Subcutaneous Suppressive Antibiotic Therapy for Bone and Joint Infections

Joint Infection Clinical Trial

Official title:

Subcutaneous Suppressive Antibiotic Therapy for Bone and Joint Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03403608
• Other study ID #: SSA therapy for BJI
• Status: Completed
• Phase: N/A
• First received: November 20, 2017
• Last updated: January 10, 2018
• Start date: March 1, 2017
• Est. completion date: August 1, 2017

Study information

• Verified date: November 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Bone Infection
• Communicable Diseases
• Infection
• Joint Infection

Locations

Country	Name	City	State
France	Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc Lyon)	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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