NCT03848104

Brief Summary

Cephamycin related to 2nd generation cephalosporins, the use of cefoxitin has long been limited to antibiotic prophylaxis. Because of its spectrum (sensitive staphylococci, enterobacteria including ESBL, streptococci, anaerobes), its stability and its low cost, it could be useful in curative bone and joint infections, especially in case of infection polymicrobial disease in patients for whom antibiotic alternative per os is limited.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

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

January 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

February 19, 2019

Last Update Submit

February 20, 2019

Conditions

Keywords

cefoxitinBone and Joint Infection

Outcome Measures

Primary Outcomes (1)

  • Rate of Treatment Failure

    Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin

    Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

Secondary Outcomes (1)

  • Rate of use of this strategy

    Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption

Study Arms (1)

bone and joint infection treated with cefoxitin

patients having had a bone or joint infection treated by cefoxitin in combination. Cefoxitin has been administered by continuous way, at home. A serum dosage of cefoxitin has been systematically achieved at equilibrium.

Other: bone and joint infection treated with cefoxitin

Interventions

the patients had cefoxitin in combination in continuous parenteral administration to treat their bone / joint infection

bone and joint infection treated with cefoxitin

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients havind had a bon and joint infeciton treated with cefoxitin in combination in continuous parenteral administration managed at the Croix-Rousse Hospital

You may qualify if:

  • patients havind had a bon and joint infeciton treated with cefoxitin in combination in continuous parenteral administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

Location

MeSH Terms

Interventions

Cefoxitin

Intervention Hierarchy (Ancestors)

CephamycinsCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Tristan Ferry, Md,PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical research assistant

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 20, 2019

Study Start

January 1, 2018

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations