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A randomised, double-blind, placebo-controlled, single-centre phase IIb trial as part of the EU-funded UNISEC project to assess the immunogenicity and safety of different formulations and dosing regimens of FLU-v vaccine administered subcutaneously in healthy adults aged 18-60 years.

To investigate the safety of the vaccination and the immune responses generated by the different formulations and dosing regimens of FLU-v in healthy adults.

Fluids in mechanically ventilated children with acute infectious lung disease: how dry should they be?

This research project aims to determine the feasibility of setting up a randomized controlled trial to study the effects of different fluid management protocols on the outcome of mechanically ventilated pediatric patients with acute infectious lung…

The effects of acetylsalicylic acid on immunoparalysis following human endotoxemia

Primary objective:­To determine whether endotoxin tolerance can be prevented by acetylsalicylic acid prophylaxis or can be reversed by acetylsalicylic acid treatment, expressed as an augmentation of pro-inflammatory cytokine levels during the second…

A Nutritional intervention study to evaluate the effect Of Bovine Lactoferrin on innate immunity in Elderly people

Aim of the current study is to evaluate the effect of lactoferrin on the innate immune response in elderly in a pilot study. Furthermore, support of this effect by GOS and Vitamin D will be studied.

Clinical, microbiological, radiographical and heamatological evaluation of implant surface decontamination using air polishing in the non- surgical treatment of peri-implantitis; a randomized controlled study

The primary objective of this randomized controlled trial is to compare the clinical effect of decontamination of the implant surface during the non-surgical treatment of peri-implantitis using air polishing or ultrasonic treatment. Secondary…

A prospective randomized controlled trial to investigate the effect of early administration of antibiotics for patients with suspected sepsis

Primary Objectives: To evaluate whether early, pre-hospital administration of antibiotics reduces 28-day mortality in patients referred to the ED with suspected severe sepsis or septic shock.Secondary Objective(s): 1. To compare whether there is a…

Follow-up of the immune response ten years after intradermal or subcutaneous yellow fever vaccination

To investigate the long term (ten years) protective immune response to fractional yellow fever vaccination (1/5th of the standard dose, injected intradermally), compared to the standard subcutaneous vaccination

A Phase 2b, Randomized, Controlled Trial Evaluating GS 5806 in Lung Transplant (LT) Recipients with Respiratory Syncytial Virus (RSV) Infection

The primary objective of this study is as follows:* To evaluate the effect of presatovir (GS-5806) on nasal RSV viral load in RSV positive LT recipients with acute respiratory symptomsThe secondary objectives of this study are as follows: * To…

Long-term StaphyloCoccus aureus decolonizAtion in patients on home parentRal nutRition: a randomized multicEnter tRial.

To identify the most effective and safe long-term S. aureus carriage decolonization strategy in HPN patients. Ultimately this willlead to less antimicrobial resistance, less catheter removals and lower mortality rates. Also, other chronic…

Safety and protective efficacy of chemoprophylaxis and sporozoite immunization with Plasmodium falciparum NF135 against homologous and heterologous challenge infection in healthy volunteers in the Netherlands

Primary Objective: To determine the safety and tolerability of NF135.C10 sporozoite immunization under chemoprophylaxisSecondary Objectives:• To determine the dose-dependent protective efficacy of NF135.C10 CPS-immunization against homologous…

Can Mild Induced Hypothermia reduce mortality in septic shock patients at the Intensive Care Unit?
A randomized, single-blinded, multicenter study. The cooling and surviving septic shock study

To investigate whether cooling to 33 °C for 24 hours in septic shock reduces mortality in intensive care patients.

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled
Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults with Respiratory Syncytial Virus (RSV) Infection

The primary objective of this study is to evaluate the effects ofpresatovir (GS-5806) on RSV viral load in RSV-positive adults hospitalizedwith acute respiratory infectious symptoms.The secondary objectives of this study are to evaluate:- The effect…

The effect of Body temperature regulation on host response in patients with Septic shock
(A sub-study of the CASS study)

Primary: To determine the effects of MIH on circulatory, inflammatory and metabolic aspects of host response to sepsis.Secondary: To determine if MIH prevents and/or decreases the severity of ICU-AW in septic shock.

Human Exposure to RhinOvirus * Effect of a plant-based polysaccharide food supplement on upper respiratory symptoms

This study is designed to test if consumption of a vegetable extract as a food ingredient improves resistance to an experimental respiratory tract infection with RV16 in healthy volunteers.Primary Objective: * To test and quantify the effect of the…

A Phase 1 randomized, double-blind study to investigate the single and multiple dose safety, tolerability and pharmacokinetics of WCK 4282 (FEP-TAZ) upon intravenous administrations in healthy volunteers

Part 1To evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple intravenous doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) and FEP-TAZ 3 g (2 g cefepime + 1 g tazobactam) administered every 8 hours (q8h) in healthy adult…

A Kaletra ONCE daily Randomised Trial of the
pharmacokinetics, safety and efficacy of twice-daily
versus once-daily lopinavir/ritonavir tablets dosed by
weight as part of combination antiretroviral therapy in
HIV-1 infected children (PENTA 18).

Evaluating the current dosing guidelines in children taking the half-strength paediatric tablets will provide reassurance that the recommended lopinavir/ritonavir dose provides adequate drug exposure and maintains efficacy.This trial will evaluate…

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single-Dose Escalation Study Followed by a Multiple-Dose Escalation Study and an Open-Label Relative Bioavailability and Food Effect Study of VX-787 in Healthy Subjects

Primary: Part A:to evaluate the safety and tolerability of single oral ascending doses of VX-787 administered to healthy male and female subjects (of non-childbearing potential)Part C:to evaluate safety and tolerability of multiple oral ascending…

Stop Antibiotics on Procalcitonin guidance Study

The purpose of this trial is to evaluate whether procalcitonin measurements are able to reduce antibiotic usage in Dutch intensive care units by reducing the duration of antibiotic treatment.

A Phase III Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered with an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral Therapy-Experienced Adults.

Primary: Antiviral efficacy after 48 weeks of treatment. Secundary: Antiviral efficacy after 24 weeks, safety and tolerability, resistance development, PK, incidence of HIV-associated conditions, gender-, race-, and/or HIV-1 subtype on response to…

Transluminal Endoscopic step-up approach versus miNimally invasive SurgIcal step-up apprOach in patients with infected pancreatic Necrosis: TENSION, a randomized controlled parallel-group superiority multicenter trial. Dutch Pancreatitis Study Group.

To determine the effectiveness and, subsequently, the cost-effectiveness of a endoscopic transluminal step-up approach (ETD & ETN) versus a surgical step-up approach (PCD & VARD ,if not possible laparotomy) to improve clinical…