Aspergillosis

This prospective, multicenter, observational cohort study focuses on patients with allergic bronchopulmonary aspergillosis. The aim is to evaluate the efficacy and safety of biological agents used in these patients across multiple participating centers. The study observes how biological agents perform in the treatment of allergic bronchopulmonary aspergillosis while also assessing their safety.

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 clinical study is investigating the use of patient-specific 3D-printed titanium implants for reconstructing facial defects and improving facial appearance. It includes adults with congenital, traumatic, or post-surgical facial deformities that require reconstructive surgery. The aim is to evaluate the safety, effectiveness, and functional and aesthetic outcomes of these customized implants compared to traditional methods. Participants will undergo detailed preoperative assessments including clinical exams and high-resolution CT scans. Customized implants are designed using computer-aided design CAD and produced with selective laser melting 3D printing technology from medical-grade titanium. Surgical placement follows standard maxillofacial protocols with fixation to bone as needed. Follow-up includes clinical and radiological exams for up to 12 months after surgery. Throughout the study, participants will have assessments to monitor implant fit, stability, complications, facial symmetry, and patient satisfaction. Outcome measures include postoperative complication rates over six months, implant geometric accuracy immediately after printing, and aesthetic improvement scores at three months. Patient satisfaction and total surgery time are also recorded to evaluate the overall success and safety of this reconstructive approach.

The study investigates fungal pneumonia, a serious lung infection caused by fungi, which is often hard to diagnose early due to vague symptoms and complex testing. Researchers aim to develop and validate a clinical prediction score called FUNGAL-P to help identify fungal pneumonia or fungal-bacterial coinfections in adult patients presenting with pneumonia. This observational study is conducted at a single center and includes both retrospective and prospective patient groups. The study has two main phases. The retrospective phase reviews adult patients diagnosed with pneumonia between January 2022 and December 2023 who underwent microbiological testing within 48 hours of hospital admission. The prospective phase enrolls consecutive adult patients with pneumonia from January to December 2024 to evaluate the FUNGAL-P score without affecting their clinical care. Data collected include clinical signs, laboratory and radiological findings, microbiology results, treatment details, and outcomes. Participants provide information on their medical history, vital signs, and undergo routine microbiological assessments. Researchers analyze these data to find factors that predict fungal pneumonia, combining them into the FUNGAL-P score. They will measure how well the score identifies fungal pneumonia using statistics like sensitivity, specificity, and calibration. The primary outcome is the scores accuracy assessed by the area under the receiver operating characteristic curve AUROC. The study aims to improve early detection and guide timely treatment for fungal pneumonia.