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An open-label single-arm Phase IIb study of F901318 as treatment of invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi in patients lacking suitable alternative treatment options.

Primary:• Describe the Data Review Committee (DRC)-adjudicated efficacy of F901318 as treatment for infections due to resistant fungi in patients lacking suitable alternative treatment options.Secondary:• Describe the safety of F901318 as treatment…

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)

The primary objectives are:* United States Food and Drug Administration (FDA) primary objectiveTo demonstrate noninferiority in subjects who received an allogeneic BMT for subjects randomized to Rezafungin for Injection compared to subjects…

Safety and Efficacy of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Candidemia

This study has been transitioned to CTIS with ID 2024-510816-55-00 check the CTIS register for the current data. The primary objective of the study is to evaluate the efficacy and safety and rIFN-γ as adjunctive treatment in combination with…

Azole-echinocandin combination therapy for invasive aspergillosis. A randomized pragmatic superiority trial (IA-DUET)

Primary objective 1. Evaluate if the survival in patients with a triazole susceptible IA can be improved when the initial therapy consists of triazole and echinocandin combination therapy instead of triazole monotherapy. (This objective is captured…

Pharmacokinetics of fluconazole given orally or intravenously as prophylaxis or therapy to children and adolescents with invasive fungal infections

This study has been transitioned to CTIS with ID 2024-518305-17-01 check the CTIS register for the current data. Primary objective:• To establish an improved fluconazole dosing regimen for paediatric and adolescent patients aged 2-18 years.…

Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection

- In silico definition of the most optimal posaconazole dose for children and adolescents with CF aged 8 to 17 years.- Assess the prevalence of Aspergillus infection in children and adolescents with CF aged 8 -17 years.- An intensive sampling…

A Phase III, adjudicator-blinded, randomised study to evaluate the efficacy and safety of treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with invasive fungal disease (IFD) caused by Aspergillus species

This study has been transitioned to CTIS with ID 2024-513030-38-00 check the CTIS register for the current data. To compare ACM at Day 42 following treatment with olorofim versus treatment with AmBisome® followed by SOC in the intent-to-treat (ITT)…

Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 in Patients with Fungal Diseases that are Refractory to or Intolerant of Standard Antifungal Treatment (FURI)

Primary Objectives* To evaluate the efficacy of SCY-078 as determined by a Data Monitoring Committee(DMC) by assessing global success (composite assessment of clinical and mycologicalsuccess) at EoT* To evaluate the safety of SCY-078

AN OPEN-LABEL, SINGLE-DOSE, SINGLE-PERIOD STUDY DESIGNED TO ASSESS THE MASS BALANCE RECOVERY, METABOLITE PROFILE AND METABOLITE IDENTIFICATION OF [14C]-OLOROFIM ADMINISTERED VIA THE ORAL ROUTE TO HEALTHY MALE SUBJECTS.

The purpose of this study is to investigate how quickly and to what extent olorofim is absorbed and eliminated from the body. Olorofim will be labelled with 14 Carbon (14C) and is thus radioactive. In this way olorofim can be traced in blood, urine…

Management of the combination of tacrolimus with azoles: effect of tacrolimus formulation on drug-drug interaction magnitude

To assess whether IR-Tac and ER-Tac exhibit a different magnitude of drug-drug interaction after co-administration with voriconazole

Liposomal amphotericin B (Ambisome) pharmacokinetics given as a single intravenous dose to obese patients (ASPEN).

The overall aim is develop a rational dosing regimen of liposomal amphotericin B in obese patients. To achieve this goal we have defined the following objectives: Primary objective:* To determine the pharmacokinetics of liposomal amphotericin B…

Fluconazole pharmacokinetics, including bioavailability, in Obese subjects after an Intravenous and oral Administration (FOLIA).

Primary objective: To determine the effect of obesity (BMI *35 kg/m2) on the pharmacokinetics, including oral bioavailability of fluconazole.Secondary objective: To develop an optimal dosing regimen for obese patients.

Pharmacokinetics of posaconazole given as a single intravenous dose to obese subjects: Dosing Obese with Noxafil® Under a Trial (DONUT).

Primary objective:To determine the effect of obesity (BMI > 35 kg/m2) on the pharmacokinetics of posaconazole and develop a dosing regimen for obese patients. Secondary objective:• To describe the pharmacokinetics of the augmented dose of 400…

A Phase 1, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses Oral Doses of APX001, to Investigate the Effect of Food on APX001 and to Investigate the Drug-Drug Interaction Potential of APX001

The study will be performed in 3 parts, Parts 1, 2 and 3. In all parts, the purpose is to investigate to what extent APX001 is tolerated. In addition, it will be investigated how quickly and to what extent APX001 is absorbed and eliminated from the…