To Determine Whether Galactomannan Test Will Help to Detect Fungal Infections Early and Hence Start Treatment Early

• Status: Completed
• Trial end date: 2009-06-30
• Target enrollment: 0
• Participant gender: All

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. One of these infections is caused by a mold called Aspergillus and can be life threatening. Usually doctors give preventive antifungal therapy to try to lower the risk of this infection. Despite this, patients are still at risk of getting fungal infection. This study is thus designed to test Galactomannan - a component of cell wall of Aspergillus and hence detect and treat fungal infection early.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Singapore General Hospital
• Collaborator: National University Hospital, Singapore
• Treatments: Amphotericin B; Amphotericin B, deoxycholate drug combination; Deoxycholic Acid; Liposomal amphotericin B

Criteria

Inclusion Criteria:

1. 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

2. 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

3. Patients with severe aplastic anemia (SAA) receiving chemotherapy or immunosuppressive therapy using antithymocyte globulin

4. Patients receiving allogeneic/autologous hematopoeitic stem cell transplant (HSCT) using myeloablative conditioning regimens

5. Patients are at least 12 years of age, with Karnofsky score of 70%.?

6. 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 Criteria:

1. Patients who are human immunodeficiency virus (HIV) infected

2. Patients with uncontrolled bacteremia or active pulmonary infection at the time of randomisation

3. 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].

4. Patients receiving concomitant piperacillin/tazobactam or co-amoxyclavulinic acid

5. Patients on palliative chemotherapy

6. Patients with history of allergy to triazoles

7. Patients with prior history of anaphylactic reaction to conventional amphotericin B

8. 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

9. Patients with expected life-expectancy < 72 hours