Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263315
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2005-12-07
Brief Title:
Inhalation of Liposomal Amphotericin B to Prevent Invasive Aspergillosis
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Nebulized Liposomal Amphotericin B Ambisome Versus Nebulized Placebo for the Prophylaxis of Invasive Pulmonary Aspergillosis in Haematological Patients With Prolonged Neutropenia A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase IIIII randomized double-blind study comparing the safety and the efficacy of a weekly administration of 25 mg nebulized AmBisome with nebulized placebo solution to prevent invasive pulmonary aspergillosis in neutropenic hemato-oncologic patients
Detailed Description:
The morbidity mortality and costs of invasive pulmonary aspergillosis IPA in neutropenic patients are high An effective intervention to prevent IPA would therefore be welcome The incidence of IPA in neutropenic hematology patients in our institution was recently estimated to be 5-10 Currently only HEPA filtration is routinely used for the prevention of IPA In 1988 Schmitt et al showed a significant delayed mortality in rat model of IPA when rats were treated with aerosolized conventional amphotericin-B amB two days before infection 1 Conventional amB may interfere with surfactant function in the lungs In contrast liposomal amphotericin-B contains phospholipids that are structurally related to surfactant and inhibits natural surfactant function only slightly Furthermore in rats mean concentrations of AmB in lungs were 37 times higher at day one and almost 6 times higher at day seven after a single dose treatment with aerosolized liposomal amB when compared with conventional AmB 2 Only one non-placebo controlled randomized clinical trial evaluated the prophylactic use of inhalation therapy with conventional amB for the prevention of IPA and a non-significant 43 reduction was observed 3 We postulate that the weekly inhalation of liposomal AmB in neutropenic hematology patients can prevent IPA
In this randomised placebo controlled clinical trial we compare the safety and efficacy of the administration of nebulized liposomal AmB 2xweek with placebo for the prevention of IPA in haematological patients with an expected duration of neutropenia of 10d To demonstrate a reduction in incidence of invasive pulmonary aspergillosis from 7 to 1 a total of 170 neutropenic episodes in each arm will be included power 80 two-tailed alfa005 The primary efficacy endpoint is the cumulative percentage of patients developing a proven or probable IPA Per protocol serum galactomannan levels are monitored 2xweek and a HR-CT of the lungs will be performed for unexplained fever 5d unresponsive to broad-spectrum antibiotic therapy EORTCMSG criteria are used for diagnosis of IPA The primary safety endpoint is a premature discontinuation of the study drug for 1week due to intolerance
In this randomised placebo controlled clinical trial we compare the safety and efficacy of the administration of nebulized liposomal AmB 2xweek with placebo for the prevention of IPA in haematological patients with an expected duration of neutropenia of 10d To demonstrate a reduction in incidence of invasive pulmonary aspergillosis from 7 to 1 a total of 170 neutropenic episodes in each arm will be included power 80 two-tailed alfa005 The primary efficacy endpoint is the cumulative percentage of patients developing a proven or probable IPA Per protocol serum galactomannan levels are monitored 2xweek and a HR-CT of the lungs will be performed for unexplained fever 5d unresponsive to broad-spectrum antibiotic therapy EORTCMSG criteria are used for diagnosis of IPA The primary safety endpoint is a premature discontinuation of the study drug for 1week due to intolerance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None