Aspergillosis

Researchers are evaluating the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis (ABPA), a condition that often affects people with severe bronchial asthma. The study follows guidelines from ISHAM for ABPA diagnosis and treatment, aiming to understand how biologics can impact this condition. This is a prospective, multicenter observational cohort study sponsored by Qianfoshan Hospital. Participants receive standard medical treatment consisting of oral prednisone with a tapering dose over several weeks, with or without oral voriconazole. Some patients also receive biological agents combined with this standard therapy for at least four months, following GINA2025 guidelines. The biologics are given alongside existing asthma treatments, such as inhaled corticosteroids and long-acting beta-agonists. The study compares groups receiving biologics plus standard treatment versus standard treatment alone. During the study, researchers monitor participants for one to two years, assessing the number of exacerbations, hospitalizations, time to first exacerbation, remission rates, glucocorticoid use, asthma control, and various immune markers such as serum IgE and eosinophil counts. Safety and overall mortality are also tracked. This extensive follow-up includes measuring treatment responses at eight weeks and ongoing assessments to evaluate long-term effects and disease control.

Researchers are evaluating treatments for acute allergic bronchopulmonary aspergillosis (ABPA), a condition complicating asthma. This trial aims to compare whether a combination of prednisolone and itraconazole reduces the rate of exacerbations within one year better than either prednisolone or itraconazole alone. The study follows 300 adults aged 18 years and older diagnosed with acute ABPA, assessing the impact of these treatments on disease flare-ups. Participants will be randomly assigned to one of three groups: prednisolone alone, itraconazole alone, or a combination of both. Prednisolone is given orally in a tapering dose over four months, and itraconazole is given orally twice daily for four months with dose adjustments based on blood levels. The combination group receives both treatments simultaneously for the same duration. Therapeutic drug monitoring for itraconazole is performed at two weeks and two months. During the study, participants undergo baseline tests including demographic, immune, and imaging assessments. Follow-up visits occur every two months initially, then every four months for a total of five visits after treatment completion. Researchers track asthma and ABPA exacerbations over 12 months as the primary outcome. Secondary outcomes include immune response, time to first exacerbation, weight gain, blood sugar changes, and liver function. The study also monitors safety and treatment effects throughout the trial period.

Researchers are evaluating the efficacy and safety of bronchoscopic airway clearance combined with amphotericin B spraying for patients with allergic bronchopulmonary aspergillosis (ABPA). This study compares this procedure along with standard drug therapy against standard therapy alone, aiming to improve treatment outcomes such as symptom remission and immunological response. The study is observational and involves patients diagnosed with active ABPA, including newly diagnosed cases or acute exacerbations. Participants in the observation group will receive standard drug treatment, which includes oral glucocorticoids with or without oral antifungal drugs, along with bronchoscopic airway clearance and amphotericin B spraying. The control group will receive only the standard drug therapy while maintaining previous asthma treatments like inhaled corticosteroids and long-acting beta-agonists. The bronchoscopic procedure is performed based on mucus plug removal effectiveness and is given at least once. Both groups continue their usual asthma medications. Participants will be monitored for radiographic response, immunological remission, and clinical symptom remission after 4 months of treatment. Additional outcomes include acute exacerbations, hospitalizations, quality of life, immunological markers, psychological assessments, and mortality tracked up to 2 years. The study includes imaging, blood tests, and symptom evaluations to assess treatment effects and safety over time. The total participation period includes treatment and long-term follow-up for comprehensive outcome measurement.

Chronic Pulmonary Aspergillosis (CPA) is a serious lung disease caused by the fungus Aspergillus, primarily affecting people with damaged lungs such as those recovering from tuberculosis. CPA has a high mortality rate and is often misdiagnosed as tuberculosis, leading to delays in proper antifungal treatment. This trial aims to evaluate the use of nebulized amphotericin B as maintenance therapy to reduce relapse and prolong time to relapse in CPA patients who have completed 12 months of oral itraconazole treatment. Participants will be randomly assigned to receive either nebulized amphotericin B deoxycholate twice daily or nebulized normal saline as a placebo. The amphotericin B is prepared by mixing a specific dose with distilled water to ensure full nebulization. The study compares these two inhalation treatments to see which better maintains health after initial oral antifungal therapy, with treatments continuing as maintenance following 12 months of oral itraconazole. Throughout the 12 months following randomization, participants will be closely monitored for time to first exacerbation, frequency of relapses, and any treatment-related side effects. Assessments include clinical evaluations and safety monitoring to determine the effects of the nebulized treatments as maintenance therapy. This trial will help understand the potential benefits and safety of inhaled amphotericin B in managing CPA over a year-long period.

Researchers are developing and managing the AnovaOS Network Powered Patient Registry to collect real-world patient data across various diseases globally. This registry aims to capture meaningful clinical information on diagnosis, infection course, treatments, and outcomes to enhance understanding and support future clinical trials and observational studies. The registry serves as a resource to better understand, prevent, diagnose, and treat diverse health conditions. Participants' data will be gathered through this registry, which can also be used to recruit individuals for clinical trials and observational studies on promising therapies. The registry collects ongoing information on patients' health status and treatments, enabling long-term monitoring and analysis. This observational study does not involve administering treatments but focuses on data collection and management. Participants will provide information through questionnaires or instruments, either personally or via an informed proxy, with an expected follow-up once per year. The research team will assess natural history, clinical effectiveness, safety, and quality of care over a period of five years. The registry includes patients with a wide range of conditions, and participation requires informed consent and the ability to complete follow-up data collection.

Researchers are evaluating a new diagnostic test for mucormycosis, a serious invasive fungal infection caused by fungi in the Mucorales order. This infection has a high mortality rate between 20% and 60% depending on its location. Early diagnosis and prompt antifungal treatment are critical. The study focuses on detecting specific biomarkers found in the fungal cell wall to improve diagnosis accuracy among patients with mucormycosis and control groups including high-risk patients without mucormycosis and those with other invasive fungal infections. The study involves three groups: patients diagnosed with mucormycosis, high-risk patients without mucormycosis assessed before hematopoietic stem cell transplantation, and patients with other invasive fungal infections like candidiasis or aspergillosis. Venous blood samples are collected at multiple time points: Day 0 (diagnosis day), Day 3, Day 7, Day 14, and Day 28 to measure biomarker levels. These measures aim to assess the presence and changes of the biomarker over time. Participants will undergo regular blood sampling and clinical evaluation during hospitalization. The main outcome is the biomarker values measured as optical density on Day 0, with follow-up measurements on Days 3, 7, 14, and 28 to observe biomarker kinetics. Researchers will also track clinical outcomes such as death at 28 days. The total participation duration varies but includes assessments through the first 28 days after diagnosis or enrollment.

Patients with leukemia and neutropenia are at high risk for invasive fungal infections (IFI), which can lead to serious health problems and high mortality. Due to severe thrombocytopenia, invasive diagnostic procedures are often too risky for these patients. Diagnosis usually relies on lung findings from computed tomography and serologic tests for fungal components, but these methods have limited accuracy. This research aims to identify specific volatile biomarkers in the breath of leukemia patients with proven or probable IFI using a technology called secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS). The study observes patients grouped by their IFI status according to EORTC guidelines: no IFI, possible IFI (clinical or radiological suspicion without microbiological proof), probable IFI (clinical or radiological suspicion with indirect microbiological evidence), and proven IFI (definitive histological or microbiological evidence). The investigational approach involves analyzing patients’ breath samples with SESI-HRMS to detect volatile biomarkers linked to IFI. Participants will provide breath samples during their hospital stay, typically lasting two weeks or longer due to chemotherapy. Researchers will measure novel biomarkers in breath over about three weeks to evaluate their ability to detect IFI. They will assess the sensitivity and specificity of these biomarkers and how early IFI can be anticipated. The study is observational, focusing on collecting and analyzing breath metabolome data without altering patient treatment.

Researchers are comparing the effects of two treatments for Chronic Pulmonary Aspergillosis (CPA) in adults who are not or only mildly immunocompromised. The study evaluates the clinical and radiological outcomes of a six-month therapy combining itraconazole with nebulised Ambisome4 (liposomal amphotericin B) against itraconazole alone. Patients with single aspergilloma are excluded from this study, which is a prospective, randomized, single-blind phase 3 trial sponsored by Poitiers University Hospital. Participants are assigned to one of two groups: the control group receives itraconazole 200 mg twice daily plus an inactive nebulised treatment (isotonic saline) twice weekly for 24 weeks, while the experimental group receives the same itraconazole dose combined with inhaled liposomal amphotericin B at 25 mg twice weekly for 24 weeks. The study includes a 24-month follow-up period after treatment ends, with a minimum follow-up of 12 months. During the study, participants will undergo clinical and radiological assessments to measure improvement or stability after six months of treatment. Additional evaluations include monitoring major events, relapse rates, and mycological response over 30 months. The primary outcome focuses on a composite measure of clinical and radiological improvement at six months. Safety and treatment adherence will be closely monitored throughout the study period.

This research focuses on invasive aspergillosis (IA), a common fungal infection affecting immunocompromised patients with blood-related diseases. The study aims to improve diagnosis by detecting mutations in fungal DNA that cause resistance to azole drugs, which are the main treatments for IA. This is especially important in the Netherlands, where resistance is common and linked to high mortality rates. Participants will have Aspergillus PCR tests performed on different volumes of their serum and plasma. These tests seek to quickly identify azole resistance mutations directly from blood samples, bypassing slower fungal cultures. The study evaluates the performance of two PCR tests, compares different media used in these tests, and determines the optimal PCR cycle threshold within one week. During the study, participants undergo lung CT scans and bronchoalveolar lavage as part of their care. Researchers collect blood samples for PCR testing and assess test performance shortly after. The primary outcomes focus on how well the PCR tests detect resistance mutations. Participants must be adults with specific lung lesions and planned or recent lavage. The study excludes those unable or unwilling to provide consent.

Mycotic sinusitis is a rare inflammatory condition affecting the paranasal sinuses, with rising cases in recent years. It includes non-invasive forms such as mycetoma and allergic mycotic sinusitis, often involving the maxillary sinus. Diagnosing this fungal sinusitis is challenging due to nonspecific symptoms like nasal obstruction and pain, and sometimes patients have no symptoms. Improving diagnosis is important as current methods rely on clinical signs, endoscopic findings, and CT scans, which have limitations in specificity. Patients with suspected mycotic sinusitis will undergo a detailed series of examinations. These include an ear, nose, and throat (ENT) assessment with questionnaires and endoscopic examination, a CT scan of the paranasal sinuses to evaluate sinus conditions and anatomical features, and functional endonasal endoscopic surgery (FESS) to clean the affected sinus and collect samples. Collected samples will be analyzed through histological, culture, and elemental examinations to identify fungal involvement. During the study, participants will have multiple assessments including clinical history, symptom questionnaires, nasal endoscopy, CT imaging, and surgery if needed. Samples taken during surgery will be examined for fungal presence and tissue changes. The study will follow participants for up to three years, monitoring CT scan changes, clinical symptoms, and laboratory results to better understand diagnostic signs of mycotic sinusitis. This comprehensive approach aims to improve detection and characterization of this condition.