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CompletedNCT05798247OEDIPEUpdated Jul 10, 2025

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

An observational study in Corynebacterium Diphtheriae Infection, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Completed at 42 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-10.

Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
63
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Corynebacterium Diphtheriae Infection

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Keywords

  • Cutaneous
  • Diphteria
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

- Patient opposition

04

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
63 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherCharacteristics description

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

05

What researchers measure

Primary outcomes

  1. Patients epidemiological data description

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

    Time frame: 3 months

  2. Patients clinical data description

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

    Time frame: 3 months

  3. Patients microbiological data description

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

    Time frame: 3 months

  4. Patients therapeutic data description

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

    Time frame: 3 months

Secondary outcomes

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

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

    Time frame: 3 months

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

    Monitoring of immunization status or not will be collected

    Time frame: 3 months

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

    Post-infection vaccination or not will be collected

    Time frame: 3 months

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

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

    Time frame: 3 months

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

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

    Time frame: 3 months

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

    Patient isolation or not will be collected.

    Time frame: 3 months

06

Study locations

42 sites
  • Institut Hospitalo-Universitaire de Marseille
    Marseille, Bouches-du-Rhône 13005, France
  • CHU de Dijon
    Dijon, Bourgogne-Franche-Comté 21079, France
  • CHU de Caen
    Caen, Calvados 14000, France
  • Centre Hospitalier de Brive
    Brive-la-Gaillarde, Corrèze 19100, France
  • Centre Hospitalier de Guingamp
    Pabu, Côtes d'Armor 22205, France
  • Centre Hospitalier Sud Francilien
    Corbeil-Essonnes, Essonne 91100, France
  • CHU Bordeaux
    Bordeaux, Gironde 33000, France
  • Hôpital Louis Pasteur (HCC)
    Colmar, Haut-Rhin 68024, France
  • Centre Hospitalier Alpes-Leman CHAL
    Contamine-sur-Arve, Haute-Savoie 74130, France
  • Centre Hospitalier de Briançon
    Briançon, Hautes-Alpes 05100, France
  • Centre Hospitalier de Lourdes
    Lourdes, Hautes-Pyrénées 65107, France
  • Hôpital Ambroise Paré (AP-HP)
    Boulogne-Billancourt, Hauts-de-Seine 92100, France
  • Hôpital Américain de Paris
    Neuilly-sur-Seine, Hauts-de-Seine 92200, France
  • CHU de Montpellier
    Montpellier, Hérault 34295, France
  • CHRU de Tours
    Chambray-lès-Tours, Indre-et-Loire 37170, France
  • Groupement Hospitalier Nord Dauphiné
    Bourgoin, Isère 38300, France
  • CHU de Nantes
    Nantes, Loire-Atlantique 44000, France
  • Centre Hospitalier Régional d'Orléans
    Orléans, Loiret 45067, France
  • Centre Hospitalier de Cahors
    Cahors, Lot 46005, France
  • Centre Hospitalier Cholet
    Cholet, Maine-et-Loire 49300, France
  • Centre Hospitalier de Saint-Lo
    Saint-Lô, Manche 50000, France
  • CHU de Lille
    Lille, Nord 59037, France
  • Centre Hospitalier de Valenciennes
    Valenciennes, Nord 59300, France
  • CHU de Saint-Etienne
    Saint-Priest-en-Jarez, Pays de la Loire Region 42270, France
  • Centre d'endocrinologie
    Cabestany, Pyrénées Orientales 66300, France
  • Hôpital Edouard Herriot (HCL)
    Lyon, Rhône 69003, France
  • Hôpital Croix rousse (HCL)
    Lyon, Rhône 69004, France
  • Centre Hospitalier William Morey
    Chalon-sur-Saône, Saône-et-Loire 71321, France
  • Centre Hospitalier de Mâcon
    Mâcon, Saône-et-Loire 71000, France
  • Hôpital Avicenne Bobigny (AP-HP)
    Bobigny, Seine-Saint-Denis 93000, France
  • CHU d'Amiens
    Amiens, Somme 80054, France
  • Hôpital Nord Franche-Comté
    Trévenans, Territoire De Belfort 90400, France
  • Hôpital Henri Mondor (AP-HP)
    Créteil, Val-de-Marne 94000, France
  • HIA Sainte Anne
    Toulon, VAR 83000, France
  • Centre Hospitalier d'Avignon
    Avignon, Vaucluse 84000, France
  • Centre Hospitalier Départemental de Vendée
    La Roche-sur-Yon, Vendée 85000, France
  • Hôpital Saint Joseph
    Paris, 13008, France
  • Hôpital Saint Louis
    Paris, 75010, France
  • Hôpital Saint Antoine
    Paris, 75012, France
  • Hôpital La Pitié Salpêtrière
    Paris, 75013, France
  • Groupement Hospitalier Diaconesses Croix Saint Simon
    Paris, 75020, France
  • CHU de Toulouse - Hôpital La Grave
    Toulouse, 31300, France
07

References and documents

Publications

  • Bernard KA, Pacheco AL, Burdz T, Wiebe D. Increase in detection of Corynebacterium diphtheriae in Canada: 2006-2019. Can Commun Dis Rep. 2019 Nov 7;45(11):296-301. doi: 10.14745/ccdr.v45i11a04. eCollection 2019 Nov 7. PubMed 31755876 ↗
  • Martini H, Soetens O, Litt D, Fry NK, Detemmerman L, Wybo I, Desombere I, Efstratiou A, Pierard D. Diphtheria in Belgium: 2010-2017. J Med Microbiol. 2019 Oct;68(10):1517-1525. doi: 10.1099/jmm.0.001039. PubMed 31418673 ↗
  • Jaton L, Kritikos A, Bodenmann P, Greub G, Merz L. [European migrant crisis and reemergence of infections in Switzerland]. Rev Med Suisse. 2016 Apr 13;12(514):749-53. French. PubMed 27263151 ↗
  • Morgado-Carrasco D, Riquelme-Mc Loughlin C, Fusta-Novell X, Fernandez-Pittol MJ, Bosch J, Mascaro JM Jr. Cutaneous Diphtheria Mimicking Pyoderma Gangrenosum. JAMA Dermatol. 2018 Feb 1;154(2):227-228. doi: 10.1001/jamadermatol.2017.4786. No abstract available. PubMed 29282460 ↗
  • Pandit N, Yeshwanth M. Cutaneous diphtheria in a child. Int J Dermatol. 1999 Apr;38(4):298-9. doi: 10.1046/j.1365-4362.1999.00658.x. No abstract available. PubMed 10321948 ↗
  • Wagner KS, White JM, Lucenko I, Mercer D, Crowcroft NS, Neal S, Efstratiou A; Diphtheria Surveillance Network. Diphtheria in the postepidemic period, Europe, 2000-2009. Emerg Infect Dis. 2012 Feb;18(2):217-25. doi: 10.3201/eid1802.110987. PubMed 22304732 ↗
  • Gower CM, Scobie A, Fry NK, Litt DJ, Cameron JC, Chand MA, Brown CS, Collins S, White JM, Ramsay ME, Amirthalingam G. The changing epidemiology of diphtheria in the United Kingdom, 2009 to 2017. Euro Surveill. 2020 Mar;25(11):1900462. doi: 10.2807/1560-7917.ES.2020.25.11.1900462. PubMed 32209165 ↗
  • Koopman JS, Campbell J. The role of cutaneous diphtheria infections in a diphtheria epidemic. J Infect Dis. 1975 Mar;131(3):239-44. doi: 10.1093/infdis/131.3.239. PubMed 805182 ↗
  • de Benoist AC, White JM, Efstratiou A, Kelly C, Mann G, Nazareth B, Irish CJ, Kumar D, Crowcroft NS. Imported cutaneous diphtheria, United Kingdom. Emerg Infect Dis. 2004 Mar;10(3):511-3. doi: 10.3201/eid1003.030524. PubMed 15109425 ↗
  • Chene L, Morand JJ, Badell E, Toubiana J, Janvier F, Marthinet H, Suppini JP, Valois A, Texier G, Brisse S, Dutasta F OEDIPE Study Group. Cutaneous diphtheria from 2018 to 2022: an observational, retrospective study of epidemiological, microbiological, clinical, and therapeutic characteristics in metropolitan France. Emerg Microbes Infect. 2024 Dec;13(1):2408324. doi: 10.1080/22221751.2024.2408324. Epub 2024 Sep 30. PubMed 39324172 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT05798247
Lead sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators
Centre d'Epidémiologie et de Santé Publique des Armées
Responsible party
Sponsor
First posted
Apr 4, 2023
Start date
Apr 3, 2023
Primary completion
Aug 10, 2023
Completion
Aug 10, 2023
Last update
Jul 10, 2025

Study contacts

Fabien DUTASTA, MD
study director · SSA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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