Status:
COMPLETED
To Determine Whether Galactomannan Test Will Help to Detect Fungal Infections Early and Hence Start Treatment Early
Lead Sponsor:
Singapore General Hospital
Collaborating Sponsors:
National University Hospital, Singapore
Conditions:
Aspergillosis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
Chemotherapy lowers the white blood cell count or weakens the immune system for a long time. This puts the patients at a high risk of getting a serious fungal infection of the internal organs or blood...
Detailed Description
The diagnosis of invasive Aspergillosis (IA) remains a challenge in the febrile neutropenic and the hematopoietic stem cell transplant (HSCT) recipients. Recent studies have shown that early diagnosis...
Eligibility Criteria
Inclusion
- Patients with newly diagnosed acute leukemia or high risk myelodysplastic syndrome (MDS) receiving induction chemotherapy with expected duration of neutropenia (absolute neutrophil count of \< 500/mL) of at least 10 days
- Patients with relapsed acute leukemia or MDS receiving salvage chemotherapy with expected duration of neutropenia (absolute neutrophil count of \< 500/mL) of at least 10 days
- Patients with severe aplastic anemia (SAA) receiving chemotherapy or immunosuppressive therapy using antithymocyte globulin
- Patients receiving allogeneic/autologous hematopoeitic stem cell transplant (HSCT) using myeloablative conditioning regimens
- Patients are at least 12 years of age, with Karnofsky score of 70%.?
- Patients on consolidation chemo regimens like HIDAC and HyperCVAD type B with expected duration of neutropenia (ANC \< 500/ml) of at least 10 days
Exclusion
- Patients who are human immunodeficiency virus (HIV) infected
- Patients with uncontrolled bacteremia or active pulmonary infection at the time of randomisation
- Patients with pre-existing proven and probable invasive fungal infections, according to the definitions of the invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer; Mycoses Study Group of the National Institute of Allergy and Infectious Disease \[10\].
- Patients receiving concomitant piperacillin/tazobactam or co-amoxyclavulinic acid
- Patients on palliative chemotherapy
- Patients with history of allergy to triazoles
- Patients with prior history of anaphylactic reaction to conventional amphotericin B
- Patients with serum levels of aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or bilirubin more than 5 times the upper limit of normal or renal impairment with calculated creatinine clearance \< 30ml/min
- Patients with expected life-expectancy \< 72 hours
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2009
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00361517
Start Date
June 1 2006
End Date
June 30 2009
Last Update
September 26 2018
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169608