Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03403608
Other study ID # SSA therapy for BJI
Secondary ID
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05519007 - Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone N/A
Active, not recruiting NCT04563325 - Oral-only Antibiotics for Bone and Joint Infections in Children Phase 4
Completed NCT05341908 - Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients
Recruiting NCT03550911 - Biological Collection From Samples From The Gut Microbiota In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine (CARBAMICROBIOTA)
Completed NCT04440631 - Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection
Recruiting NCT05753215 - Controlled Trial of Omadacycline Randomized Treatment Given for Bone and Joint Infection Phase 2
Recruiting NCT05137314 - Study in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA) Phase 1
Not yet recruiting NCT06293352 - Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection N/A
Recruiting NCT04304885 - Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.
Recruiting NCT03704766 - Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis N/A
Completed NCT00974493 - Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J) Phase 4
Completed NCT03191292 - Bacterial Epidemiology and Empirical Antibiotherapy in Patients With Prosthetic Joint Infection N/A
Recruiting NCT06191601 - Interest in Probabilistic Antibiotic Therapy With Broad-spectrum Beta-lactams in Orthopedic Surgery
Completed NCT05804058 - Biofilm Composition as a Predictive Biomarker for Prosthetic Joint Infection
Enrolling by invitation NCT04723940 - Or v IV Antibiotics for Infection Phase 3
Completed NCT03426761 - Dalbavancin For The Treatment of Gram Positive Osteoarticular Infections Phase 4
Enrolling by invitation NCT03713528 - Can Intraosseous Antibiotics Improve the Results of Irrigation & Debridement and Prosthetic Retention for PJI? Phase 4
Active, not recruiting NCT06402591 - Results of Extended Versus Single Dose Antibiotic Prophylaxis In Orthopedic Revision Arthroplasty in Nijmegen. Phase 3
Completed NCT04948281 - Joint Infection Following ACL Reconstruction
Completed NCT06267287 - Microbiological Structure of Pathogens of Periprosthetic Infection of Large Joints in the Post-Covid Period