Clinical trial NCT05798247: Cutaneous Diphtheria in France : Observational, Retrospective Study of Patient Characteristics
Official title: Cutaneous Diphtheria in France : an Observational, Retrospective Study of Epidemiological, Clinical, Microbiological and Therapeutic Characteristics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corynebacterium Diphtheriae Infection
Keywords: Cutaneous
Diphteria
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
Collaborators: name: Centre d'Epidémiologie et de Santé Publique des Armées
First posted: 2023-04-04
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Patients epidemiological data description
timeFrame: 3 months
measure: Patients clinical data description
timeFrame: 3 months
measure: Patients microbiological data description
timeFrame: 3 months
measure: Patients therapeutic data description
timeFrame: 3 months
Secondary outcomes:
measure: Comparison of antibiotic therapy duration to national recommendations issued by the High Committee of Public Health
timeFrame: 3 months
measure: Comparison of immunization status monitoring to national recommendations issued by the High Committee of Public Health
timeFrame: 3 months
measure: Comparison of patient post infection vaccination status to national recommendations issued by the High Committee of Public Health
timeFrame: 3 months
measure: Comparison of patient microbiological follow-up to national recommendations issued by the High Committee of Public Health
timeFrame: 3 months
measure: Comparison of post-infection serological sampling to national recommendations issued by the High Committee of Public Health
timeFrame: 3 months
measure: Comparison of patient isolation procedures to national recommendations issued by the High Committee of Public Health
timeFrame: 3 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Hospitalo-Universitaire de Marseille
state: Bouches-du-Rhône
city: Dijon
country: France
facility: CHU de Dijon
state: Bourgogne
city: Caen
country: France
facility: CHU de Caen
state: Calvados
city: Brive-la-Gaillarde
country: France
facility: Centre Hospitalier de Brive
state: Corrèze
city: Pabu
country: France
facility: Centre Hospitalier de Guingamp
state: Côtes d'Armor
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
state: Essonne
city: Bordeaux
country: France
facility: CHU Bordeaux
state: Gironde
city: Colmar
country: France
facility: Hôpital Louis Pasteur (HCC)
state: Haut-Rhin
city: Contamine-sur-Arve
country: France
facility: Centre Hospitalier Alpes-Leman CHAL
state: Haute-Savoie
city: Briançon
country: France
facility: Centre Hospitalier de Briançon
state: Hautes-Alpes
city: Lourdes
country: France
facility: Centre Hospitalier de Lourdes
state: Hautes-Pyrénées
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré (AP-HP)
state: Hauts-de-Seine
city: Neuilly-sur-Seine
country: France
facility: Hôpital Américain de Paris
state: Hauts-de-Seine
city: Montpellier
country: France
facility: CHU de Montpellier
state: Hérault
city: Chambray-lès-Tours
country: France
facility: CHRU de Tours
state: Indre-et-Loire
city: Bourgoin-Jallieu
country: France
facility: Groupement Hospitalier Nord Dauphiné
state: Isère
city: Nantes
country: France
facility: CHU de Nantes
state: Loire-Atlantique
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans
state: Loiret
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne
state: Loire
city: Cahors
country: France
facility: Centre Hospitalier de Cahors
state: Lot
city: Cholet
country: France
facility: Centre Hospitalier Cholet
state: Maine-et-Loire
city: Saint-Lô
country: France
facility: Centre Hospitalier de Saint-Lo
state: Manche
city: Lille
country: France
facility: CHU de Lille
state: Nord
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes
state: Nord
city: Cabestany
country: France
facility: Centre d'endocrinologie
state: Pyrénées Orientales
city: Lyon
country: France
facility: Hôpital Edouard Herriot (HCL)
state: Rhône
city: Lyon
country: France
facility: Hôpital Croix rousse (HCL)
state: Rhône
city: Chalon-sur-Saône
country: France
facility: Centre Hospitalier William Morey
state: Saône-et-Loire
city: Mâcon
country: France
facility: Centre Hospitalier de Mâcon
state: Saône-et-Loire
city: Bobigny
country: France
facility: Hôpital Avicenne Bobigny (AP-HP)
state: Seine-Saint-Denis
city: Amiens
country: France
facility: CHU d'Amiens
state: Somme
city: Trévenans
country: France
facility: Hôpital Nord Franche-Comté
state: Territoire De Belfort
city: Créteil
country: France
facility: Hôpital Henri Mondor (AP-HP)
state: Val-de-Marne
city: Toulon
country: France
facility: HIA Sainte Anne
state: VAR
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon
state: Vaucluse
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Départemental de Vendée
state: Vendée
city: Paris
country: France
facility: Hôpital Saint Joseph
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Paris
country: France
facility: Hôpital La Pitié Salpêtrière
city: Paris
country: France
facility: Groupement Hospitalier Diaconesses Croix Saint Simon
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital La Grave
Study officials:
affiliation: SSA
name: Fabien DUTASTA, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.