Clinical trial · Interventional

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

A Phase II Trial to Evaluate the Safety and Tolerability of Nebulised Amphotericin B Lipid Complex (ABELCET®) in the Prophylaxis of Invasive Pulmonary Aspergillosis During Prolonged Neutropenia in Paediatric Patients With Acute Leukaemia

NCT01615809CI-TRIAL-00032264completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Invasive Pulmonary Aspergillosis	—	UNRESOLVED	—
Lymphoblastic Leukaemia	Acute Lymphoblastic Leukemia	ALIAS	0.90
Myeloblastic Leukaemia	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
AMPHOTERICIN B	Drug	Amphotericin B	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Amphotericin B (ABELCET®)
description
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.
interventionNames
1. Drug: AMPHOTERICIN B

Primary outcomes (1)

measure
Number of Participants With Adverse Events That Results in the Interruption of Treatment, as a Measure of Safety and Tolerability
timeFrame
at the Baseline visit (week 1) and during the Last week of treatment, up to 6 weeks
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).

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 3 Years
Maximum age: 17 Years

Show eligibility criteria text

Inclusion Criteria:

1. Age: patients between 3 and 18 years.
2. Diagnosis of myeloblastic or lymphoblastic AL during intensive chemotherapy.
3. Informed consent of parents/guardians and/or assent of the patient has been obtained.

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.

References

Publications (15)

BACKGROUNDAscioglu S, Rex JH, de Pauw B, Bennett JE, Bille J, Crokaert F, Denning DW, Donnelly JP, Edwards JE, Erjavec Z, Fiere D, Lortholary O, Maertens J, Meis JF, Patterson TF, Ritter J, Selleslag D, Shah PM, Stevens DA, Walsh TJ; Invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer; Mycoses Study Group of the National Institute of Allergy and Infectious Diseases. Defining opportunistic invasive fungal infections in immunocompromised patients with cancer and hematopoietic stem cell transplants: an international consensus. Clin Infect Dis. 2002 Jan 1;34(1):7-14. doi: 10.1086/323335. Epub 2001 Nov 26. PMID 11731939
BACKGROUNDWalsh TJ, Gonzalez C, Lyman CA, Chanock SJ, Pizzo PA. Invasive fungal infections in children: recent advances in diagnosis and treatment. Adv Pediatr Infect Dis. 1996;11:187-290. No abstract available. PMID 8718464
BACKGROUNDBlyth CC, Palasanthiran P, O'Brien TA. Antifungal therapy in children with invasive fungal infections: a systematic review. Pediatrics. 2007 Apr;119(4):772-84. doi: 10.1542/peds.2006-2931. PMID 17403849
BACKGROUNDBodey GP, Anaissie EJ, Elting LS, Estey E, O'Brien S, Kantarjian H. Antifungal prophylaxis during remission induction therapy for acute leukemia fluconazole versus intravenous amphotericin B. Cancer. 1994 Apr 15;73(8):2099-106. doi: 10.1002/1097-0142(19940415)73:83.0.co;2-n. PMID 8156515
BACKGROUNDLin SJ, Schranz J, Teutsch SM. Aspergillosis case-fatality rate: systematic review of the literature. Clin Infect Dis. 2001 Feb 1;32(3):358-66. doi: 10.1086/318483. Epub 2001 Jan 26. PMID 11170942
BACKGROUNDPerfect JR, Klotman ME, Gilbert CC, Crawford DD, Rosner GL, Wright KA, Peters WP. Prophylactic intravenous amphotericin B in neutropenic autologous bone marrow transplant recipients. J Infect Dis. 1992 May;165(5):891-7. doi: 10.1093/infdis/165.5.891. PMID 1569339

Registry

Dates and enrollment

Start: Oct 1, 2011
Primary completion: Jul 1, 2013
Completion: Jul 1, 2013
First posted: Jun 11, 2012
Last update posted: Mar 29, 2018
Results first posted: Oct 23, 2015
Enrollment: 32 (actual)
Lead sponsor: Fundació Sant Joan de Déu OTHER
Collaborators: Ministry of Health, Spain
Keywords: Invasive pulmonary aspergillosis, IFI, Leukaemia, Leukemia, Pediatric, Paediatrics, Amphotericin B, Aspergillosis, Pulmonary Aspergillosis, Invasive Aspergillosis, Antifungal agents, Fungal infections, Invasive Fungal Infection

Data updated 22 days agoSource updated Mar 29, 2018source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
Spain	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.