Subcutaneous Suppressive Antibiotic Therapy for Bone and Joint Infections

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03403608

Enrollment

Registered

2018-01-18

Start date

2017-03-01

Completion date

2017-08-01

Last updated

2018-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Infection, Joint Infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results