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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06432777
Other study ID # 69HCL24_0512
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date May 1, 2026

Study information

Verified date May 2024
Source Hospices Civils de Lyon
Contact Anne CONRAD, Dr
Phone +33 (0)4 72 07 11 07
Email Anne.conrad@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date May 1, 2026
Est. primary completion date May 1, 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
France Infectious diseases department, Hospital de la Croix Rousse, Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia -demographic characteristics Baseline
Primary 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
Primary Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia -chronic inflammatory bowel disease [IBD] Baseline
Primary 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
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