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Azole Antifungal
Opelconazole for Pulmonary Aspergillosis
Phase 2
Waitlist Available
Research Sponsored by Pulmocide Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a medication called opelconazole to prevent lung infections caused by Aspergillus fungus in people who have had a lung transplant. The study will last for several months, followed by a safety check. Opelconazole works by stopping the fungus from growing in the lungs, helping to prevent serious infections.
Eligible Conditions
- Pulmonary Aspergillosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: OpelconazoleExperimental Treatment1 Intervention
14.8 mg opelconazole administered twice daily for 12 weeks
Group II: Standard of Care (SoC)Active Control1 Intervention
Mold-active SoC prophylaxis/pre-emptive therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Opelconazole
2021
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
Pulmocide LtdLead Sponsor
9 Previous Clinical Trials
423 Total Patients Enrolled
1 Trials studying Pulmonary Aspergillosis
123 Patients Enrolled for Pulmonary Aspergillosis
Vice President Clinical DevelopmentStudy DirectorPulmocide Ltd
1 Previous Clinical Trials
100 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a tube called an endobronchial stent in your airway.You don't have any signs of a lung infection caused by fungus.You have a fungal infection that needs strong medicine to treat it throughout the trial.You have had a bad reaction or allergy in the past to any of the ingredients in the PC945 drug, or to similar types of medications like azoles, echinocandins, or amphotericin B.
Research Study Groups:
This trial has the following groups:- Group 1: Opelconazole
- Group 2: Standard of Care (SoC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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