Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06387667
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-01
Brief Title:
Characterizing Diversity and Antifungal Resistance in Immunocompromised ICU Patients With Respiratory Tract Infections
Sponsor:
New Valley University
Organization:
New Valley University
Study Overview
Official Title:
Unveiling the Fungal Frontier Characterizing Diversity and Antifungal Resistance in Immunocompromised ICU Patients With Respiratory Tract Infections
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 HIVAIDS
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
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
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 eg 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 HIVAIDS
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None