Clinical Research Details

Descriptive Information
International Experience of Antifungal Voriconazole Containing Regimens Compared to Amphotericin B Based Therapy as an Empiric VS Diagnostic Driven Primary Therapy for Invasive Aspergillosis in High-Risk Patients

Souha Kanj Shararah
sk11@aub.edu.lb

BIO-2017-0321
Completed

Observational  


No
Sponsors
  • Worldwide Institute for Medical Education (WIME)
Coordinators
Saeed El Zein
se82@aub.edu.lb
Extension: 2093
Conditions and Keywords
Invasive Asperillosis
Invasive aspergillosis ,Hematologic malignancy,Critically ill patients,AmphoB,Voriconazole
Study Design
Other: Describe in Detailed Description
Voriconazole Containing Regimens Compared to Amphotericin B Based Therapy as an Empiric vs Diagnostic Driven Primary Therapy for Invasive Aspergillosis in High-Risk Patients
N/A: Not Applicable
Retrospective
N/A: Not Applicable
N/A: Not Applicable
N/A: Not Applicable
N/A: Not Applicable
Eligibility and IRB
Both
Min: 12
Max: 86
Yes
No

The primary objective of this study is to compare the efficacy of early (presumptive vs   diagnostic driven) Primary Therapy of documented Invasive Aspergillosis (IA) in high-risk patients using Voriconazole containing regiment  in comparison with amphotericin B based Therapy. This is a multicenter international study that aims at evaluating the global experience, Far East (Japan), Middle East (Lebanon) and South America (Brazil). 


All patients diagnosed with probable or definite invasive aspergillosis admitted to AUBMC. 




The patient population to be included will consist of high–risk patients with hematologic malignancy, HSCT and ICU critically ill patients with invasive aspergillosis.  

Inclusion criteria:

1-    Age range of patients:  12-86 years of age

2-    Patients with a proven or probable invasive aspergillosis (e.g., patients who have had a CT scan of the chest done with either a documented positive culture for aspergillosis or a documented positive galactomannan test in Bal or blood whereby the appropriate antifungal therapy was started early (Empiric VS diagnostic driven)


1.       Subjects with other fungal infection such as (mucormycosis, fusariosis, etc.)

2.         Subjects with hematologic malignancy/ critically ill /HSCT who did not have a positive culture or biopsy positive for aspergillosis (Possible IA)