Anti-fungal Strategies in Acute-on-Chronic Liver Failure Patients
Antifungal AgentsInvasive Fungal Infections2 moreEarly treatment of invasive fungal infections (IFI) may prevent undue mortality in acute on chronic liver failure (ACLF) patients. We aim to study the impact of early empiric treatment (based on clinical suspicion) of IFI as compared to pre-emptive treatment (based on biomarkers and culture positivity) on the outcomes in ACLF patients with suspected IFI in a randomized trial. The ACLF patients with clinically suspected IFI would be randomly allocated to empiric treatment or pre-emptive treatment group and followed up clinically to assess the impact on survival, clinical outcomes and cost-effectiveness and safety of such an approach. The protocol is designed to cut- down unnecessary usage and to curtail the duration of antifungals use in ICUs based on biomarkers/culture-driven stoppage rules. The results will fuel further studies on formal cost-effective analysis and antimicrobial stewardship protocols in ACLF patients.
Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous...
Invasive Fungal DiseaseThis study is a post-approval commitment study, and is designed to further evaluate the safety and efficacy of isavuconazole in a relatively larger Chinese population who will receive isavuconazole treatment in a post-marketing setting. This is a single arm, prospective, multi-center study. This study is seeking Chinese patients with proven, probable or possible Invasive Fungal Disease (IFD) caused by Aspergillus species or other filamentous fungi. All the participants will receive isavuconazole treatment. The longest treatment duration in this study is 84 days (up to 180 days for participants diagnosed with IM). The primary objective is to characterize the safety and tolerability of isavuconazole through observing the treatment emergent adverse events.
Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants
PosaconazolePharmacokinetics5 moreThe purpose of the study is to investigate the pharmacokinetics of oral dosage of Posaconazole which is routinely administered as a standard care prophylaxis for patients undergoing cancer treatments.
Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection...
Invasive Fungal InfectionThis study aims to estimate the pharmacokinetics (PK) of posaconazole (POS, MK-5592) intravenous (IV) and powder for oral suspension (PFS) formulations in pediatric participants <2 years of age with invasive fungal infection (IFI).
A Study to Assess the Safety, Tolerability and Pharmacokinetics of BSG005.
Invasive Fungal InfectionsA Phase 1, double-blinded, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of BSG005 following single and multiple ascending doses in healthy subjects. The study will include a single ascending dose part and a multiple ascending dose part
Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options
Invasive Fungal InfectionsA study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.
Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal...
CandidemiaMycoses8 moreThe purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the prevention of invasive fungal diseases when compared to the standard antimicrobial regimen.
De-escalation - Antifungal Treatment Immunocompromised Patients
Invasive Fungal DiseaseCritical IllnessA small proportion of intensive care unit patients receiving antifungals have a proven invasive fungal infection. However, antifungal treatment has side effects such as toxicity, emergence of resistance, and high cost. Moreover, empirical antifungal treatment is still a matter for debate in these patients. Our study aimed to determine the incidence, associated factors, and safety of de-escalation of antifungals in immunocompromised critically ill patients. This prospective observational study is conducted in 14 ICU, during a 6 months period. All immunocompromised patients hospitalized for >5d and treated with antifungals for suspected or proven invasive candida infection will be included De-escalation is defined as a reduction in antifungal spectrum or stopping initial drugs within the 5 days following their initiation. The three antifungals considered in this study are from the narrowest to the widest spectrum: fluconazole, caspofungin and liposomal amphotericin B.
Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age
Invasive Fungal InfectionsThis study will assess the pharmacokinetics (PK), safety, and tolerability of a single intravenous (IV) dose of rezafungin in paediatric subjects from birth to <18 years who are receiving concomitant systemic antifungals as clinically indicated.
LFD of Aspergillus Antigen in Paediatrics
Invasive Pulmonary AspergillosisInvasive Fungal DiseaseMany children and young people are at risk of invasive fungal disease (IFD), such as those who have had a haematopoietic stem cell transplants, those with an immune deficiency or those who are prescribed immunosuppressive drugs, for example, corticosteroids. One type of mould that causes invasive fungal disease is called Aspergillus. There is currently no quick test which can tell us if someone has an invasive fungal disease caused by Aspergillus called Aspergillosis. It is a difficult condition to diagnose and the results from the tests that are involved take days or weeks to come back. These tests including a few different blood tests, a scan of the lungs (CT scans) and taking fluid from inside the lungs/airway. A new test for Aspergillosis is the lateral flow device (LFD) assay. This is a rapid test which gives a result within minutes. It involves testing a sample of the fluid from the lungs/airway. This fluid can be obtained as part of the routine investigations for Aspergillosis. It has been shown to be a good and safe test in adults but the investigators do not know if it will be a valuable test in children and young people yet. The purpose of this study is to determine whether the LFD test can effectively diagnose Aspergillosis in children and young people.