Subcutaneous Suppressive Antibiotic Therapy for Bone and Joint Infections

Completed

• Conditions: Joint Infection; Bone Infection

• Registration Number: NCT03403608
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2017-05-01
• Study Completion: 2017-08-01
• Status Verified: 2017-11
• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2018-01-10
• Last Update Submitted: 2018-01-10
• Study First Posted: 2018-01-18
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

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Exclusion Criteria

• diabetic foot osteomyelitis
• pressure ulcer-associated osteomyelitis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of sub-cutaneous administration of antibiotics for PSAT	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

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

Trial Locations

Locations (1)

Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc Lyon); 🇫🇷 Lyon, France