European Co-ordinator-Contact person: George Petrikkos, M.D., Ph.D.

National Co-ordinator: France: Bertrand Dupont

Background

Zygomycoses are rare infections and they have a high fatality rate. They are increasingly being recognized in immunocompromised patients, especially during the recent years. This increasing trend is coincident with more awareness of the disease as well as with the wide use of voriconazole for prophylaxis and empirical therapy in severely immunocompromised patients. The rhinocerebral, pulmonary and disseminated forms are usually seen in patients with underlying hematological malignancies, such as leukemia or lymphoma, in patients receiving immunosuppressive therapy or corticosteroids and in patients with diabetes. Skin and soft tissue infections are often the result of trauma or burns. Even with early diagnosis and aggressive surgical and medical therapy, the mortality rate is high. For this reason, a high degree of suspicion is needed, in order to initiate treatment promptly.

Most publications from Europe are sporadic case reports. There have been some reviews, all of them during long periods of time (ten to twenty years). A more systematic reporting of mucormycosis cases that occur in Europe, would offer the opportunity to better analyze the epidemiology of the disease, improve our diagnostic ability and maybe find more effective ways for treatment and prevention.

Aim

The aim of this study is to collect, record and make an epidemiological analysis of cases of zygomycosis that occur in Europe. By defining the problem, we may be able to plan strategies for improved diagnostic and therapeutic interventions and outcome of these infections.

Material and Methods

Data will be collected from European countries that will collaborate in this study. Every effort will be made for as many as possible countries collaborate in the study. In each country, a primary investigator will be responsible for distributing information and gathering data from all the centers participating. The experience of previous epidemiological studies of ECMM will be used to assign national responsible investigators. Cases of zygomycosis that will occur during a 12-month period (study life) or during the previous 12 months are eligible (if there are sufficient clinical and radiological and/or histological data kept and an isolate kept). The patients may be of any age or immune status. There is no limitation of underlying diseases.

The method of detection of zygomycoses cases will be individualized, depending on the center and the country. There are two ways of approach: One is through the Microbiology and Pathology Laboratories of Hospitals and the other is through the Infectious Diseases, Hematology, Internal Medicine and Surgical Departments. A combined approach is probably the most effective. Cases will be defined as probable or definite. Probable cases may be diagnosed by compatible clinical and/or radiological findings as well as histological findings, whereas definite cases will be diagnosed by compatible clinical and/or radiological and/or histological findings AND isolation of a zygomycete.

The epidemiological characteristics of each case will be recorded in a provided forms. A detailed questionnaire will be used for either hand-written (by post) or electronic transmission of data as Word documents attached to e-mails. CT scans, MRI and other images may be digitalized and sent electronically to the co-ordinating site. A central web-based database will be constructed and the data sent as responses to the questionnaires or as images will be analyzed. Every three months the primary investigator (collaborator) in each country will collect these forms and forward them to the Research Laboratory of Infectious Diseases of the University of Athens, in Greece. An effort will be made to make a web-site so that all investigators will be able to submit their data on-line. This is very important and will help the project.

All isolated strains will be kept for submission to an appointed laboratory in each country. In addition, serum samples from each patient will be kept in store at the appointed laboratory in each country for possible future serological or molecular studies.

All the data will be sent to the Research Laboratory of Infectious Diseases of the University of Athens, where they will be analyzed and the results will be available to all participating investigators. The isolates will be re-identified in the Mycology Reference Laboratory, Microbiology Department University of Athens.

In the event that any publications originate from this study, the investigators’ names that will be cited as authors will be those who will have attributed the largest number of cases to the study. The exact number of authors remains to be decided upon, but it will be probably less than seven. The "ECMM Zygomycosis Working Group" will be mentioned at the end of the authors. All the other authors will be acknowledged as participants of the ECMM Zygomycosis Working Group in the appendix.