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Clinical Trials/NCT06387667
NCT06387667RecruitingNot Applicable

Unveiling the Fungal Frontier: Characterizing Diversity and Antifungal Resistance in Immunocompromised ICU Patients With Respiratory Tract Infections

New Valley University1 site in 1 country250 target enrollmentStarted: December 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
250
Locations
1
Primary Endpoint
Number of fungal species causing pneumonia in immunocompromised ICU patients

Study Overview

Brief Summary

Immunocompromised individuals face a heightened risk of life-threatening fungal infections, which arise from a multitude of environmental and commensal fungi. Surveillance data from ICUs worldwide identifies Candida spp. as the dominant foe, responsible for 80% of such infections, earning it the dubious distinction of being the third most prevalent pathogen. While C. albicans holds the dubious crown as the most common Candida offender, recent years have witnessed a concerning trend toward non-Albicans candida, raising concerns about potential antifungal resistance.

Detailed Description

For critically ill patients in the ICU, the threat of invasive fungal infections is a hidden danger, particularly in the presence of any of the following opportunistic factors:

(A) Pre-existing lung disease: Idiopathic pulmonary fibrosis (IPF) , Chronic obstructive pulmonary disease (COPD), or Sarcoidosis.

(B) Patient comorbidities:

  1. Immunosuppression: Neutropenia, Corticosteroid therapy, Immunosuppressive medication for inflammatory or autoimmune diseases; T-cell suppressants: Antithymocyte globulin (ATG), Calcineurin inhibitors (e.g., tacrolimus, cyclosporine) or B-cell suppressants: Rituximab, Severe sepsis (immune paralysis): Inherited severe immunodeficiency: Chronic granulomatous disease (CGD), Wiskott-Aldrich syndrome (WAS), and Common variable immunodeficiency (CVID) or Acquired immunodeficiency due to HIV/AIDS.
  2. Underlying medical conditions: Liver failure, Diabetes mellitus, or cardiovascular disease.
  3. Viral Pneumonia: Influenza-associated pulmonary aspergillosis (IAPA) and Coronavirus disease 2019 (COVID-19)
  4. Hematological and solid malignancies.
  5. Hematopoietic stem cell transplantation (HSCT).
  6. Prior fungal exposure: Aspergillus colonization before or during ICU admission .

(C) Environmental factors: Construction work, Geo-climatic factors, Tobacco or cannabis use, Air, food, or spice contamination, Gardening activity or occupation.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All adult patients (aged >18 years old) admitted to the Assiut University Hospital's intensive care units with pneumonia and hospitalized patients who developed hospital-acquired or ventilator-associated pneumonia who don't respond to antibiotics for 48 hours or with a CT finding suspected for fungal pneumonia.
  • Patients included must have at least one of the following conditions as a contributor to immunocompromise:
  • Pre-existing lung disease: IPF, COPD, or sarcoidosis.
  • Immunosuppression: Neutropenia, on corticosteroids, or immunosuppressive drugs, inherited or acquired immunodeficiency.
  • Underlying comorbidities: (Diabetes Mellitus,Chronic kidney disease, Liver cirrhosis)
  • Malignancy (Hematological or solid)

Exclusion Criteria

  • Patients refused to contribute to the study.
  • Unsatisfactory sample.

Arms & Interventions

Immunocompromised ICU patients

Experimental

Immunocompromised ICU Patients with Respiratory tract infections

Intervention: Complete blood count (Diagnostic Test)

Immunocompromised ICU patients

Experimental

Immunocompromised ICU Patients with Respiratory tract infections

Intervention: C-reactive protein, urea, creatinine, Random blood glucose (RBG), aspartate aminotransferase (AST), alanine aminotransferase (ALT) (Diagnostic Test)

Immunocompromised ICU patients

Experimental

Immunocompromised ICU Patients with Respiratory tract infections

Intervention: CT chest (Radiation)

Immunocompromised ICU patients

Experimental

Immunocompromised ICU Patients with Respiratory tract infections

Intervention: Microscopic examination (Diagnostic Test)

Immunocompromised ICU patients

Experimental

Immunocompromised ICU Patients with Respiratory tract infections

Intervention: culture and sensitivity (Diagnostic Test)

Outcomes

Primary Outcomes

Number of fungal species causing pneumonia in immunocompromised ICU patients

Time Frame: baseline

Secondary Outcomes

  • Determine the antifungal susceptibility profiles of the identified fungal isolates.(baseline)
  • Number of associated specific patient factors with the type or antifungal resistance of fungal infections(baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Asmaa Nady Hussein

Lecturer of Internal Medicine

New Valley University

Study Sites (1)

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