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Last Updated: 03/06/2025
A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine, and Fluconazole on the Pharmacokinetics and Safety of EDP-323 in Healthy Participants
Summary: The primary aim of the study is to assess the effect of itraconazole, carbamazepine, quinidine, and fluconazole individually on the pharmacokinetics and safety of EDP-323 in healthy adult participants. Each participant's duration in the study will be dependent upon which study part they are enrolled.
An Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and/or Invasive Candidiasis
Summary: The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida. The study is seeking patients who have a diagnosis of candidemia and/or invasive candidiasis. Two-thirds of all patients w...
A Multicenter, Randomized, Double-blind, Positive-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of WXSH0102 Tablets in the Treatment of Vulvovaginal Candidiasis (VVC)
Summary: This study is a multicenter, randomized, double-blind, active-controlled, dose-ranging clinical trial designed to evaluate the efficacy and safety of the investigational drug compared to the active comparator in the treatment of vulvovaginal candidiasis. The trial consists of three phases: screening/enrollment (D-3 to D-1), treatment period (D1 to D3), and follow-up period (D4, D11±2, D25±3). Elig...
A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study)
Summary: The 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.
Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (allo-HSC) At High Risk of Invasive Fungal Infection (IFI): POSALLO Study
Summary: Patients receiving an allogeneic hematopoietic stem cell transplant (allo-CSH) are at high risk of infection, particularly of fungal origin. Until the 2018 recommendations of the 6th European Conference on Infections in Leukemia (ECIL6), primary prophylaxis of invasive fungal infections (IFI), in allograft patients, was based on the administration of fluconazole until D100. Due to changes in trans...
IMPACT - the Introduction of Mycotic Prophylaxis At Cystectomy Trial. Perioperative Mycotic Prophylaxis to Reduce Postoperative Complications Following Cystectomy - a Double-blinded, Placebo-controlled, Randomized Trial
Summary: This study aims to introduce a perioperative antifungal prophylaxis for patients undergoing cystectomy: surgically removal of the urinary bladder with construction of a urinary diversion. We wish to investigate the effect of antifungal prophylaxis on complications after the operation.
REINFORCE - Reducing Infection-related Readmissions Following Cystectomy. a Multicentre Randomised Clinical Trial Testing Superiority of Individualised Targeted Antibiotic Prophylaxis Over Empiric Prophylaxis At Ureteral Stent Removal to Reduce Infection-related Readmissions Following Cystectomy.
Summary: The aim of this trial is to test whether postoperative antibiotics targeted towards bacteria in the urine can reduce the risk of infection after surgical removal of the bladder (cystectomy) compared to a standardised antibiotic prophylaxis. Participants undergoing cystectomy will be randomly assigned to postoperatively receive (A) a standardised orally administered antibiotic prophylaxis currently...
Community-based Communication Interventions for Increasing Repeat Donation Among First- Time Blood Donors in Ghana: A Pragmatic Type 1 Effectiveness- Implementation Hybrid Trial
Summary: A randomized controlled trial to evaluate the effectiveness of the WhatsApp groups or docudrama compared to a control group (usual engagement with blood services) on repeat blood donation attempts among first-time blood donors in Ghana. Secondary outcomes will be blood donor retention, blood donation knowledge, attitudes, beliefs, motivations, intention to donate, and relatedness as potential medi...
A Prospective, Randomized, Placebo-controlled Trial of Fluconazole in Combination With IL-23 Therapy Versus IL-23 Therapy Alone for the Treatment of Crohn's Disease
Summary: The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to start or are currently undergoing standard of care treatment and plan to dose-escalate an IL-23 therapy for their Crohn's disease. The main question it aims to assess is whether or not patient response to IL-23 therapies improve when simultaneously treated with fluconazole.
A Master Protocol for Biomarker-Based Treatment of AML (The Beat AML Trial)
Summary: This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study Master Protocol (BAML-16-001-M1). The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultima...
Evaluation of the Effect of the Implementation of a Candida PCR Diagnosis Strategy on the Time Required to Obtain Results in Patients From Intensive Care Units With Suspected Systemic Invasive Candidiasis: Pilot Study
Summary: The aim of this study is to evaluate the implementation of a new technique for invasive candidiasis diagnosis by PCR. The main objective will be to evaluate the effect of this strategy on the time required to obtain results in patients from intensive care units with suspected systemic invasive candidiasis. This PCR method could allow an antifungal switch to be made earlier, limiting the appearance...
Endothelial Derived Hyperpolarization Factor and Regulation of Cerebral and Muscle Blood Flow
Summary: Most cardiometabolic diseases are characterized by increased muscle sympathetic nerve activity (MSNA) during rest and exercise which contributes to poor health outcomes. In healthy humans during muscle contraction, there is a blunting of skeletal muscle vascular responsiveness to increases in MSNA. However, the exact mechanisms involved are unknown although, best evidence suggests that the mechani...
Last Updated: 03/06/2025