Invasive pulmonary aspergillosis in patients with acute myeloblastic or lymphoblastic leukaemia. MedDRA version: 14.0 Level: LLT Classification code 10022881 Term: Invasive bronchopulmonary aspergillosis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: ABELCET 5 mg/ml
Pharmaceutical Form: Suspension for infusion
CAS Number: 1397-89-3
Other descriptive name: AMPHOTERICIN B
Concentration unit: mg/ml milligram(s)/millilitre
Concentration ty
Sponsors
FUNDACIÓ SANT JOAN DE DEU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: patients between 3 and 18 years. 2. Diagnosis of myeloblastic or lymphoblstic AL during intensive chemotherapy. 3. Informed consent of parents/guardians and/or assent of the patient has been obtained. Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Probable or proven invasive pulmonary fungal infection before entering the trial. 2.Previous chronic renal impairment or baseline serum creatinine > 2.5 mg /dL 3.Severe hepatic impairment. 4.Moderate-severe asthma being treated pharmacologically. 5.Antifungal treatment for filamentous fungi in the last 4 weeks. 6.Participating or have participated in a clinical trial during the last 4 weeks. 7.Mentally retarded 8.Known allergy or hypersensitivity to the active ingredient of the study drug or to any of its excipients. 9.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. 10.Pregnancy (in women of fertile age). 11.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the overall tolerability of the drug, defined as any adverse event that results in the interruption of treatment, during primary prophylaxis with nebulized ABLC, in paediatric patients with acute leukaemia (AL) undergoing intensive chemotherapy.;Secondary Objective: 1.To evalute the efficacy of primary prophylaxis with nebulized ABLC on the incidence of invasive pulmonary aspergillosis (IPA) in paediatric patients with LA undergoing intensive chemotherapy. 2.To determine the IPA-related mortality during primary prophylaxis with ABLC in paediatric patients with (AL) undergoing intensive chemotherapy.;Primary end point(s): The primary efficacy variable will be the proportion of patients who discontinue prophylactic treatment with ABLC due to an adverse event that is related or not to the study drug or for intolerability to it.;Timepoint(s) of evaluation of this end point: They will be analysed by homogeneity tests comparing the results with those of a historical cohort. The hypothesis tests and confidence intervals will be calculated by exact methods given the low sample size. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary variables to be obtained are the following: -Proportion of discontinued drug administrations due to a treatment-related adverse event or intolerability to treatment (number of discontinued administrations/ number of administrations started) -Total number of IPA cases -Incidence of IPA during the ABLC (Abelcet®) prophylactic treatment period (number of patients with IPA/number of patients on prophylaxis). -IPA incidence rate during the ABLC prophylactic treatment period (number of patients with aspergillosis/time on prophylaxis of study patients). -Mortality due to IPA -Percentage of deaths during the prophylactic treatment period and cause of death.;Timepoint(s) of evaluation of this end point: For the analysis of patients who died due to IPA or other causes a Kaplan-Meier survival analysis will be performed. The median survival time and the % of cumulative survival will be estimated with their respective 95% confidence intervals. The 95% confidence interval (95% CI) will be calculated for the presence/absence of toxicity and toxicity severity (CTCAE grades 1 to 4) variable. All the adverse events will be listed giving their severity and relation to the study drug. The categorical variables will be will be summarised by frequency distributions whilst the central tendency and dispersion will be given for the quantitative variables and, if appropriate, their 95% confidence intervals (95% CI). | — |
Countries
Spain
Contacts
Public ContactFUNDACIÓ SANT JOAN DE DEU
FUNDACIÓ SANT JOAN DE DEU
Outcome results
None listed