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)

TerminadoFase 3ClinicalTrials.gov

ID: NCT05238116Tipo: INTERVENTIONALInicio: 14 de jun de 2022Fin estimado: 29 de dic de 2025

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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

Intervenciones

drug

PC945

Sterile aqueous liquid for Nebulization

drug

Placebo

Sterile aqueous liquid for Nebulization

Ubicaciones

Clinical Research Site

Caba, Buenos Aires, Argentina

Clinical Research Site

La Plata, Buenos Aires, Argentina

Clinical Research Site

Caba, Buenos Aries, Argentina

Clinical Research Site

Rosario, Santa Fe Province, Argentina

Clinical Research Site

Mendoza, Argentina

Patrocinadores

PrincipalPulmocide Ltd

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