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.

Study Overview

• Status: Completed
• Conditions: Bone Infection; Joint Infection

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc Lyon)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients having bone or joint infection, with or without device

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of sub-cutaneous administration of antibiotics for PSAT	In case of PSAT (prolonged suppressive antibiotic therapy), the duration could be several years. The data collected are: name of molecule, rough, posology, duration.	60 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General Publications

• Pouderoux C, Becker A, Goutelle S, Lustig S, Triffault-Fillit C, Daoud F, Fessy MH, Cohen S, Laurent F, Chidiac C, Valour F, Ferry T; Lyon Bone and Joint Infection Study Group. Subcutaneous suppressive antibiotic therapy for bone and joint infections: safety and outcome in a cohort of 10 patients. J Antimicrob Chemother. 2019 Jul 1;74(7):2060-2064. doi: 10.1093/jac/dkz104.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Infections; Communicable Diseases; Arthritis, Infectious
• Other Study ID Numbers: SSA therapy for BJI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No