Recurrent Campylobacter Bacteraemia in Immunocompromised Patients (CABARET)

May 22, 2024 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69004
        • Infectious diseases department, Hospital de la Croix Rousse,
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

French hospitals

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia
Time Frame: Baseline
-demographic characteristics
Baseline
Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia
Time Frame: Baseline
-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
Time Frame: Baseline
-chronic inflammatory bowel disease [IBD]
Baseline
Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia
Time Frame: Baseline
-characteristics of bacteraemia: clinical presentation, bacteria (species, antimicrobial susceptibility), secondary localizations, evolution, treatment modalities (antibiotics and immunother
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 22, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL24_0512

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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