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

July 7, 2025 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75010
        • Hopital saint Louis
      • Paris, France, 75012
        • Hopital Saint Antoine
      • Paris, France, 75013
        • Hôpital La Pitié Salpêtrière
      • Paris, France, 13008
        • Hopital Saint Joseph
      • Paris, France, 75020
        • Groupement Hospitalier Diaconesses Croix Saint Simon
      • Toulouse, France, 31300
        • CHU de Toulouse - Hopital La Grave
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13005
        • Institut Hospitalo-Universitaire de Marseille
    • Bourgogne
      • Dijon, Bourgogne, France, 21079
        • CHU de DIJON
    • Calvados
      • Caen, Calvados, France, 14000
        • CHU de Caen
    • Corrèze
      • Brive-la-Gaillarde, Corrèze, France, 19100
        • Centre Hospitalier de Brive
    • Côtes d'Armor
      • Pabu, Côtes d'Armor, France, 22205
        • Centre Hospitalier de Guingamp
    • Essonne
      • Corbeil-Essonnes, Essonne, France, 91100
        • Centre Hospitalier Sud Francilien
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • CHU Bordeaux
    • Haut-Rhin
      • Colmar, Haut-Rhin, France, 68024
        • Hôpital Louis Pasteur (HCC)
    • Haute-Savoie
      • Contamine-sur-Arve, Haute-Savoie, France, 74130
        • Centre Hospitalier Alpes-Leman CHAL
    • Hautes-Alpes
      • Briançon, Hautes-Alpes, France, 05100
        • Centre Hospitalier de Briançon
    • Hautes-Pyrénées
      • Lourdes, Hautes-Pyrénées, France, 65107
        • Centre Hospitalier de Lourdes
    • Hauts-de-Seine
      • Boulogne-Billancourt, Hauts-de-Seine, France, 92100
        • Hôpital Ambroise Paré (AP-HP)
      • Neuilly-sur-Seine, Hauts-de-Seine, France, 92200
        • Hôpital Américain de Paris
    • Hérault
      • Montpellier, Hérault, France, 34295
        • CHU de Montpellier
    • Indre-et-Loire
      • Chambray-lès-Tours, Indre-et-Loire, France, 37170
        • CHRU de Tours
    • Isère
      • Bourgoin-Jallieu, Isère, France, 38300
        • Groupement Hospitalier Nord Dauphiné
    • Loire
      • Saint-Priest-en-Jarez, Loire, France, 42270
        • Chu de Saint-Etienne
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44000
        • Chu de Nantes
    • Loiret
      • Orléans, Loiret, France, 45067
        • Centre Hospitalier Régional D'orléans
    • Lot
      • Cahors, Lot, France, 46005
        • Centre Hospitalier de Cahors
    • Maine-et-Loire
      • Cholet, Maine-et-Loire, France, 49300
        • Centre Hospitalier Cholet
    • Manche
      • Saint-Lô, Manche, France, 50000
        • Centre Hospitalier de Saint-Lô
    • Nord
      • Lille, Nord, France, 59037
        • CHU de Lille
      • Valenciennes, Nord, France, 59300
        • Centre Hospitalier de Valenciennes
    • Pyrénées Orientales
      • Cabestany, Pyrénées Orientales, France, 66300
        • Centre d'endocrinologie
    • Rhône
      • Lyon, Rhône, France, 69003
        • Hôpital Edouard Herriot (HCL)
      • Lyon, Rhône, France, 69004
        • Hôpital Croix rousse (HCL)
    • Saône-et-Loire
      • Chalon-sur-Saône, Saône-et-Loire, France, 71321
        • Centre Hospitalier William Morey
      • Mâcon, Saône-et-Loire, France, 71000
        • Centre Hospitalier de Mâcon
    • Seine-Saint-Denis
      • Bobigny, Seine-Saint-Denis, France, 93000
        • Hôpital Avicenne Bobigny (AP-HP)
    • Somme
      • Amiens, Somme, France, 80054
        • CHU D'amiens
    • Territoire De Belfort
      • Trévenans, Territoire De Belfort, France, 90400
        • Hôpital Nord Franche-Comté
    • VAR
      • Toulon, VAR, France, 83000
        • HIA Sainte Anne
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94000
        • Hôpital Henri Mondor (AP-HP)
    • Vaucluse
      • Avignon, Vaucluse, France, 84000
        • Centre hospitalier d'Avignon
    • Vendée
      • La Roche-sur-Yon, Vendée, France, 85000
        • Centre Hospitalier Départemental de Vendée

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study population corresponds to all metropolitan French patients suffering from cutaneous diphtheria for which microbiological data were registered between 2018 and 2022 by the National Reference Center for corynebacteria of the diphteriae complex.

Description

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with cutaneous diphteria
The study group consists of all the patients suffering from cutaneous diphtheria in metropolitan France and for which microbiological data were registered by the National Reference Center fo corynebacteria of the diphteriae complex between 2018 and 2022.
Other: Characteristics description
Caregivers who follow the patients of the study group will be contacted to collect these patients clinical and epidemiological characteristics

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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...)
3 months
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 months
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...)
3 months
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...)
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
3 months
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 months
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
3 months
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.
3 months
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.
3 months
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.
3 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre d'Epidémiologie et de Santé Publique des Armées

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Fabien DUTASTA, MD, SSA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-CHITS-013

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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