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Testing a new antifungal treatment for severe lung infections

A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Efficacy of Nebulized PC945 When Added to Systemic Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)

Phase 3 Interventional Pulmocide Ltd · NCT05238116

This study tests a new antifungal treatment for severe lung infections to see if it can help patients whose infections haven't improved with standard treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment123 (estimated)
Ages18 Years and up
SexAll
SponsorPulmocide Ltd Industry-sponsored
Locations98 sites (Duarte, California and 97 other locations)
Trial IDNCT05238116 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of nebulized PC945, an antifungal medication, when used alongside systemic antifungal therapy for patients suffering from refractory invasive pulmonary aspergillosis (IPA). The study aims to determine if this combination can improve treatment outcomes for patients whose infections have not responded to standard antifungal treatments. Participants will be monitored for safety and efficacy throughout the trial period.

Who should consider this trial

Good fit: Ideal candidates are individuals with proven or probable invasive pulmonary aspergillosis who have not responded to previous antifungal therapies.

Not a fit: Patients with known allergies to PC945 or those who have previously received this treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with difficult-to-treat lung infections caused by fungi.

How similar studies have performed: Other studies have explored antifungal therapies for invasive pulmonary aspergillosis, but the specific combination of nebulized PC945 with systemic therapy is a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participant has proven or probable IPA according to the modified 2019 European Organization for Research and Treatment of Cancer/ Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) consensus definitions or according to the 2010 International Society for Heart and Lung Transplantation (ISHLT) consensus statements for the definitions of infections in cardiothoracic transplant recipients.
2. Participant's IPA has failed to respond to adequate antifungal therapy.

Exclusion Criteria:

1. Participant with a known or suspected 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 Participant should he/she participate in the study.
2. Participant who has previously received PC945.
3. Participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 or placebo formulations.
4. Participant who has recently received, is receiving or due to receive at any time during the study, an investigational medicinal agent that does not have any regulatory approved indications. Subjects who are participating in any other trials e.g., Observational, diagnostic or using medications with an approved indication may be allowed to participate after consultation with the sponsor on an individual basis

Where this trial is running

Duarte, California and 97 other locations

+48 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Refractory IPAinvasive pulmonary aspergillosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.