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Clinical validation of a dried blood spot (DBS) method for the analysis of immunosuppressive and antifungal drugs in pediatric patients (part of the PROTECT study).

PrimairyTo clinically validate a finger prick DBS method compared to conventional venous sampling for the analysis of 5 immunosuppressive and 4 azole antifungal drugs in the pediatric population. Secondairy• Feasibility of the novel finger prick DBS…

Pharmacologic optimization of voriconazole; a prospective cluster randomized controlled trial of therapeutic drug monitoring

The objective of this study proposal is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (TDM) results in improved patient outcomes (efficacy and safety) and is more cost-effective compared to…

Bioavailability of voriconazole in critically ill patients

The objective of this study is to obtain the absolute bioavailability of voriconazole in critically ill ICU patients.

the Application of an Electronic Nose in the Early detection of Aspergillosis II

1. To establish whether serial exhaled breath analysis using eNose can detect invasive pulmonary aspergillosis in patients with prolonged chemotherapy induced neutropenia (neutrophil counts <0.5 x 10^9 for more than 7 days).2. To establish…

the Application of an Electronic Nose in the Early detection of ASpergillosis

to establish the accuracy with which the eNose can discriminate patients with invasive pulmonary aspergillosis from controls

A phase-I, double-blind, randomized study on the tolerability and early efficacy of hLF1-11 in hospitalized patients with proven candidaemia.

To establish the safety, tolerability, and early efficacy of multiple doses of hLF1-11 given once daily for 14 days.

Pharmacokinetic Evaluation of POSaconazole boosted Fosamprenavir (EPOS)

Primary: To determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteersSecondary: To determine the safety of combined use of fosamprenavir with posaconazole in healthy vol-unteers

Pharmacokinetics of posaconazole (Noxafil(R)) as prophylaxis for invasive fungal disease

• To determine the pharmacokinetics of posaconazole (new solid oral and IV) given as prophylaxis to patients who are at risk for developing fungal infections after receiving conditioning therapy (except strictly non myeloablative (NMA)) for…

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…

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)…

Influenza-associated pulmonary aspergillosis (IAPA) in ICU patients with severe influenza: incidence and host- and pathogen related risk factors

A prospective multi-center observational study to assess the incidence of influenza-associated pulmonary aspergillosis (IAPA) in ICU patients and to identify host- and pathogen related risk factors for IAPA in EORTC negative ICU patients with severe…

A randomized controled trial: the effect of a medical grade honey formulation (L-Mesitran®) on clinical symptoms of recurrent vulvovaginal candidiasis

The primary objective is to investigate the vaginal culture (positive or negative) after the application of a Medical Grade Honey formulation (L-Mesitran ®) in relation to the current standard of care (Fluconazole) 1 month after starting treatment…

Immunological Defects in Chronic Pulmonary Aspergillosis

In this study, we aim to characterize the immunological defect in patients with CPA as compared to patients with chronic obstructive pulmonary disease (COPD) without CPA on a functional, genetic, transcriptional and metabolic level.

A phase IV, interventional, non-blinded, randomized, controlled, multicenter study of posaconazole prophylaxis for the prevention of influenza-associated aspergillosis (IAA) in critically ill patients

To deliver proof of concept that antifungal prophylaxis with posaconazole in addition to standard of care (SOC) can reduce the incidence of IAA in ICU patients with severe influenza, in comparison with SOC alone.To assess differences in cytokine…