Immunocompromised ICU Patients With Respiratory Tract InfectionsNCT06387667
Characterizing Diversity and Antifungal Resistance in Immunocompromised ICU Patients With Respiratory Tract Infections
A study testing Complete blood count, C-reactive protein, urea, creatinine, Random blood glucose (RBG), aspartate aminotransferase (AST), alanine aminotransferase (ALT) and CT chest in people with Immunocompromised ICU Patients With Respiratory Tract Infections, run by New Valley University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunocompromised ICU Patients With Respiratory Tract Infections
- What is being tested?
- Complete blood count, C-reactive protein, urea, creatinine, Random blood glucose (RBG), aspartate aminotransferase (AST), alanine aminotransferase (ALT) and CT chest
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients refused to contribute to the study.
- Unsatisfactory sample.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71511
Asmaa N Hussein, MD, 01065161752, asmaanady_1010@med.nvu.edu.eg
About this study
Official title: Unveiling the Fungal Frontier: Characterizing Diversity and Antifungal Resistance in Immunocompromised ICU Patients With Respiratory Tract Infections
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.
Read the 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:
- 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.
- Underlying medical conditions: Liver failure, Diabetes mellitus, or cardiovascular disease.
- Viral Pneumonia: Influenza-associated pulmonary aspergillosis (IAPA) and Coronavirus disease 2019 (COVID-19)
- Hematological and solid malignancies.
- Hematopoietic stem cell transplantation (HSCT).
- 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.
For diagnosing an invasive fungal infection (IFI), symptoms are unspecific; fever, cough, or chest pain and often missed in patients on corticosteroids, the host criteria including the presence of high-risk factors like neutropenia, malignancies, or immunosuppression, the clinical criteria; specific imaging findings on chest X-ray, high-resolution computed tomography (HRCT) or bronchoscopy indicating pulmonary involvement then finally mycological Criteria: Positive fungal detection in samples (culture, polymerase chain reaction 'PCR', GM).
In Non-Hematological Patients, diagnosis often delayed due to atypical symptoms and imaging, potentially leading to airway invasion vs. angioinvasion, differing clinical presentation and tests. Also, Lower GM yield compared to hematological patients. Crucially, this delayed diagnosis contributes to the higher mortality in non-hematological patients. This underscores the urgent need to establish improved diagnostic capabilities for invasive pulmonary aspergillosis using mycological tests in non-hematological individuals.
By closely monitoring the prevalence and drug susceptibility patterns of fungal pathogens, leads to acquiring crucial insights into their dynamics and refine the therapeutic approaches accordingly. This data empowers clinicians to make informed decisions regarding antifungal therapy, minimizing unnecessary drug exposure and preserving the effectiveness of the antifungal weapons.
Based on the need for more specific studies on diagnosis, prophylaxis, and therapy of critically ill, non-neutropenic, patients, and the significant threats of fungal infections to immunocompromised patients, particularly in ICU settings, understanding the diversity and antifungal resistance of these infections is crucial for optimizing treatment strategies and improving patient outcomes. This study will provide valuable insights into the epidemiology and antifungal resistance of fungal infections in immunocompromised ICU patients, informing the development of more effective prevention and treatment strategies.
- Being tested
- Complete blood count, C-reactive protein, urea, creatinine, Random blood glucose (RBG), aspartate aminotransferase (AST), alanine aminotransferase (ALT), CT chest, Microscopic examination, culture and sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete blood countDiagnostic test
blood sample
C-reactive protein, urea, creatinine, Random blood glucose (RBG), aspartate aminotransferase (AST), alanine aminotransferase (ALT)Diagnostic test
serum sample
CT chestRadiation
Computed tomography of the chest
Microscopic examinationDiagnostic test
sputum and bronchoalveolar lavage (BAL)
culture and sensitivityDiagnostic test
for bacterial and fungal
| Study group | Role | What they receive |
|---|---|---|
| Immunocompromised ICU patients | Experimental | Immunocompromised ICU Patients with Respiratory tract infections Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of fungal species causing pneumonia in immunocompromised ICU patients
Measured: baseline
Secondary outcomes (2)
Determine the antifungal susceptibility profiles of the identified fungal isolates.
Measured: baseline
Number of associated specific patient factors with the type or antifungal resistance of fungal infections
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Immunocompromised ICU Patients With Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Immunocompromised ICU Patients with Respiratory tract infections
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Nady Hussein, New Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387667
- Sponsor's protocol ID
- FIRTI
- Status last verified
- Jul 2026
- First submitted
- 1 Apr 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37207579Kett 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.
PubMed 21169817Bassetti 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.
PubMed 28255613Meersseman 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.
PubMed 17578780Hage 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.
PubMed 31526275
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unveiling the Fungal Frontier: Characterizing Diversity and Antifungal Resistance in Immunocompromised ICU Patients With Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT06387667
- Acronym / sponsor ID
- FIRTI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- New Valley UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Underlying medical conditions: Liver failure, Diabetes mellitus, or cardiovascular disease.
- Viral Pneumonia: Influenza-associated pulmonary aspergillosis (IAPA) and Coronavirus disease 2019 (COVID-19)
- Hematological and solid malignancies.
- Hematopoietic stem cell transplantation (HSCT).
- 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.
For diagnosing an invasive fungal infection (IFI), symptoms are unspecific; fever, cough, or chest pain and often missed in patients on corticosteroids, the host criteria including the presence of high-risk factors like neutropenia, malignancies, or immunosuppression, the clinical criteria; specific imaging findings on chest X-ray, high-resolution computed tomography (HRCT) or bronchoscopy indicating pulmonary involvement then finally mycological Criteria: Positive fungal detection in samples (culture, polymerase chain reaction 'PCR', GM).
In Non-Hematological Patients, diagnosis often delayed due to atypical symptoms and imaging, potentially leading to airway invasion vs. angioinvasion, differing clinical presentation and tests. Also, Lower GM yield compared to hematological patients. Crucially, this delayed diagnosis contributes to the higher mortality in non-hematological patients. This underscores the urgent need to establish improved diagnostic capabilities for invasive pulmonary aspergillosis using mycological tests in non-hematological individuals.
By closely monitoring the prevalence and drug susceptibility patterns of fungal pathogens, leads to acquiring crucial insights into their dynamics and refine the therapeutic approaches accordingly. This data empowers clinicians to make informed decisions regarding antifungal therapy, minimizing unnecessary drug exposure and preserving the effectiveness of the antifungal weapons.
Based on the need for more specific studies on diagnosis, prophylaxis, and therapy of critically ill, non-neutropenic, patients, and the significant threats of fungal infections to immunocompromised patients, particularly in ICU settings, understanding the diversity and antifungal resistance of these infections is crucial for optimizing treatment strategies and improving patient outcomes. This study will provide valuable insights into the epidemiology and antifungal resistance of fungal infections in immunocompromised ICU patients, informing the development of more effective prevention and treatment strategies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Immunocompromised ICU Patients with Respiratory tract infections
| Arm | Type | Receives |
|---|---|---|
| Immunocompromised ICU patients | Experimental | 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 sensitivityImmunocompromised ICU Patients with Respiratory tract infections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- Patients refused to contribute to the study.
- Unsatisfactory sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete blood countblood sample | Diagnostic test | Immunocompromised ICU patients |
| C-reactive protein, urea, creatinine, Random blood glucose (RBG), aspartate aminotransferase (AST), alanine aminotransferase (ALT)serum sample | Diagnostic test | Immunocompromised ICU patients |
| CT chestComputed tomography of the chest | Radiation | Immunocompromised ICU patients |
| Microscopic examinationsputum and bronchoalveolar lavage (BAL) | Diagnostic test | Immunocompromised ICU patients |
| culture and sensitivityfor bacterial and fungal | Diagnostic test | Immunocompromised ICU patients |
Primary outcome
Number of fungal species causing pneumonia in immunocompromised ICU patients
Time frame: baseline
2 secondary outcomes
Determine the antifungal susceptibility profiles of the identified fungal isolates.
Time frame: baseline
Number of associated specific patient factors with the type or antifungal resistance of fungal infections
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 37207579Sprute 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.
- Background: PubMed 21169817Kett 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.
- Background: PubMed 28255613Bassetti 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.
- Background: PubMed 17578780Meersseman 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.
- Background: PubMed 31526275Hage 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete blood count, C-reactive protein, urea, creatinine, Random blood glucose (RBG), aspartate aminotransferase (AST), alanine aminotransferase (ALT) and CT chest in people with Immunocompromised ICU Patients With Respiratory Tract Infections, run by New Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa N Hussein, MD (+2 01065161752, asmaanady_1010@med.nvu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of fungal species causing pneumonia in immunocompromised ICU patients (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06387667, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.