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NCT Number: NCT05798247

Cutaneous Diphtheria in France : Observational, Retrospective Study of Patient Characteristics

Toxigenic cutaneous diphtheria is a notifiable disease that is re-emerging in the world and particularly in France. A better description of the epidemiological characteristics, as well as a refinement of the clinical characteristics of patients with cutaneous diphtheria, are essential to better understand this pathology, which has important public health issues and whose diagnosis absence can have catastrophic consequences for the patient and their contacts. Microbiological data (species identification, toxigenicity or not, resistance profile...) will be transmitted by the national reference center for corynebacteria of the diphtheriae complex and then caregivers who have managed the corresponding patients with cutaneous diphtheria will be contacted.

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Key information

Conditions

Corynebacterium Diphtheriae Infection Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Corynebacterium Infections Diphtheria Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Hospitalo-Universitaire de Marseille, Marseille, Bouches-du-Rhône, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Culture or PCR positive skin samples for corynebacteria diphtheria, ulcerans, pseudotuberculosis, belfantii or rouxii
  • Patient living in metropolitan France

Exclusion criteria

  • Patient opposition

Treatment and study plan

Characteristics description

Other

Caregivers who follow the patients of the study group will be contacted to collect these patients clinical and epidemiological characteristics

Primary outcomes

  1. Patients epidemiological data description

    Time frame: 3 months

    Epidemiological data will be collected to describe the studied population (age, sex, place of birth, vaccination status...)

  2. Patients clinical data description

    Time frame: 3 months

    Clinical data will be collected to describe the studied population (history, description of lesions, disease evolution, complications...)

  3. Patients microbiological data description

    Time frame: 3 months

    Microbiological data will be collected to describe the studied population (species identification, toxigenicity, presence of a co-infection...)

  4. Patients therapeutic data description

    Time frame: 3 months

    Therapeutic data will be collected to describe the studied population (antibiotic therapy, duration of treatment, search for an eradication a posteriori...)

Secondary outcomes

  1. Comparison of antibiotic therapy duration to national recommendations issued by the High Committee of Public Health

    Time frame: 3 months

    Duration of antibiotic therapy implemented by clinicians will be compared to national recommendations

  2. Comparison of immunization status monitoring to national recommendations issued by the High Committee of Public Health

    Time frame: 3 months

    Monitoring of immunization status or not will be collected

  3. Comparison of patient post infection vaccination status to national recommendations issued by the High Committee of Public Health

    Time frame: 3 months

    Post-infection vaccination or not will be collected

  4. Comparison of patient microbiological follow-up to national recommendations issued by the High Committee of Public Health

    Time frame: 3 months

    Microbiological follow-up with eradication research or not will be collected.

  5. Comparison of post-infection serological sampling to national recommendations issued by the High Committee of Public Health

    Time frame: 3 months

    Whether a post-infection serological sampling was performed or not will be collected.

  6. Comparison of patient isolation procedures to national recommendations issued by the High Committee of Public Health

    Time frame: 3 months

    Patient isolation or not will be collected.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Collaborators

  • Centre d'Epidémiologie et de Santé Publique des Armées

Registry information

Official study title

Cutaneous Diphtheria in France : an Observational, Retrospective Study of Epidemiological, Clinical, Microbiological and Therapeutic Characteristics

Acronym: OEDIPE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2023
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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