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Study on the Safety and Effectiveness of Opelconazole with Other Antifungal Treatments for Patients with Hard-to-Treat Lung Aspergillosis

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What is this study about?

This clinical trial is focused on studying a condition known as Refractory Invasive Pulmonary Aspergillosis, which is a serious lung infection that does not respond well to standard treatments. The study is testing a new treatment called PC945, which contains the active substance opelconazole. This treatment is delivered as a nebulizer suspension, meaning it is inhaled as a mist directly into the lungs. The trial will compare the effects of PC945 when used alongside other antifungal medications to a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate the safety and effectiveness of PC945 in combination with other antifungal therapies. Participants in the study will receive either the PC945 treatment or a placebo, in addition to their existing antifungal therapy. The study will last for up to 12 weeks, during which time researchers will monitor the participants’ responses to the treatment.

Throughout the study, the main focus will be on observing how well the treatment works in improving the condition of those with refractory invasive pulmonary aspergillosis. The goal is to determine if adding PC945 to the current treatment regimen can help achieve a better overall response in managing this challenging lung infection.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. This study aims to assess the safety and effectiveness of a medication called PC945 (also known as opelconazole) when used with other antifungal treatments for a lung condition called refractory invasive pulmonary aspergillosis.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying that your condition meets specific criteria, such as having a proven or probable diagnosis of the lung condition and not responding to previous antifungal treatments.

3 randomization

You will be randomly assigned to receive either the PC945 medication or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual medication.

4 medication administration

The medication or placebo will be administered through inhalation using a nebulizer. This is a device that turns liquid medicine into a mist, which you breathe in through a mask or mouthpiece.

The treatment will be given in addition to your existing antifungal therapy. The exact dosage and frequency will be explained to you by the study team.

5 monitoring and follow-up

Throughout the study, your health and response to the treatment will be closely monitored. This includes regular check-ups and assessments to track your progress and any side effects.

The study will last up to 12 weeks, with evaluations conducted to determine the effectiveness of the treatment.

6 completion of the study

At the end of the study period, a final assessment will be conducted to evaluate your overall response to the treatment.

The results will help determine the number of participants who experienced a complete or partial improvement in their condition.

Who Can Join the Study?

  • The participant must have a condition called Refractory Invasive Pulmonary Aspergillosis (IPA). This means the participant has a lung infection caused by a type of fungus, and it has not improved with standard treatment.
  • The participant’s IPA must be confirmed as either “proven” or “probable” according to specific medical guidelines. These guidelines are from the 2019 European Organization for Research and Treatment of Cancer/Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) or the 2010 International Society for Heart and Lung Transplantation (ISHLT).
  • The participant’s IPA must have not responded to adequate antifungal therapy, meaning the usual treatments have not worked.
  • Participants of all genders are eligible to join the study.
  • The study is open to adults, which typically means individuals aged 18 and older.
  • The study may include individuals considered part of a vulnerable population, which can mean people who might need extra protection or care.

Who Cannot Join the Study?

  • Patients who are not suffering from Refractory Invasive Pulmonary Aspergillosis cannot participate. This is a specific lung infection that does not respond to standard treatments.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. This refers to specific categories or classifications of patients that the study is focusing on.
  • Patients who are not able to follow the study procedures or comply with the study requirements cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are participating in another clinical trial cannot participate.
  • Patients who have a history of allergic reactions to the study medication cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hopital Necker Enfants Malades Paris France
Hospital Universitario Y Politecnico La Fe Valencia Spain
Medical University Of Vienna Vienna Austria
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Medical University Of Graz Graz Austria
Katholieke Universiteit te Leuven Leuven Belgium
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Hospital Universitario Virgen De Las Nieves Granada Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Hospital Clinic De Barcelona Barcelona Spain
Universita Degli Studi Di Brescia Brescia Italy
Cppexdajv Ugyscrjqduagdr Soqgokqli Woluwe-Saint-Lambert Belgium
Hjraguuv Uwezwkxfuyfil Mejmxat Do Vqeygfvqxj Santander Spain
Llshf Gntmsfc Hqfbprgq Oa Aamhaj Athens Greece
Uhonvshzks Hyktraqx Cyzhztc Cologne Germany
Anoojem Opetybnfllj Uajeernbxnbvr Sjjjtf Siena Italy
Gtibaz Uhvgupmhxz Fznsxqvgq Frankfurt Germany
Uybdhzdnlftfnnflmhzmb Whexuspzq Ami Wuerzburg Germany
Hxbcvcfp Vlvj dlfxmaad Barcelona Spain
Hmxesybx Uprawyvxmpdhfp Sibdusmhxr &snldef Hyjgben db Hjizojxzumd STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
15.04.2022
Belgium Belgium
Not recruiting
15.04.2022
France France
Not recruiting
15.04.2022
Germany Germany
Not recruiting
15.04.2022
Greece Greece
Not recruiting
15.04.2022
Italy Italy
Not recruiting
15.04.2022
Spain Spain
Not recruiting
15.04.2022

Trial locations

Investigated drugs:

PC945 is a medication that is being tested in this clinical trial. It is given through a nebulizer, which means it is inhaled directly into the lungs. This medication is being studied to see if it can help treat a lung infection called invasive pulmonary aspergillosis, which is difficult to treat with standard medications. The goal is to see if adding PC945 to the usual treatment can improve the condition of patients who have this infection.

Systemic antifungal therapy refers to the standard treatment that is already used to fight fungal infections in the body. These medications work throughout the entire body to help eliminate the fungus causing the infection. In this trial, systemic antifungal therapy is used alongside PC945 to see if the combination is more effective in treating the lung infection than the standard treatment alone.

Refractory Invasive Pulmonary Aspergillosis – This disease is a severe fungal infection of the lungs caused by the Aspergillus species, which is resistant to standard antifungal treatments. It typically occurs in individuals with weakened immune systems, such as those undergoing chemotherapy or organ transplants. The infection begins when the fungal spores are inhaled and settle in the lung tissues, leading to inflammation and tissue damage. As the disease progresses, it can cause symptoms like persistent cough, chest pain, and difficulty breathing. The condition may spread beyond the lungs to other parts of the body if not effectively managed. The progression of the disease can vary depending on the individual’s immune response and the effectiveness of any additional treatments.

Trial ID:
2024-511281-36-00
Protocol code:
PC_ASP_006
NCT ID:
NCT05238116
Trial Phase:
Therapeutic confirmatory (Phase III)

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