TerminatedPhase 3

Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)

Stopped: The study was terminated by the Sponsor based on a sample size recalculation interim analysis which showed a numerically lower favorable response rate and a numerically higher mortality rate in the opelconazole arm compared to the control arm.

United States85 participantsStarted 2022-06-14

Plain-language summary

To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Participant's IPA has failed to respond to adequate antifungal therapy.

Exclusion criteria

✕. 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.
✕. Participant who has previously received PC945.
✕. Participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 or placebo formulations.
✕. 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

What they're measuring

Number of Participants Alive With Favorable Overall Response as Assessed by the Data Review Committee (DRC)

Timeframe: At Day 84

Trial details

NCT IDNCT05238116

SponsorPulmocide Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-29

Results submitted2026-04-10

View on ClinicalTrials.gov More Refractory IPA trials