Antibiotic ReactionNCT03848104
Evaluation of the Use of Cefoxitin in Combination in Continuous Parenteral Administration in the Treatment of Bone and Joint Infections
An observational study of Antibiotic Reaction and Bone and Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Antibiotic Reaction, Bone and Joint Infection
- What is being tested?
- bone and joint infection treated with cefoxitin
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 1 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- patients havind had a bon and joint infeciton treated with cefoxitin in combination in continuous parenteral administration
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Antibiotic Reaction, Bone and Joint Infection
- Being tested
- bone and joint infection treated with cefoxitin
- Keywords
- cefoxitin, Bone and Joint Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone and joint infection treated with cefoxitinOther
the patients had cefoxitin in combination in continuous parenteral administration to treat their bone / joint infection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: bone and joint infection treated with cefoxitin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Descriptions of patients managed with this strategy
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Jan 2018
- Primary completion1 Mar 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic ReactionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugénie MABRUT, Hospices Civils de Lyon
- Investigators
- Tristan Ferry, Md,PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848104
- Sponsor's protocol ID
- 18-079
- Status last verified
- Feb 2019
- First submitted
- 19 Feb 2019
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Cefoxitin in Combination in Continuous Parenteral Administration in the Treatment of Bone and Joint Infections
- ClinicalTrials.gov ID
- NCT03848104
- Acronym / sponsor ID
- 18-079
- Conditions
- Antibiotic Reaction, Bone and Joint Infection
- Keywords
- cefoxitin, Bone and Joint Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bone and joint infection treated with cefoxitin | – | Other: bone and joint infection treated with cefoxitinpatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- patients havind had a bon and joint infeciton treated with cefoxitin in combination in continuous parenteral administration
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone and joint infection treated with cefoxitinthe patients had cefoxitin in combination in continuous parenteral administration to treat their bone / joint infection | Other | bone and joint infection treated with cefoxitin |
Primary outcome
Rate of Treatment Failure
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin
1 secondary outcome
Rate of use of this strategy
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tristan Ferry, Md,PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Reaction and Bone and Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Treatment Failure (time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.