NCT03403608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
Last Updated

January 18, 2018

Status Verified

November 1, 2017

Enrollment Period

2 months

First QC Date

November 20, 2017

Last Update Submit

January 10, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Tolerance of sub-cutaneous administration of antibiotics for PSAT

    60 months

  • Efficacy of sub-cutaneous administration of antibiotics for PSAT

    60 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients having bone or joint infection, with or without device

You may qualify if:

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

You may not qualify if:

  • diabetic foot osteomyelitis
  • pressure ulcer-associated osteomyelitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc Lyon)

Lyon, 69004, France

Location

Related Publications (1)

  • 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 Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

January 18, 2018

Study Start

March 1, 2017

Primary Completion

May 1, 2017

Study Completion

August 1, 2017

Last Updated

January 18, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations