NCT07440485

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
193

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

February 23, 2026

Last Update Submit

February 23, 2026

Conditions

Aspergillus Infection

Outcome Measures

Primary Outcomes (1)

  • number of new onset of invasive aspergillosis

    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 Outcomes (1)

  • correlation between the levels of Aspergillus in the air and the number of subjects with a positive swab at discharge

    up to 2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients admitted to the Hematology ward

You may qualify if:

  • ≥ 18 years old
  • Signature of informed consent
  • Admission to San Matteo's Hematology ward

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Aspergillosis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Central Study Contacts

Alba Muzzi

CONTACT

0382/502268a.muzzi@smatteo.pv.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2026

First Posted

February 27, 2026

Study Start

February 14, 2024

Primary Completion

March 14, 2026

Study Completion

March 14, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

IT(1)