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Trial record 2 of 3 for:    "Acute Leukemia" | "Amphotericin B"

Nebulized Amphotericin B Lipid Complex in Invasive Pulmonary Aspergillosis in Paediatric Patients With Acute Leukaemia

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ClinicalTrials.gov Identifier: NCT01615809
Recruitment Status : Completed
First Posted : June 11, 2012
Results First Posted : October 23, 2015
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Ministry of Health, Spain
Information provided by (Responsible Party):
Fundació Sant Joan de Déu

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Invasive Pulmonary Aspergillosis
Lymphoblastic Leukaemia
Myeloblastic Leukaemia
Lymphoblastic Leukemia
Myeloblastic Leukemia
Intervention Drug: AMPHOTERICIN B
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Amphotericin B (ABELCET®)
Hide Arm/Group Description

Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).

AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3.

Period Title: Overall Study
Started 32 [1]
Completed 22
Not Completed 10
[1]
basal visit
Arm/Group Title Amphotericin B (ABELCET®)
Hide Arm/Group Description

Patients fulfilling inclusion criteria and those giving the general informed consent for the study initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).

AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization was 10 ml (50 mg) twice a week for the first week, and then from the second week onwards was reduced to 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count demonstrated to be greater than or equal to 1500 cells/mm3.

Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
pediatric patients
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
>= 3 years to <=18 years Number Analyzed 32 participants
32
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
13
  40.6%
Male
19
  59.4%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
caucasian 27
amerindian 2
african 1
gypsies 2
[1]
Measure Description: patients ethnicity percentage : caucasian (84.4%), Amerindian (6.3%), African (3.1%) and gypsies (6.3%).
Region of Enrollment  
Measure Type: Number
Unit of measure:  Center
Spain Number Analyzed 32 participants
32
1.Primary Outcome
Title Number of Participants With Adverse Events That Results in the Interruption of Treatment, as a Measure of Safety and Tolerability
Hide Description is assessed by the proportion of patients who discontinue prophylactic treatment with Abelcet® due to an adverse event that is related or not to the study drug or for intolerability to it. The last week of treatment will have a different calendar for each participant, depending on the number of cicles needed by each patient (it has been anticipated up to 5 cicles of 2-6 weeks each).
Time Frame at the Baseline visit (week 1) and during the Last week of treatment, up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
pediatric patients
Arm/Group Title Amphotericin B (ABELCET®)
Hide Arm/Group Description:

Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).

AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3.

Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Efficacy of Primary Prophylaxis With Nebulized Abelcet® on the Incidence of Invasive Pulmonary Aspergillosis
Hide Description The incidence of invasive pulmonary aspergillosis during the Abelcet® prophylactic treatment period was assessed by the relation between the number of patients with invasive pulmonary aspergillosis and the number of paediatric patients on prophylaxis with Acute Leukaemia (AL) undergoing intensive chemotherapy.
Time Frame at the Baseline visit (week 1) and at the end of the profilaxis treatment phase, up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
At baseline, none of the 32 pediatric patients with acute leukemia included in the clinical trial had API. During the trial period there were 3 patients who developed API
Arm/Group Title Amphotericin B (ABELCET®)
Hide Arm/Group Description:

Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).

AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3.

Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
3
3.Secondary Outcome
Title Invasive Pulmonary Aspergillosis -Related Mortality During Primary Prophylaxis With Abelcet®.
Hide Description Percentage of deaths related to Invasive Pulmonary Aspergillosis during the prophylactic treatment period with Abelcet® in paediatric patients with Acute Leukaemia undergoing intensive chemotherapy.
Time Frame at the Baseline visit (week 1) and at the end of the profilaxis treatment phase, up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amphotericin B (ABELCET®)
Hide Arm/Group Description:

Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).

AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3.

Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of deaths
0
(0 to 0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amphotericin B (ABELCET®)
Hide Arm/Group Description

Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).

AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3.

All-Cause Mortality
Amphotericin B (ABELCET®)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Amphotericin B (ABELCET®)
Affected / at Risk (%) # Events
Total   22/32 (68.75%)    
Blood and lymphatic system disorders   
febrile neutropenia   16/32 (50.00%)  26
Febrile Aplasia   3/32 (9.38%)  3
macroscopic hematuria   1/32 (3.13%)  3
General disorders   
fever   8/32 (25.00%)  13
Metabolism and nutrition disorders   
hyperglycemia   2/32 (6.25%)  3
Nervous system disorders   
Methotrexate-induced neurotoxicity   3/32 (9.38%)  3
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Amphotericin B (ABELCET®)
Affected / at Risk (%) # Events
Total   32/32 (100.00%)    
Gastrointestinal disorders   
abdominal pain   29/32 (90.63%)  32
diarrhea   21/32 (65.63%)  32
General disorders   
Fever   32/32 (100.00%)  32
paleness   28/32 (87.50%)  32
physical pain   24/32 (75.00%)  32
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rosa Maria morales Palau
Organization: Fundaciò per la Recerca i la Docencia sant Joan de Deu
Phone: 936009751
EMail: rmorales@fsjd.org
Publications:
Layout table for additonal information
Responsible Party: Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier: NCT01615809     History of Changes
Other Study ID Numbers: FSJD-ABELNEB-2010
First Submitted: June 4, 2012
First Posted: June 11, 2012
Results First Submitted: August 28, 2015
Results First Posted: October 23, 2015
Last Update Posted: March 29, 2018