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

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: Completed
• Conditions: Corynebacterium Diphtheriae Infection
• Intervention / Treatment: Other: Characteristics description

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

• Study Contact: Name: Asmaa JOBIC, PhD; Phone Number: +33 04 83 77 20 61; Email: asmaa.jobic@ch-toulon.fr
• Study Contact Backup: Name: Laure CHENE; Phone Number: +33 04 83 77 20 61; Email: Laure.chene4@gmail.com

Study Locations

• France
  • Paris, France, 75010
    • Hôpital 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 - Hôpital 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 Regional D'Orleans
  • 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-Lo
  • 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
      • Contact: Jean-Jacques MORAND, Pr; Phone Number: +33 04 83 16 25 71; Email: dermatologie@hia-sainte-anne.ssa.msante.fr
  • 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 Departemental de Vendee

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Patients epidemiological data description	Epidemiological data will be collected to describe the studied population (age, sex, place of birth, vaccination status...)	3 months
Patients clinical data description	Clinical data will be collected to describe the studied population (history, description of lesions, disease evolution, complications...)	3 months
Patients microbiological data description	Microbiological data will be collected to describe the studied population (species identification, toxigenicity, presence of a co-infection...)	3 months
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...)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
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	3 months
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	3 months
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.	3 months
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.	3 months
Comparison of patient isolation procedures to national recommendations issued by the High Committee of Public Health	Patient isolation or not will be collected.	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Collaborators: Centre d'Epidémiologie et de Santé Publique des Armées
• Investigators: Study Director: Fabien DUTASTA, MD, SSA

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Related Info
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Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cutaneous; Diphteria
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Corynebacterium Infections; Diphtheria
• Other Study ID 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