## Protocol Section
### Identification Module
**NCT ID:** NCT06432777

**Acronym:** CABARET

**Brief Title:** Recurrent Campylobacter Bacteraemia in Immunocompromised Patients

**Official Title:** Recurrent Campylobacter Bacteraemia in Immunocompromised Patients: a Retrospective Nationwide Study in France, 2000-2025

#### Organization Study ID Info
**ID:** 69HCL24_0512
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2026-05-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-22
### 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:** Some rare cases of recurrent Campylobacter bacteraemia (RCB) exist with relapses months to years after an effective treatment and a negativation of all bacterial samples.

As of today, only around 20 cases have been described in the international literature for the last 30 years. The cases are likely highly underreported.

No study describes those recurrent Campylobacter bacteraemias at the scale of a country.

The aim of this multicentre, nationwide, retrospective study is to describe their precise epidemiology in France for the last 25 years, the immune profile of the patients, the specificities of the bacteria involved, the treatments received and the evolution of these infections.

The perspective is to propose a standardization of the medical care of those patients mainly by describing the effective treatments and the explorations of the immune system which should be considered.

### Conditions Module

**Conditions:**

- Campylobacter Infections

**Keywords:**

- primary immunodeficiency

- Campylobacter

- Relapsing bacteraemia

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients presenting at least two distinct episodes of Campylobacter bacteraemia separated by minimum 60 days and an immunodeficiency (innate or acquired)

and followed by a French hospital

**Intervention Names:**

- Other: Characteristics of patients and Campylobacter bacteraemia episodes

**Label:** Recurrent Campylobacter bacteraemia

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Recurrent Campylobacter bacteraemia

**Description:** Variables: characteristics of the patients (demographic characteristics; characteristics of immunodeficiency: diagnosis, immunoglobulin dosage, white cells count etc.; chronic inflammatory bowel disease \[IBD\]), the bacteria (species, antimicrobial susceptibility) and the infection (clinical presentation, evolution, treatment received)

**Name:** Characteristics of patients and Campylobacter bacteraemia episodes

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** -demographic characteristics

**Measure:** Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia

**Time Frame:** Baseline

**Description:** -characteristics of immunodeficiency: diagnosis, immunoglobulin dosage, white cells count, polyvalent Ig replacement therapy

**Measure:** Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia

**Time Frame:** Baseline

**Description:** -chronic inflammatory bowel disease \[IBD\]

**Measure:** Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia

**Time Frame:** Baseline

**Description:** -characteristics of bacteraemia: clinical presentation, bacteria (species, antimicrobial susceptibility), secondary localizations, evolution, treatment modalities (antibiotics and immunother

**Measure:** Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia

**Time Frame:** Baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 2 episodes or more of Campylobacter bacteraemia separated by at least 60 days
* AND immunodeficiency condition
* followed by a French hospital

Exclusion Criteria:

-Opposition of the patient

**Maximum Age:** 100 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** French hospitals

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Anne.conrad@chu-lyon.fr

**Name:** Anne CONRAD, Dr

**Phone:** +33 (0)4 72 07 11 07

**Role:** CONTACT

**Contact 2:**

**Email:** Nicolas.benech@chu-lyon.fr

**Name:** Nicolas BENECH, Dr

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Lyon

**Contacts:**

***Contact 1:***

- **Email:** Anne.conrad@chu-lyon.fr

- **Name:** Anne CONRAD, MD-PhD

- **Phone:** +33472071107

- **Role:** CONTACT

**Country:** France

**Facility:** Infectious diseases department, Hospital de la Croix Rousse,

**Zip:** 69004

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000007239

- Term: Infections

- ID: D000018805

- Term: Sepsis

- ID: D000018746

- Term: Systemic Inflammatory Response Syndrome

- ID: D000007249

- Term: Inflammation

- ID: D000010335

- Term: Pathologic Processes

- ID: D000016905

- Term: Gram-Negative Bacterial Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M18877

- Name: Bacteremia

- Relevance: HIGH

- As Found: Bacteremia

- ID: M5429

- Name: Campylobacter Infections

- Relevance: HIGH

- As Found: Campylobacter Infections

- ID: M10199

- Name: Immunologic Deficiency Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M2285

- Name: Primary Immunodeficiency Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: 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

- ID: M20864

- Name: Sepsis

- Relevance: LOW

- As Found: Unknown

- ID: M16869

- Name: Toxemia

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M20818

- Name: Systemic Inflammatory Response Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

- ID: M19249

- Name: Gram-Negative Bacterial Infections

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016470

- Term: Bacteremia

- 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: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M19117

- Name: Immunoglobulins, Intravenous

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
