Intermittent Liposomal Amphotericin B Primary Prophylaxis

Launched by BAYSIDE HEALTH · Mar 21, 2007

Keywords

ClinConnect Summary

Invasive Fungal Infections (IFI)are a significant cause of death in patients with acute leukaemia who are undergoing chemotherapy. This is despite improvements in antifungal therapy for the treatment of IFI. The major reason for this is that the current standard diagnostic tests of culture and biopsy lack the ability to make a diagnosis, either early or accurately. Thus other strategies such as the use of prophylaxis are needed. Several antifungal agents have been trialled as prophylaxis but all have disadvantages that limit their effectiveness.

Liposomal amphotericin B(LAB) is a broad spe...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients fulfilling all the following criteria will be eligible:
• • Male or female aged \>18years;
• • Newly diagnosed with acute myeloid leukaemia and undergoing first induction chemotherapy regimen;
• • Expected to have absolute neutrophil counts of \<0.5x109/L for at least 2 weeks;
• • Normal high resolution chest and sinus CT scan at baseline;
• • No signs or symptoms of invasive fungal infections
• • No prior diagnosis of proven or probable invasive fungal infection within the last 6 months;
• • Females of childbearing potential must be: surgically incapable of pregnancy; or practicing an acceptable mode of birth control and have a negative pregnancy test (blood or urine) at baseline;
• • Give written informed consent prior to any study-specific procedures;
• • Must have the ability and must agree to comply with all study requirements.
• Exclusion Criteria:
• • Patients with any of the following will be ineligible
• • Known hypersensitivity to amphotericin B, in particular known history of anaphylactic reaction to amphotericin B;
• • Patients undergoing any transplantation;
• • Creatinine clearance \<60mL/min/1.72 m2;
• • Patients with moderate or severe liver disease as defined by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times the upper limit of normal (ULN)
• • Patients who are unlikely to survive more than one month;
• • Patients who have received systemic antifungal therapy within the last 15 days
• • Any severe cardiovascular disease ( in particular arrhythmias) which may constitute a contra-indication to LAB (AmBisome®) administration;
• • Any severe diseases other than acute myeloid leukaemia which in the investigator's judgement may interfere with study evaluations or affect the patients safety;
• • Pregnant or nursing females;
• • Patients previously included in this study;
• • Patients who have taken an investigational drug in the last 30 days prior to the inclusion.
• • Patients enrolled in a pre-emptive treatment strategy trial