## Protocol Section
### Identification Module
**NCT ID:** NCT06425250

**Acronym:** Campylo-BJI

**Brief Title:** Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study

**Official Title:** Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study

#### Organization Study ID Info
**ID:** 69HCL23_5284
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-04-01

**Type:** ACTUAL

#### Start Date
**Date:** 2024-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospices Civils de Lyon

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Campylobacter bacteria, a Gram-negative bacillus commensal in the digestive tract of many animals and mainly responsible for human infections with digestive origins, has been little studied in the field of osteoarticular infections (OAI). Campylobacter spp. are, however, well described, mainly for C. fetus, and pose a dual therapeutic problem: i) a capacity for persistence due to the capacity of most strains to form biofilm; and ii) potential resistance to many antibiotics. The management of IOA caused by Campylobacter spp. is not codified, and is based on small series of cases reported in the literature.

### Conditions Module

**Conditions:**

- Campylobacter Infections

**Keywords:**

- Management

- Risk factors

- Campylobacter spp.

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Adult patients treated for prosthetic joint infection caused by Campylobacter spp. between 01/01/2013 and 12/31/2022

**Intervention Names:**

- Other: Management, progression and risk factors for failure of BJI caused by Campylobacter spp.

- Other: Description of the evolution and risk factors for failure of osteoarticular infections caused by Campylobacter spp.

**Label:** Management, progression and risk factors for failure of BJI caused by Campylobacter spp.

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Management, progression and risk factors for failure of BJI caused by Campylobacter spp.

**Description:** Description of demographic data (sex, age), comorbidities (ASA and Charlson scores), orthopedic and septic history, and surgical and medical management (antibiotic therapy)

**Name:** Management, progression and risk factors for failure of BJI caused by Campylobacter spp.

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Management, progression and risk factors for failure of BJI caused by Campylobacter spp.

**Description:** Failure of treatment: defined according to a composite criterion bringing together

* persistence of the infection under treatment, and/or
* recurrence of the infection after stopping antibiotic therapy, and/or
* need for surgical revision for septic reasons more than 5 days after initial treatment, and/or
* superinfection, and/or
* definitive explantation of the material, and/or
* decision for suppressive antibiotic therapy, and/or
* amputation, and/or
* death linked to infection

**Name:** Description of the evolution and risk factors for failure of osteoarticular infections caused by Campylobacter spp.

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Treatment failure will be defined as: i) infection persistence under appropriate antimicrobial therapy; ii) infection relapse; iii) need for unplaned surgery; iv) superinfection and/or v) infection-related death

**Measure:** Outcome of Campylobacter spp. BJI, measured as the proportion of treatment failure.

**Time Frame:** Outcome will be measure at 1 year. For patients lost of follow-up or followed-up less than a year, the date of last visit will be used for survival curve analysis .

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* \> 18 years
* Osteoarticular infection (whatever its type), mono or polymicrobial with Campylobacter spp., diagnosed between 01/01/2013 and 12/31/2022:
* Septic arthritis: compatible clinical signs + joint fluid sample positive in culture and/or PCR positive for Campylobacter
* Spondylodiscitis: clinical signs and MRI compatible + blood cultures and/or disco-vertebral biopsy puncture positive in culture and/or PCR positive for Campylobacter
* Osteitis/osteomyelitis: compatible clinico-radiological picture + bone sample (biopsy or intraoperative sample) positive in culture and/or positive PCR for Campylobacter
* Infection on joint prosthesis or osteosynthesis equipment: documented Campylobacter infection and meeting the definition of probable or confirmed JIBS infections
* Patient who was informed and did not object to participating in the study

Exclusion Criteria:

-

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult patients treated for prosthetic joint infection caused by Campylobacter spp. between 01/01/2013 and 12/31/2022

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lyon

**Contacts:**

***Contact 1:***

- **Email:** florent.valour@chu-lyon.fr

- **Name:** Florent VALOUR, Dr

- **Phone:** 04 72 07 11 07

- **Phone Ext:** +33

- **Role:** CONTACT

**Country:** France

**Facility:** Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse

**Status:** RECRUITING

**Zip:** 69317

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000016905

- Term: Gram-Negative Bacterial Infections

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M5429

- Name: Campylobacter Infections

- Relevance: HIGH

- As Found: Campylobacter Infections

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M19249

- Name: Gram-Negative Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000002169

- Term: Campylobacter Infections

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M16759

- Name: Tin Fluorides

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
