Safety and efficacy of PC945 in combination with other antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis (Opera-T Study)

Phase 1

Conditions: Refractory invasive pulmonary aspergillosis (IPA)
MedDRA version: 20.0Level: LLTClassification code 10059259Term: Pulmonary aspergillosisSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2021-004554-32-GR

Lead Sponsor: Pulmocide Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 123

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

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 participates 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. Participants 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.