Recurrent Campylobacter Bacteraemia in Immunocompromised Patients

NCT06432777 | Not Yet Recruiting

• 1 other identifier: 69HCL24_0512
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Campylobacter Infections

Keywords

primary immunodeficiency; Campylobacter; Relapsing bacteraemia

Outcome Measures

Primary Outcomes (4)

• Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia

  -demographic characteristics

  Baseline

• Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia

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

  Baseline

• Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia

  -chronic inflammatory bowel disease \[IBD\]

  Baseline

• Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia

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

  Baseline

Study Arms (1)

Recurrent Campylobacter bacteraemia

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

Other: Characteristics of patients and Campylobacter bacteraemia episodes

Interventions

Characteristics of patients and Campylobacter bacteraemia episodes OTHER

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)

Recurrent Campylobacter bacteraemia

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

French hospitals

You may qualify if:

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

You may not qualify if:

• Opposition of the patient

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Infectious diseases department, Hospital de la Croix Rousse,

Lyon, 69004, France

Location

MeSH Terms

Conditions

Campylobacter Infections; Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Anne CONRAD, Dr

CONTACT

+33 (0)4 72 07 11 07; Anne.conrad@chu-lyon.fr

Nicolas BENECH, Dr

CONTACT

Nicolas.benech@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 29, 2024
• Study Start: June 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)