Characterizing Diversity and Antifungal Resistance in Immunocompromised ICU Patients With Respiratory Tract Infections

NCT06387667 | Not Yet Recruiting

• 1 other identifier: FIRTI
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immunocompromised ICU Patients With Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Number of fungal species causing pneumonia in immunocompromised ICU patients

  baseline

Secondary Outcomes (2)

• 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

Study Arms (1)

Immunocompromised ICU patients

EXPERIMENTAL

Immunocompromised ICU Patients with Respiratory tract infections

Diagnostic Test: Complete blood count; Diagnostic Test: C-reactive protein, urea, creatinine, Random blood glucose (RBG), aspartate aminotransferase (AST), alanine aminotransferase (ALT); Radiation: CT chest; Diagnostic Test: Microscopic examination; Diagnostic Test: culture and sensitivity

Interventions

Complete blood count DIAGNOSTIC_TEST

blood sample

Immunocompromised ICU patients

C-reactive protein, urea, creatinine, Random blood glucose (RBG), aspartate aminotransferase (AST), alanine aminotransferase (ALT) DIAGNOSTIC_TEST

serum sample

Immunocompromised ICU patients

CT chest RADIATION

Computed tomography of the chest

Immunocompromised ICU patients

Microscopic examination DIAGNOSTIC_TEST

sputum and bronchoalveolar lavage (BAL)

Immunocompromised ICU patients

culture and sensitivity DIAGNOSTIC_TEST

for bacterial and fungal

Immunocompromised ICU patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• New Valley University: lead

Related Publications (5)

• Sprute R, Nacov JA, Neofytos D, Oliverio M, Prattes J, Reinhold I, Cornely OA, Stemler J. Antifungal prophylaxis and pre-emptive therapy: When and how? Mol Aspects Med. 2023 Aug;92:101190. doi: 10.1016/j.mam.2023.101190. Epub 2023 May 17.

  PMID: 37207579 BACKGROUND

• Kett DH, Azoulay E, Echeverria PM, Vincent JL; Extended Prevalence of Infection in ICU Study (EPIC II) Group of Investigators. Candida bloodstream infections in intensive care units: analysis of the extended prevalence of infection in intensive care unit study. Crit Care Med. 2011 Apr;39(4):665-70. doi: 10.1097/CCM.0b013e318206c1ca.

  PMID: 21169817 BACKGROUND

• Bassetti M, Garnacho-Montero J, Calandra T, Kullberg B, Dimopoulos G, Azoulay E, Chakrabarti A, Kett D, Leon C, Ostrosky-Zeichner L, Sanguinetti M, Timsit JF, Richardson MD, Shorr A, Cornely OA. Intensive care medicine research agenda on invasive fungal infection in critically ill patients. Intensive Care Med. 2017 Sep;43(9):1225-1238. doi: 10.1007/s00134-017-4731-2. Epub 2017 Mar 2.

  PMID: 28255613 BACKGROUND

• Meersseman W, Lagrou K, Maertens J, Van Wijngaerden E. Invasive aspergillosis in the intensive care unit. Clin Infect Dis. 2007 Jul 15;45(2):205-16. doi: 10.1086/518852. Epub 2007 Jun 13.

  PMID: 17578780 BACKGROUND

• Hage CA, Carmona EM, Evans SE, Limper AH, Ruminjo J, Thomson CC. Summary for Clinicians: Microbiological Laboratory Testing in the Diagnosis of Fungal Infections in Pulmonary and Critical Care Practice. Ann Am Thorac Soc. 2019 Dec;16(12):1473-1477. doi: 10.1513/AnnalsATS.201908-582CME. No abstract available.

  PMID: 31526275 BACKGROUND

MeSH Terms

Interventions

Blood Cell Count; Microscopy; Sensitivity and Specificity

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Diagnostic Imaging; Epidemiologic Research Design; Epidemiologic Methods; Statistics as Topic; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Asmaa N Hussein, MD

CONTACT

+2 01065161752; asmaanady_1010@med.nvu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Internal Medicine

Model Details: Immunocompromised ICU Patients with Respiratory tract infections

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 29, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share