Campylobacter InfectionsCABARETNCT06432777
Recurrent Campylobacter Bacteraemia in Immunocompromised Patients
An observational study of Campylobacter Infections, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Campylobacter Infections
- What is being tested?
- Characteristics of patients and Campylobacter bacteraemia episodes
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2024to 1 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: French hospitals
Who may be able to join
- 2 episodes or more of Campylobacter bacteraemia separated by at least 60 days
- AND immunodeficiency condition
- followed by a French hospital
Who cannot join
- -Opposition of the patient
Trial locations and contacts
1 site in 1 country.
Nicolas BENECH, Dr contact
France1 site
Infectious diseases department, Hospital de la Croix Rousse,
Lyon, 69004
Anne CONRAD, MD-PhD, +33472071107, Anne.conrad@chu-lyon.fr
About this study
Official title: 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.
Read more
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
- Being tested
- Characteristics of patients and Campylobacter bacteraemia episodes
- Keywords
- primary immunodeficiency, Campylobacter, Relapsing bacteraemia
- Medical subject headings
- Campylobacter Infections, Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Characteristics of patients and Campylobacter bacteraemia episodesOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Characteristics of patients and Campylobacter bacteraemia episodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia
-demographic characteristics
Measured: 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
Measured: Baseline
Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia
-chronic inflammatory bowel disease [IBD]
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Campylobacter InfectionsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432777
- Sponsor's protocol ID
- 69HCL24_0512
- Acronym
- CABARET
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Campylobacter Bacteraemia in Immunocompromised Patients: a Retrospective Nationwide Study in France, 2000-2025
- ClinicalTrials.gov ID
- NCT06432777
- Acronym / sponsor ID
- CABARET / 69HCL24_0512
- Conditions
- Campylobacter Infections
- Keywords
- primary immunodeficiency, Campylobacter, Relapsing bacteraemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent Campylobacter bacteraemia | – | Other: Characteristics of patients and Campylobacter bacteraemia episodesPatients 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 |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- French hospitals
Key inclusion criteria (3 listed)
- 2 episodes or more of Campylobacter bacteraemia separated by at least 60 days
- AND immunodeficiency condition
- followed by a French hospital
Key exclusion criteria (1 listed)
- -Opposition of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Characteristics of patients and Campylobacter bacteraemia episodesVariables: 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) | Other | Recurrent Campylobacter bacteraemia |
Primary outcome
Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia
Time frame: Baseline
-demographic characteristics
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
Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia
Time frame: Baseline
-chronic inflammatory bowel disease [IBD]
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
Related trials for Campylobacter Infections
RecruitingObservational study
Mucosal and Microbiota Changes During Acute Campylobacteriosis
Irritable Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas BENECH, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Campylobacter Infections, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne CONRAD, Dr (+33 (0)4 72 07 11 07, Anne.conrad@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.