolonged antibiotic therapy.

    Qualification of an adverse event is made using the CTCAE terminology: this terminology attributes a grade for every adverse event. There are 5 grades and a grade refers to the severity of the adverse event. A severe adverse event has a grade >=3.


  2. Efficacy of sub-cutaneous administration of antibiotics for PSAT [ Time Frame: 60 months ]
    A treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin.



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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 bone or joint infection, with or without device
Criteria

Inclusion Criteria:

  • patients having bone or joint infection,
  • patients with or without device treated by sub-cutaneous prolonged antibiotic therapy

Exclusion Criteria:

  • diabetic foot osteomyelitis
  • pressure ulcer-associated osteomyelitis

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): NCT03403608


Locations
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France
Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc Lyon)
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03403608     History of Changes
Other Study ID Numbers: SSA therapy for BJI
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: November 2017
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
Anti-Bacterial Agents
Anti-Infective Agents