Nebulized Amphotericin B Lipid Complex in Invasive Pulmonary Aspergillosis in Paediatric Patients With Acute Leukaemia
Invasive Pulmonary Aspergillosis, Lymphoblastic Leukaemia, Myeloblastic Leukaemia
About this trial
This is an interventional treatment trial for Invasive Pulmonary Aspergillosis focused on measuring Invasive pulmonary aspergillosis, IFI, Leukaemia, Leukemia, Pediatric, Paediatrics, Amphotericin B, Aspergillosis, Pulmonary Aspergillosis, Invasive Aspergillosis, Antifungal agents, Fungal infections, Invasive Fungal Infection
Eligibility Criteria
Inclusion Criteria:
- Age: patients between 3 and 18 years.
- Diagnosis of myeloblastic or lymphoblastic AL during intensive chemotherapy.
- Informed consent of parents/guardians and/or assent of the patient has been obtained.
Exclusion Criteria:
- Probable or proven invasive pulmonary fungal infection before entering the trial.
- Previous chronic renal impairment or baseline serum creatinine > 2.5 mg /dL
- Severe hepatic impairment.
- Moderate-severe asthma being treated pharmacologically.
- Antifungal treatment for filamentous fungi in the last 4 weeks.
- Participating or have participated in a clinical trial during the last 4 weeks.
- Mentally retarded
- Known allergy or hypersensitivity to the active ingredient of the study drug or to any of its excipients.
- Any serious concomitant disease that in the investigator's opinion could compromise the completion of the trial or affect the patient's tolerability to this treatment.
- Pregnancy (in women of fertile age).
- Breast-feeding.
Patients are defined as having probable IFI when their radiological image is suggestive of fungal infection and they have positive antigenemia for Aspergillus. IFI would be proven when the presence of Aspergillus is confirmed in aspirate culture or by lung biopsy.
Sites / Locations
- Hospital Sant Joan de Déu
Arms of the Study
Arm 1
Experimental
Amphotericin B (ABELCET®)
Drug: AMPHOTERICIN B Dosage form: Abelcet® 5mg/ml administered by inhalation. Dosage: 10 ml (50 mg) for the first week with a frequency twice a week. Dosage: from the second week onwards 5 ml (25 mg) with a frequency of a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3. Duration: 4-5 prophylaxis courses defined as each administration period during a neutropenia period, with a 4-6 weeks length considering the duration of neutropenia.