Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria:
1. Subject is ≥ 18 years.
2. Subject 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.
3. Subject or Legally Authorized Representative has provided written or electronic informed consent in a manner approved by the applicable Institutional Review Board
(IRB) or Ethics Committee.
4. Subject is able to perform and willing to comply with the study visits, laboratory assessments, and other study-related procedures.
5. Females of child-bearing potential must be non-lactating, must have a negative pregnancy test at screening, and must agree to be abstinent or to use contraception until 30 days after the last dose of PC945 or of SoC anti-mold prophylaxis or pre-emptive therapy.
6a. Cohort 1 (de novo prophylaxis immediately post transplant): subject must dose within 72 hours of returning to the ICU after transplant surgery (extended from 48 hours)
6b. In Cohort 2 (pre-emptive therapy): subject 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 ISHLT
Consensus Statement definition criteria for colonization.
- Without evidence of pulmonary fungal disease.
- Must be ready to start anti-mold medication within 72 hours after the positive culture(s), galactomannan or PCR result(s) were reported.
Exclusion Criteria:
1. Subject who would normally receive nebulized amphotericin B as the only mold active antifungal agent as initial SoC prophylaxis or pre-emptive therapy.
2. Subject with a fungal disease requiring systemic antifungal treatment at the time of transplant.
3. Subject has received a mold active antifungal agent post transplant. Subject must dose within 96 hours after positive culture(s), galactomannan or PCR results are reported (extended from 72 hours).
Note: a subject 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 48 hours of returning to the ICU after the transplant surgery, or prior to randomization (whichever happens first).
4. Subject who has previously received PC945.
5. Subject who is receiving, or who is due to receive at any time during the study, an investigational medicinal agent.
6. Subject who 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. Subject has an endobronchial stent in situ.
8. Subject with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 formulation, azoles, echinocandins, or amphotericin B.
9. Subject with an elevated alanine transaminase (ALT) or, aspartate transaminase (AST) > 5 x the upper limit of normal (ULN).
10. Subject with any known history or current evidence of alcohol or drug abuse that, in the Investigator's opinion, would exclude the subject from participation in the study.
11. Subject with a concomitant medical condition or post-surgery complication that, in the opinion of the Investigator, may jeopardize adherence to the protocol requirements or
impede the accurate measurement of efficacy or may be an unacceptable additional risk to the subject should he/she participate in the study.
12. Subject's life expectancy is not expected to be sustained for the duration of the trial (16 weeks), in the opinion of the investigator.
13. In Cohort 2 (pre-emptive therapy), subject colonized with a documented azole-, echinocandin-, or amphotericin B resistant Aspergillus organism or with any non Aspergillus mold.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/27/23. Questions regarding updates should be directed to the study team contact.