Retrospective Study of Bone Infection Due to Campylobacter Spp

Campylobacter Infections Clinical Trial

— CAMPYLO  

Official title:

Retrospective Study of Bone Infection Due to Campylobacter Spp

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02884752
• Other study ID #: CAMPYLO
• Status: Completed
• Phase: N/A
• First received: August 26, 2016
• Last updated: August 26, 2016
• Start date: December 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2016
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Infectious
• Campylobacter Infections
• Communicable Diseases
• Infection
• Osteomyelitis

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Brest	Centre de Référence des Infections Ostéo-Articulaires du Grand Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of reported prosthetic joint Campylobacter spp. Infections		1986 to 2013	No