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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Spain
Information provided by (Responsible Party):
Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier:
NCT01615809
First received: June 4, 2012
Last updated: November 4, 2015
Last verified: November 2015
Results First Received: August 28, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Invasive Pulmonary Aspergillosis
Lymphoblastic Leukaemia
Myeloblastic Leukaemia
Lymphoblastic Leukemia
Myeloblastic Leukemia
Intervention: Drug: AMPHOTERICIN B

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Amphotericin B (ABELCET®)

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.


Participant Flow:   Overall Study
    Amphotericin B (ABELCET®)
STARTED   32 [1] 
COMPLETED   22 
NOT COMPLETED   10 
[1] basal visit



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
pediatric patients

Reporting Groups
  Description
Amphotericin B (ABELCET®)

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.


Baseline Measures
   Amphotericin B (ABELCET®) 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age, Customized 
[Units: Participants]
 
>= 3 years to <=18 years   32 
Gender 
[Units: Participants]
 
Female   13 
Male   19 
Race/Ethnicity, Customized [1] 
[Units: Participants]
 
caucasian   27 
amerindian   2 
african   1 
gypsies   2 
[1] patients ethnicity percentage : caucasian (84.4%), Amerindian (6.3%), African (3.1%) and gypsies (6.3%).
Region of Enrollment 
[Units: Center]
 
Spain   32 


  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events That Results in the Interruption of Treatment, as a Measure of Safety and Tolerability   [ Time Frame: at the Baseline visit (week 1) and during the Last week of treatment, up to 6 weeks ]

2.  Secondary:   Efficacy of Primary Prophylaxis With Nebulized Abelcet® on the Incidence of Invasive Pulmonary Aspergillosis (IPA) in Paediatric Patients 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 ]

3.  Secondary:   Invasive Pulmonary Aspergillosis (IPA)-Related Mortality During Primary Prophylaxis With Abelcet® in Paediatric Patients With (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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Rosa Maria morales Palau
Organization: Fundaciò per la Recerca i la Docencia sant Joan de Deu
phone: 936009751
e-mail: rmorales@fsjd.org


Publications:


Responsible Party: Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier: NCT01615809     History of Changes
Other Study ID Numbers: FSJD-ABELNEB-2010
Study First Received: June 4, 2012
Results First Received: August 28, 2015
Last Updated: November 4, 2015
Health Authority: Spain: Spanish Agency of Medicines
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Ministry of Health