- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07440485
Aspergillus Infection in Patients Admitted to Hematology Ward
A Prospective Study on the Incidence of Invasive Aspergillus Infections in Hematology Patients: the Utility of Nasal Swab Screening and Environmental Sampling (AspHem)
Aspergillus is a filamentous mould ubiquitous in the environment and the concentration of its spores in the air varies according to weather conditions and seasons. In this regard, efforts are often made to limit its diffusion in wards where fragile patients are housed (e.g., ICU, Haematology, Oncology, etc.). Indeed, in these patients, Aspergillus infections can present as pulmonary aspergillosis, invasive rhinosinusitis or angio-invasive aspergillosis with significantly high rates of morbidity and mortality, while it rarely causes disease in healthy immunocompetent subjects.
Previous studies have established the correlation between nasal carriage of microorganisms and the development of an invasive infectious disease; however, those studies mainly focused on Staphylococci and Candida species.
The main target of this study is to investigate the spread of Aspergillus within a hospital ward and analyse the correlation between nosocomial infection and symptom severity in a cohort of frail population.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alba Muzzi
- Phone Number: 0382/502268
- Email: a.muzzi@smatteo.pv.it
Study Locations
-
-
Pavia
-
Pavia, Pavia, Italy, 27100
- Recruiting
- Fondazione IRCCS Policlinico San Matteo di Pavia
-
Contact:
- Alba Muzzi
- Phone Number: 0382/502268
- Email: a.muzzi@smatteo.pv.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥ 18 years old
- Signature of informed consent
- Admission to San Matteo's Hematology ward
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of new onset of invasive aspergillosis
Time Frame: up to 2 years
|
number of new onset of invasive aspergillosis in patients who entered the ward with a negative swab at admission over person-time.
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
correlation between the levels of Aspergillus in the air and the number of subjects with a positive swab at discharge
Time Frame: up to 2 years
|
up to 2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AspHem
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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