Clinical Research Directory

Human Bioequivalence Study of Liposomal Amphotericin B for Injection

A single-center, randomized, open-label, single-dose, two-period, double-crossover study to evaluate the bioequivalence of liposomal amphotericin B for injection (test product) manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd. compared to the reference product (AmBisome®) in healthy Chinese subjects. Secondary objectives include safety evaluation.

Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

This trial will demonstrate localised uptake of a radiolabelled fungal component (siderophore) in areas of known specific invasive fungal (Aspergillus) infection.

Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative

The study aims to evaluate incidence of invasive antifungal infections among patients with acute lymphoblastic leukemia Ph negative during the first weeks of treatment

Hyperbaric Oxygen Therapy Used on Severely Injured Healthy Individuals With Fungal Infections

The goal of this observational study is to learn about the effects of Hyperbaric Oxygen Therapy on healthy individual who suffer from invasive fungal infection caused by severe trauma, who do not respond to conventional treatment. The main question it aims to answer is: Does the treatment aid in eradicating the infection and improve the overall outcome of such patients?

L-AmB_ Retrospective mUlticenter Study on Mycosis prOphylaxis

Invasive fungal disease (IFD) still represents an important cause of morbidity and mortality in immunocompromised patients, particularly in patients undergoing antineoplastic chemotherapy or allogeneic hemopoietic stem cell transplantation (allo-HSCT). International guidelines recommend primary antifungal prophylaxis to reduce mortality and morbidity in these patients. Liposomal amphotericin B (L-AmB) can represent a valid alternative for antifungal prophylaxis in pediatric age as its spectrum is extended to both molds and yeasts, has reduced pharmacological interactions with the antineoplastic drugs most frequently used in treatment protocols. All this despite the availability of an intravenous formulation which can ensure complete compliance with the treatment. L-AmB prophylaxis has been proposed with different dosages: 1 mg/kg every other day vs 2.5 mg/kg/dose twice-a-week vs 5 mg/kg/once-a-week)

Breath Analysis for the Detection of Invasive Fungal Infections

Patients with leukemia and concomitant neutropenia are at high risk of developing invasive fungal infections (IFI) that are associated with high morbidity and mortality. As these patients typically have severe thrombocytopenia, direct diagnostic sampling with invasive procedures is often not possible due to the high peri-interventional risk. Therefore, the presumptive diagnosis of IFI is primarily based on compatible lung findings on computed tomography and serologic detection of fungal cell wall components, which, however, have limited sensitivity and specificity. With the present study, the investigators aim to determine a set of specific volatile biomarkers in leukemia patients with proven or probable IFI using secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS).

Population Pharmacokinetics of L-AmB in Chinese Patients Assisted by Extracorporeal Membrane Pulmonary Oxygenation (ECMO)

The goal of this study is to investigate the effects of ECMO-assisted therapy on L-AmB PK parameters in patients with critically ill patients of invasive fungal infections, and to determine the in vivo pharmacokinetic changes of L-AmB in the ECMO population. To establish and validate a population pharmacokinetic model for liposomal amphotericin B in patients with critically ill patients of invasive fungal infections treated with ECMO adjuvant therapy, and to explore the pharmacokinetics/pharmacodynamics of the drug with different dosing regimens.

Usefulness of PET-CT for Invasive Fungal Infection

The goal of this national multicenter prospective cohort study is to learn about the added value of 18F-FDG (18F-2-fluoro-2-deoxy-D-glucose) PET-CT in invasive fungal disease management. The main questions it aims to answer are: 1. Does the use of 18F-FDG PET-CT allow a better characterization of invasive fungal infection (IFI) (performance) compared to the exclusive use of conventional radiological studies in terms of extension/staging and monitoring of response/follow-up ? 2. Does the systematic and protocolized use of 18F-FDG PET-CT in IFI allow a better management of patients with IFI and increase the prognostic value of the initial evaluation? Participants will undergo systematically a 18F-FDG PET-CT as part of the work-up of their invasive fungal disease. Researchers will compare the performance of 18F-FDG PET-CT with standard management without 18F-FDG PET-CT to see if adds value (diagnostic, prognostic, and changes in management).

Retrospective Study of Invasive Fungal Infections With Filamentous Fungi in Heart Transplant Patients

Invasive filamentous fungal infections (aspergillosis, scedosporiosis, mucormycosis, fusarium wilt) are common and serious in immunocompromised subjects and particularly organ transplant patients. There is little recent data in heart transplantation, particularly on the incidence and risk factors of fungal infections. . It is therefore important to have recent data on incidence, risk and prognostic factors in order to improve the management of this severe complication.

Survey on the Current Status of IFD Diagnosis and Treatment by Intensive Care Physicians in Sichuan Province (IFS)

The goal of this survey is to learn about the current status of the diagnosis and treatment of invasive fungal infections among intensive care physicians in Sichuan Province (IFS). Its primary focus lies on answering the following questions: ①awareness and proficiency in diagnosis and treatment; ②the use of antifungal medications; ③the application of microbiological identification and diagnostic methods. We aim to analyze the problems and deficiencies that existed among intensive care physicians in order to provide a basis for the development of targeted training and intervention measures.

PATH Study: People With Injecting Related Infections: Assessing Treatment Outcomes for Those Who Are Hospitalised.

We seek to characterise the burden and outcomes of and understand the current experience of people who inject drugs admitted to hospital with invasive injecting-related infections, in order to implement and evaluate strategies to improve completion of therapy and reduce patient-directed discharges, with ultimate benefit to the patient and health service.

Fungal Surveillance in Bangladesh

This will be an exploratory descriptive study designed to conduct surveillance for the identification of invasive fungal pathogens among hospitalized patients in Bangladesh at two tertiary care acute-level hospitals. including the Dhaka Medical College Hospital, the Dhaka Hospital of icddr,b, and the National Institute of Cancer Research Hospital (NICRH). Respiratory samples, blood, urine, cerebrospinal fluid, surgical wound infection swabs, and other samples including biopsy tissue specimens will be obtained at intensive care units, general medicine and surgery wards, post-operative care, etc. The collected specimens will be sent to the clinical microbiology laboratories of the surveillance hospitals or to the pathology laboratory (biopsy tissue specimens) to test for Aspergillus, Histoplasms, Candida, Pneumocystis, Cryptococcus, and Mucormycetes. The lab. methods will include microscopy, staining, culture, and biochemical tests mainly and if feasible then some specimens may undergo molecular or immunological methods.