Phase 2
N=32
Nebulized Amphotericin B Lipid Complex in Invasive Pulmonary Aspergillosis in Paediatric Patients With Acute Leukaemia
Invasive Pulmonary Aspergillosis · Lymphoblastic Leukaemia · Myeloblastic Leukaemia · Lymphoblastic Leukemia · Myeloblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01615809 ↗Enrolled (actual)
32
Serious AEs
68.8%
Results posted
Oct 2015
Primary outcome: Primary: Number of Participants With Adverse Events That Results in the Interruption of Treatment, as a Measure of Safety and Tolerability — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AMPHOTERICIN B (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Fundació Sant Joan de Déu
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events That Results in the Interruption of Treatment, as a Measure of Safety and Tolerability |
— | — |
| SECONDARY Efficacy of Primary Prophylaxis With Nebulized Abelcet® on the Incidence of Invasive Pulmonary Aspergillosis |
3 | — |
| SECONDARY Invasive Pulmonary Aspergillosis -Related Mortality During Primary Prophylaxis With Abelcet®. |
— | — |
Summary
The trial evaluates the overall tolerability of the drug and the efficacy of aerosolised amphotericin B as a lipid complex (ABLC) for primary prophylaxis of invasive pulmonary aspergillosis (IPA) in pediatric patients with acute leukemia undergoing intensive chemotherapy.
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.
Data sourced from ClinicalTrials.gov (NCT01615809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.