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Completed

NCT Number: NCT03403608

Subcutaneous Suppressive Antibiotic Therapy for Bone and Joint Infections

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.

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Key information

Conditions

Bone Infection Joint Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc Lyon)

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2018
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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