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A multi-center, randomized, open-labe, noninferiority trial to evaluate the efficacy and safety of a single, oral dose of Zoliflodacin compared to a combination of a single intramuscular dose of Ceftriaxone and a single oral dose of Azithromycin in the treatment of patients with uncomplicated gonorrhoea.

To assess the efficacy of a single, oral, 3 grams (g) dose of zoliflodacin compared to a combination of a singleintramuscular (IM) 500 milligram (mg) dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment ofuncomplicated…

Effect of intranasal administration of palivizumab on experimental respiratory syncytial viral infection * a human challenge study

Study A: Validation of productive infection of RSV CHIM Study B: Effectiveness and immunogenicity of local administration of palivizumab on prevention of experimental RSV infection

A phase 2, double blind, randomized, placebo controlled clinical trial to investigate the safety and effects of oral vitamin K2 supplementation in COVID-19.

Primary objectives: - To evaluate the effect of oral vitamin K2 supplementation on extrahepatic vitamin K status, as measured by circulating dp-ucMGP, during COVID-19 requiring hospital admission- To evaluate the effect of oral vitamin K2…

Treatment of chemo-refractory viral infections after allogeneic
stem cell transplantation with multispecific T cells against CMV, EBV and
AdV: A phase III, prospective, multicentre clinical trial

This study has been transitioned to CTIS with ID 2024-512321-84-00 check the CTIS register for the current data. Primary objectives:Evaluation of efficacy of multispecific T-cell transfer in patients with chemo-refractory viral infections after…

An open-label randomized controlled experimental endotoxemia study on the effects of the cytokine-adsorbing hemofilter CytoSorb on the development of immunoparalysis in humans

To determine the effects of the CytoSorb hemoperfusion column on the development of immunoparalysis in a repeated human endotoxemia model, which is reflected by attenuated plasma cytokine levels during the second LPS challenge.

A randomized, double-blinded, placebo-controlled, dose-escalation phase 1 clinical trial to evaluate the safety and immunogenicity of recombinant HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted in healthy, HIV-uninfected adults

The primary objective of this study is to evaluate the safety and tolerability of the HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 vaccine, adjuvanted with AS01B, in HIV-uninfected adults. The secondary objective is to assess the frequency and…

BCG vaccination to Reduce the impact of COVID-19 in healthcare workers (BRACE) Trial

Primary objectives1. To determine if BCG vaccination (Intervention) compared with placebo (Comparator) reduces the incidence of COVID-19 disease (Outcome) measured over the 6 months following randomisation (Time) in healthcare workers exposed to…

Lanadelumab for treatment of COVID-19 disease

The objectives of this study:• To generate the proof of concept for lanadelumab for treatment of symptoms of COVID-19 disease • To demonstrate its safety after intravenous administration.

A pragmatic adaptive, randomized, controlled phase II/III multicenter study of IFX-1 in patients with severe COVID-19 pneumonia

Primary Objectives:- Phase II: To explore the effect of IFX-1 on COVID-19 related severe pneumonia (hypothesis generating)- Phase III: To demonstrate the efficacy of IFX-1 to improve of symptoms and outcome of severe COVID-19 pneumonia (confirmative…

Pharmacokinetic evaluation and local tolerability of dry powder amikacin via the Cyclops® in patients with drug susceptible tuberculosis

The first main objective is to investigate the pharmacokinetic properties of dry powder amikacin at different dosages and compare the peak serum values to a single i.v. dose. The secondary main objective is to assess the local tolerability of dry…

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)…

Protecting late-moderate preterm infants from respiratory tract infections and wheeze in their first yearsof life by using bacterial lysates.

This study has been transitioned to CTIS with ID 2024-518498-32-01 check the CTIS register for the current data. The project*s overarching aim is to diminish respiratory disease burden in moderate-late preterm born infants in their first year of…

A multicenter, prospective, randomized, placebo-controlled, double-blind, parallel-group clinical trial to assess the efficacy and safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in patients with Post-Polio Syndrome

To test whether monthly infusions (every four weeks) of intravenous Flebogamma® 5% DIF in a 1 year treatment period in PPS subjects are superior to placebo by assessing physical performance, as measured by 2MWD.For Stage 1, to select the optimal…

Very short-course versus standard course antibiotic therapy in patients with acute ChOlangitis after
adequate endoscopic BiliaRy drAinage (COBRA trial).

The primary objective is to investigate if a very short-course of antibiotics for cholangitis after adequate drainage is non-inferior with respect to clinical cure in comparison with a standard course of antibiotics.

Prophylactic tributyrin supplementation in acute pancreatitis

The main objective is to investigate the effect of oral tributyrin on plasma endotoxin in patients with acute pancreatitis.

The effect of postoperative glucose control with a basal bolus versus a sliding scale insulin regimen on the incidence of surgical site infections in people with type 2 diabetes mellitus: A multicentre, matched-pair, cluster-randomised controlled trial

The aim is to reduce SSI in PWT2D by implementing a proactive basal-bolus insulin regimen, compared to a widely used reactive sliding scale regimen. It is hypothesised that a proactive basal-bolus insulin regimen targeting glucose levels of 3.9-10…

Fluid management and individualized resuscitation in sepsis

The primary objective of this study is to evaluate the personalized hemodynamic resuscitation protocol, guided by the Baxter Starling, for sepsis patients within the first six hours after admission to the emergency department, in comparison to the…

Presepsin to safely reduce antibiotics in preterm infants (PRESAFE trial): a randomized controlled trial with concurrent observational cohort

To investigate whether addition of a presepsin-guided step to the Dutch EOS guideline safely reduces unnecessary empirical antibiotic exposure directly after birth in preterm infants born <32 weeks gestation at moderate risk of EOS. Secondly…

RUTI-FREEDOM: Recurrent Urinary Tract Infections in Females Receiving Effective Education, Digital Outreach & Management - a multicenter prospective randomized controlled trial in the Netherlands

A pilot study on digital coaching in rUTI at the Urology Department of Isala tested an app-based treatment additional to standard care.[8] The app provides information on rUTI aetiology, lifestyle recommendations, treatments, and the value of…

REPLACE: The impact of catheter replacement in patients with catheter-associated urinary tract infection

The REPLACE study aims to determine whether not changing the catheter (catheter retained) for catheter-associated urinary tract infections (CAUTI)affects the recurrence-risk of CAUTI.