| Eligibility |
Key Inclusion Criteria:
2. Participant has received either a single or double lung transplant but did not receive
any other organ transplant (e.g., heart, kidney, etc.) at the time of the lung
transplantation. History of prior transplant (>1 year) is acceptable
6a. (De novo prophylaxis immediately post transplant): participant must be ready to be
randomized and start anti-mold prophylaxis within 72 hours of returning to the intensive
care unit (ICU) after the transplant surgery or
6b. (Pre-emptive therapy): participant must meet all of the following:
- Aspergillus spp. colonization of the respiratory tract confirmed within 91 days (13
weeks) after a lung transplant. Colonization is defined according to the 2010
International Society for Heart Lung Transplantation (ISHLT) Consensus Statement
definition criteria for colonization
- Without evidence of pulmonary fungal disease
- Must be ready to start anti-mold medication within 96 hours after the positive
culture(s), galactomannan or polymerase chain reaction (PCR) result(s) were reported
Key Exclusion Criteria:
1. Participant would normally receive nebulized amphotericin B as the only mold active
antifungal agent as initial SoC prophylaxis or pre-emptive therapy
2. Fungal disease requiring systemic antifungal treatment at the time of transplant
3. Has received a mold active antifungal agent post-transplant (Note: a participant who
receives a mold active antifungal agent within 24 hours before, during, or after the
transplant procedure will not be excluded if the mold active medication was stopped
within 72 hours of returning to the ICU after the transplant surgery, or prior to
randomization (whichever happens first)
4. Has previously received opelconazole
5. Is receiving, or who is due to receive at any time during the study, an
investigational medicinal agent
6. Is participating, or who is due to participate at any time during the study, in a
therapeutic clinical trial. For any other trials (e.g. observational or using approved
medication), consultation with Pulmocide and the medical monitor is required.
7. Has an endobronchial stent in situ
8. Known history of allergy, hypersensitivity, or any previous serious reaction to any
component of the opelconazole formulation, azoles, echinocandins, or amphotericin B
9. Elevated alanine transaminase (ALT) or, aspartate transaminase (AST) > 5 x the upper
limit of normal (ULN)
10. Any known history or current evidence of alcohol or drug abuse that, in the
Investigator's opinion, would exclude the participant from participation in the study
12. Life expectancy is not expected to be sustained for the duration of the trial (16
weeks), in the opinion of the investigator
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
|
