Sautour PHRC IR 2008

Mycosis Clinical Trial

— SautourPHRCI08  

Official title:

Fungal Contamination of a Hospital Water System With Fusarium App.: Prospective Environmental and Medical Surveillance During a Construction Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859831
• Other study ID #: Sautour PHRC IR 2008
• Status: Completed
• Phase: N/A
• First received: August 4, 2016
• Last updated: August 8, 2016

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

Fusarium are microscopic filamentous fungi that live as saprobiontics in outside environments. They are found in the soil, the air, in water and on numerous plants. The frequency of fusariosis is currently increasing and Fusarium-related mycoses are the 3rd most frequent invasive mycoses. Most cases have been reported in the United States, in France, in Italy and in Brazil. A few epidemiological studies have shown the role of water in the appearance of mycoses in highly immunodepressed patients. Few studies have focused on the role of water in the transmission of mycoses in hospitals. The aim of this prospective study is to describe, in time and pace, the contamination by Fusarium sp. in the water of two different hospitals (Dijon, Nancy), by taking into account factors such as seasons and major works (reconstruction of a hospital). In each hospital, one reconstruction site will be compared with a site not under reconstruction (control).

Water samples will be taken from the rooms of hospitalized patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 551
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

all patients with new-onset fusariosis in the Adult Haematology, Internal Medicinie, Digestive Surgery and Rheumatology Departments

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mycoses
• Mycosis

Intervention

Other:
• water samples

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Fusarium sp		every week throughout the study, thus over 3 years	No