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Corynebacterium Diphtheriae InfectionOEDIPENCT05798247

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

An observational study of Corynebacterium Diphtheriae Infection, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 42 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Corynebacterium Diphtheriae Infection
What is being tested?
Characteristics description
How many people
63 participants
Where
42 sitesFrance
Study dates
3 Apr 2023to 10 Aug 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Patient opposition

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

France42 sites

  • CHU d'Amiens

    Amiens, Somme, 80054

  • Centre Hospitalier d'Avignon

    Avignon, Vaucluse, 84000

  • Hôpital Avicenne Bobigny (AP-HP)

    Bobigny, Seine-Saint-Denis, 93000

  • CHU Bordeaux

    Bordeaux, Gironde, 33000

  • Hôpital Ambroise Paré (AP-HP)

    Boulogne-Billancourt, Hauts-de-Seine, 92100

  • Groupement Hospitalier Nord Dauphiné

    Bourgoin, Isère, 38300

  • Centre Hospitalier de Briançon

    Briançon, Hautes-Alpes, 05100

  • Centre Hospitalier de Brive

    Brive-la-Gaillarde, Corrèze, 19100

  • Centre d'endocrinologie

    Cabestany, Pyrénées Orientales, 66300

  • CHU de Caen

    Caen, Calvados, 14000

  • Centre Hospitalier de Cahors

    Cahors, Lot, 46005

  • Centre Hospitalier William Morey

    Chalon-sur-Saône, Saône-et-Loire, 71321

  • CHRU de Tours

    Chambray-lès-Tours, Indre-et-Loire, 37170

  • Centre Hospitalier Cholet

    Cholet, Maine-et-Loire, 49300

  • Hôpital Louis Pasteur (HCC)

    Colmar, Haut-Rhin, 68024

  • Centre Hospitalier Alpes-Leman CHAL

    Contamine-sur-Arve, Haute-Savoie, 74130

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, Essonne, 91100

  • Hôpital Henri Mondor (AP-HP)

    Créteil, Val-de-Marne, 94000

  • CHU de Dijon

    Dijon, Bourgogne-Franche-Comté, 21079

  • Centre Hospitalier Départemental de Vendée

    La Roche-sur-Yon, Vendée, 85000

  • CHU de Lille

    Lille, Nord, 59037

  • Centre Hospitalier de Lourdes

    Lourdes, Hautes-Pyrénées, 65107

  • Hôpital Edouard Herriot (HCL)

    Lyon, Rhône, 69003

  • Hôpital Croix rousse (HCL)

    Lyon, Rhône, 69004

  • Centre Hospitalier de Mâcon

    Mâcon, Saône-et-Loire, 71000

  • Institut Hospitalo-Universitaire de Marseille

    Marseille, Bouches-du-Rhône, 13005

  • CHU de Montpellier

    Montpellier, Hérault, 34295

  • CHU de Nantes

    Nantes, Loire-Atlantique, 44000

  • Hôpital Américain de Paris

    Neuilly-sur-Seine, Hauts-de-Seine, 92200

  • Centre Hospitalier Régional d'Orléans

    Orléans, Loiret, 45067

  • Centre Hospitalier de Guingamp

    Pabu, Côtes d'Armor, 22205

  • Hôpital Saint Joseph

    Paris, 13008

  • Hôpital Saint Louis

    Paris, 75010

  • Hôpital Saint Antoine

    Paris, 75012

  • Hôpital La Pitié Salpêtrière

    Paris, 75013

  • Groupement Hospitalier Diaconesses Croix Saint Simon

    Paris, 75020

  • Centre Hospitalier de Saint-Lo

    Saint-Lô, Manche, 50000

  • CHU de Saint-Etienne

    Saint-Priest-en-Jarez, Pays de la Loire Region, 42270

  • HIA Sainte Anne

    Toulon, VAR, 83000

  • CHU de Toulouse - Hôpital La Grave

    Toulouse, 31300

  • Hôpital Nord Franche-Comté

    Trévenans, Territoire De Belfort, 90400

  • Centre Hospitalier de Valenciennes

    Valenciennes, Nord, 59300

Other trials in France

About this study

Official title: 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.

Being tested
Characteristics description
Keywords
Cutaneous, Diphteria
Medical subject headings
Diphtheria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Characteristics descriptionOther

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

Study groups in NCT05798247
Study groupRoleWhat they receive
Patients with cutaneous diphteriaThe 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.
Receives: Other: Characteristics description

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patients epidemiological data description

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

    Measured: 3 months

  2. Patients clinical data description

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

    Measured: 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...)

    Measured: 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...)

    Measured: 3 months

Secondary outcomes (6)

  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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start3 Apr 2023
  3. Primary completion10 Aug 2023
  4. Study completion10 Aug 2023

Resources

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
Other
Time perspective
Retrospective
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05798247
Sponsor's protocol ID
2022-CHITS-013
Acronym
OEDIPE
Status last verified
Jul 2025
First submitted
21 Mar 2023
Last updated
10 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Corynebacterium Diphtheriae Infection, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 42 sites 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 2 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: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients epidemiological data description (time frame: 3 months). 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?

On the ClinicalTrials.gov record for NCT05798247, which also lists 10 linked publications.

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 10 Jul 2025.

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