Nebulised Liposomal Amphotericin for Invasive Pulmonary Aspergillosis (NAIFI01 Study)
Status:
Recruiting
Trial end date:
2022-10-30
Target enrollment:
Participant gender:
Summary
The investigators aim to assess the safety and efficacy of nebulized liposomal amphotericin B
(ALN) as a complementary therapy to the usual systemic treatment in patients with invasive
pulmonary aspergillosis and the utility of a non-routine test as a surrogate marker of
efficacy. To this end, a 3-year phase I, prospective, randomized and controlled clinical
trial will be carried out in a single center, in patients with proven or probable pulmonary
aspergillosis receiving routine systemic treatment. Participants will be randomized ( 1: 1)
to receive ALN, 25 mg or nebulizer injection water 3 times a week, for 6 weeks. The primary
objective is the safety of ALN in this scenario, including clinical tolerance and
pharmacokinetic studies. Secondary objectives are presented as: a) clinical efficacy, using
the following criteria: complete response, partial response, stability and progression or
death, on week 12; b) microbiological efficacy, using culture, galactomannan, BDGlucan and
Aspergillus PCR in induced sputum on week +6; and c) to explore the utility of the SUV
("standardized uptake value") index in PET-CT performed on week +6 in relation to a baseline
PET-CT as a surrogate marker of response. The administration of ALN and placebo will be
carried out by eFlowR vibrating membrane electronic nebulizers. To carry out the study, the
following visits will be made: baseline, week 1,2,3,4,5,6 (efficacy and safety evaluation), 9
and 12 (overall evaluation).
Phase:
Phase 1
Details
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal