Campylobacter InfectionsCAMPYLONCT02884752
Retrospective Study of Bone Infection Due to Campylobacter Spp
An observational study of Campylobacter Infections and Bone Diseases, Infectious, run by University Hospital, Brest at 1 site in France.
Trial summary
Only 24 cases of Campylobacter bone and joint infection (BJI) have been reported worldwide between 1955 and 2008. Between 2010 and 2012, 7 cases were observed in two University hospitals in France. This increasing number of cases raises several issues. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Campylobacter Infections, Bone Diseases, Infectious
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Jul 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with peroperative bone samples positive to Campylobacter spp.
Who may be able to join
- Patient with peroperative bone samples positive to Campylobacter spp. between Jan 2002 and Dec. 2012
- Adults over 18 yo
- No opposition to the study expressed by the patient
Who cannot join
- Adults below 18 yo
- Spine infection to Campylobacter spp.
- Outside of the timeframe of the study
- No microbiologic data available
- Opposition to the study expressed by the patient
Trial locations and contacts
1 site in 1 country.
About this study
Only 24 cases of Campylobacter bone and joint infection (BJI) have been reported worldwide between 1955 and 2008. Between 2010 and 2012, 7 cases were observed in two University hospitals in France. This increasing number of cases raises several issues. Are they the consequences of better detections and reporting, or are they reflecting any epidemiologic changes? For answering these questions, we performed a 10 year (2002-2012) retrospective multicenter (6 centers) study on BJI (native and implanted joints) due to Campylobacter species.
Read the detailed description
Methods: By browsing the microbiological database of 6 BJI French reference centers, we collected all cases due to Campylobacter species between 2002 and 2012, including first and relapse cases. Clinical, microbiological and treatment features were analyzed using descriptive statistics.
Results: 14 episodes of BJI due to Campylobacter spp were identified in 10 patients. Mean age was 76.8 y.o. (63-96). Sex ratio M/F was 1.5. Nine patient had hip (n=6), knee (n=2), and shoulder (n=2) implants. Immunosuppression was observed in 6 patients (3 cancers, 1 cirrhosis, 1 rheumatoid arthritis, 1 corticosteroid treatment). During the 10 primary cases: all patients had fever and 2 presented digestive symptoms. Campylobacter spp were isolated on per operative samples in 5 patients. One of them presented positive blood culture. 5 patients had joint punctures: all of them were positives. Campylobacter species were C. fetus (n=7), C. coli (n=2) and C. spp (1). Strains were resistant to nalidixic acid (=10), ciprofloxacin (n=4), erythromycin (n=3) or cefotaxime (n=2). Only one C. fetus was susceptible to all antibiotics tested. Surgical treatment was performed in 8 patients (2 two-stage procedure, 6 irrigation). The mean duration of adapted antibiotherapy was 77 days (26-237). 3 out of 4 relapse cases were due to C. fetus. All were resistant to more than one antibiotic classes.
- Medical subject headings
- Campylobacter Infections, Bone Diseases, Infectious
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of reported prosthetic joint Campylobacter spp. Infections
Measured: 1986 to 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Campylobacter InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Référence des Infections Ostéo-Articulaires du Grand Ouest
- Responsible party
- Sponsor
- Investigators
- Séverine Ansart, MD, PHD, Principal investigator, CHU Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884752
- Sponsor's protocol ID
- CAMPYLO
- Acronym
- CAMPYLO
- Status last verified
- Jul 2016
- First submitted
- 26 Aug 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Bone Infection Due to Campylobacter Spp
- ClinicalTrials.gov ID
- NCT02884752
- Acronym / sponsor ID
- CAMPYLO / CAMPYLO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Centre de Référence des Infections Ostéo-Articulaires du Grand Ouest
- Study start
- Dec 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 31 Aug 2016 (estimated)
- 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.
Only 24 cases of Campylobacter bone and joint infection (BJI) have been reported worldwide between 1955 and 2008. Between 2010 and 2012, 7 cases were observed in two University hospitals in France. This increasing number of cases raises several issues. Are they the consequences of better detections and reporting, or are they reflecting any epidemiologic changes? For answering these questions, we performed a 10 year (2002-2012) retrospective multicenter (6 centers) study on BJI (native and implanted joints) due to Campylobacter species.
Detailed description
Methods: By browsing the microbiological database of 6 BJI French reference centers, we collected all cases due to Campylobacter species between 2002 and 2012, including first and relapse cases. Clinical, microbiological and treatment features were analyzed using descriptive statistics.
Results: 14 episodes of BJI due to Campylobacter spp were identified in 10 patients. Mean age was 76.8 y.o. (63-96). Sex ratio M/F was 1.5. Nine patient had hip (n=6), knee (n=2), and shoulder (n=2) implants. Immunosuppression was observed in 6 patients (3 cancers, 1 cirrhosis, 1 rheumatoid arthritis, 1 corticosteroid treatment). During the 10 primary cases: all patients had fever and 2 presented digestive symptoms. Campylobacter spp were isolated on per operative samples in 5 patients. One of them presented positive blood culture. 5 patients had joint punctures: all of them were positives. Campylobacter species were C. fetus (n=7), C. coli (n=2) and C. spp (1). Strains were resistant to nalidixic acid (=10), ciprofloxacin (n=4), erythromycin (n=3) or cefotaxime (n=2). Only one C. fetus was susceptible to all antibiotics tested. Surgical treatment was performed in 8 patients (2 two-stage procedure, 6 irrigation). The mean duration of adapted antibiotherapy was 77 days (26-237). 3 out of 4 relapse cases were due to C. fetus. All were resistant to more than one antibiotic classes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with peroperative bone samples positive to Campylobacter spp.
Key inclusion criteria (3 listed)
- Patient with peroperative bone samples positive to Campylobacter spp. between Jan 2002 and Dec. 2012
- Adults over 18 yo
- No opposition to the study expressed by the patient
Key exclusion criteria (5 listed)
- Adults below 18 yo
- Spine infection to Campylobacter spp.
- Outside of the timeframe of the study
- No microbiologic data available
- Opposition to the study expressed by the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence rate of reported prosthetic joint Campylobacter spp. Infections
Time frame: 1986 to 2013
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 31 Aug 2016.
Related trials for Campylobacter Infections
RecruitingObservational study
Mucosal and Microbiota Changes During Acute Campylobacteriosis
Irritable Bowel Syndrome
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.
Séverine Ansart, MD, PHD principal investigator
CHU Brest
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 Campylobacter Infections and Bone Diseases, Infectious, run by University Hospital, Brest 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 3 inclusion and 5 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 31 Aug 2016. 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?
Incidence rate of reported prosthetic joint Campylobacter spp. Infections (time frame: 1986 to 2013). 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 31 Aug 2016.