Invasive Aspergillosis Clinical Trial
Official title:
A Multicentre Randomised Controlled Trial Comparing the Current Standard Diagnostic Strategy for Invasive Aspergillosis to the New Diagnostic Strategy for Invasive Aspergillosis in High-Risk Haematology Patients in Order to Determine Which Strategy Results in the Lower Rates of Use of Empiric Antifungal Therapy
Aspergillus is a fungus found in soil, on farms and on construction sites. In those whose
immune system is impaired it causes severe infection. The people who are particularly at
high-risk of infection with Aspergillus (which is called Invasive Aspergillosis)are those
with acute leukaemia who are having chemotherapy and those post bone marrow transplantation.
Currently 15% of those at high-risk develop Invasive Aspergillosis and 60-90% of those with
Invasive Aspergillosis die.
The main reason for this high death rate is that our current diagnostic tests are not good
at detecting infection or often only detect the infection at advanced stages when treatment
is ineffective. Because of the limitations of current diagnostic tests the current practice
is to give empiric antifungal therapy (EAFT) early to treat suspected Invasive
Aspergillosis. However studies have demonstrated that this therapy has only resulted in a
minor reduction in the mortality rates and it also causes significant drug toxicity. It is a
suboptimal treatment modality.
New tests have recently been developed to diagnose Invasive Aspergillosis. These tests are
for the detection of an Aspergillus protein in blood and for the detection of Aspergillus
DNA in blood. Available data suggests that these new tests make an early diagnosis and seem
to be able to monitor responses to treatment. However no study has been reported to date
which demonstrates that the use of these tests can impact on important patient outcomes.
This trial is being performed to determine whether the use of the new diagnostic tests to
guide antifungal therapy will help improve treatment of Invasive Aspergillosis, reduce drug
toxicity and reduce the death rate in the high-risk patients as compared with the current
standard method of diagnosis and treatment with EAFT.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06028451 -
ManagemEnt of Antifungal Drug in Invasive Aspergillosis:a Real-word Study
|
||
Completed |
NCT02394483 -
Single Ascending Oral Dose Study of F901318
|
Phase 1 | |
Completed |
NCT01128907 -
Galactomannan Antigen in Bronchoalveolar Lavage in the Diagnosis of Invasive Aspergillosis in Neutropenic Patients
|
N/A | |
Completed |
NCT00404092 -
Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis
|
Phase 2 | |
Recruiting |
NCT01386437 -
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
|
||
Withdrawn |
NCT02912026 -
Radiolabelled IV and Oral Metabolism Study of F901318
|
Phase 1 | |
Withdrawn |
NCT03095547 -
Drug/Drug Interactions With F901318
|
Phase 1 | |
Withdrawn |
NCT03076905 -
Pharmacokinetics of IV Formulation
|
Phase 1 | |
Completed |
NCT02737371 -
Multiple Ascending Oral Dose Study of F901318 in Healthy Subjects
|
Phase 1 | |
Terminated |
NCT00836875 -
A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children
|
Phase 3 | |
Active, not recruiting |
NCT00838643 -
Invasive Aspergillosis After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
|
N/A | |
Terminated |
NCT04876716 -
Azole-echinocandin Combination Therapy for Invasive Aspergillosis
|
Phase 3 | |
Recruiting |
NCT05101187 -
Olorofim Aspergillus Infection Study
|
Phase 3 | |
Enrolling by invitation |
NCT02104479 -
Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing
|
||
Not yet recruiting |
NCT05707832 -
A Study of ABCD for Injection in Subjects With Invasive Candidiasis and Invasive Aspergillus
|
Phase 3 | |
Recruiting |
NCT06382922 -
Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy
|
||
Terminated |
NCT02396225 -
Concentrations of Voriconazole in Blood and BAL-fluid After Inhalation and Oral Administration
|
N/A | |
Recruiting |
NCT00843804 -
Surveillance for Nosocomial Infections in Pediatric Cancer Patients
|
N/A | |
Completed |
NCT00334412 -
COMBISTRAT: AmBisome® in Combination With Caspofungin for the Treatment of Invasive Aspergillosis
|
Phase 4 | |
Completed |
NCT04550936 -
Patterns of Real-World Isavuconazole Use - a Study of Patients With Mucormycosis or Invasive Aspergillosis
|