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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.

Prediction of Flucloxacillin Absorption and %time/MIC using the Flucloxacillin absorption test

: Our aim is to evaluate whether the current flucloxacillin absorption test is able to adequately predict the absorption of flucloxacillin compared to an absorption test after switch to oral therapy, and identify co-variants in order to improve the…

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.

Antibiotic exposure at the infection site in periprosthetic joint infections

To develop a pharmacokinetic (PK) model for the relationship between dosage, blood concentration and infection site concentration, estimating covariates to determine differences in antibiotic concentrations in synovial fluid, synovial tissue and…

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…

Treatment of Skin Severity in Ichthyosis with Hyperbaric Oxygen Therapy

To assess clinical improvement of skin severity in patients with ichthyosis

The long-term clinical outcomes and radiological sequelae of acute septic arthritis in children.

To assess the long-term clinical outcomes using Patient-reported Outcome Measures (PROMS), physical examination and radiological sequelae of acute septic arthritis in children.

A Pilot, Multicenter, Randomized, Non Comparative, Double-Blind Study of Phage Therapy in Patients with Hip or Knee Prosthetic Joint Infection due to Staphylococcus aureus Treated with DAIR and Antibiotic Therapy

Considering the paucity and the variability of data regarding the clinical control of infection in patients presenting a prosthesis Joint Infection (PJI) later than 1 month after the arthroplasty and treated with DAIR + suppressive antibiotics…

A randomized, placebo-controlled study to evaluate the effects of intravenous sevuparin on dermal and systemic LPS responses and the interaction between subcutaneous enoxaparin and sevuparin on coagulation responses in healthy volunteers.

Part 1:• To evaluate the effect of IV sevuparin on inflammatory responses following an intradermal (ID) LPS challenge.Part 2:• To evaluate the effect of IV sevuparin on safety and tolerability and inflammatory responses following an intravenous (IV…

'A clinical study of the difference in the effect of pocket-irrigation in the treatment of peri-implantitis compared to a conventional therapy, the airflow: a randomized controlled trial'

The aim of this study is to assess the effectivity of the Fluxion, in combination with Bluem (Bluem, Bluem Europe, Zwolle, The Netherlands) and in combination with demineralised water. This aims to find a minimally invasive treatment for peri-…

Pharmacokinetic and pharmacodynamic target attainment of cefuroxime in adult patients on general wards with different degrees of renal function: a prospective observational cohort study

To investigate whether the PK-PD target of cefuroxime (50%T>MIC) is attained in the first 24 hours of treatment in adult patients on general wards with adequate and impaired renal function receiving regular and reduced doses of cefuroxime.

Vaccine immunogenicity in Dutch frail versus non-frail older individuals

The primary objective is to compare antibody responses against the pneumococcal vaccine strains and Influenza virus vaccine types in blood and saliva of older individuals with respect to frailty, taking sex differences into account. The overall aim…

Short-course aminoglycosides as adjunctive treatment in adults with sepsis

The objective of the proposed study is to determine the effectiveness, safety and cost-effectiveness of a strategy of cefuroxime combined with short course treatment with aminoglycosides compared to a strategy of ceftriaxone monotherapy in patients…

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of REC-3964 in Healthy Subjects

REC-3964 is a new investigational drug, meaning that it has not yet been approved or marketed in the Netherlands or anywhere else at this time.In this study, REC-3964 is investigated in humans for the first time. REC-3964 has not been used by humans…

*Primary and booster meningococcal vaccination in Dutch elderly: study to investigate the immune response and determine functional antibodies after the tetravalent MenACWY-TT conjugate vaccine in the elderly population*

This study has been transitioned to CTIS with ID 2024-513640-29-00 check the CTIS register for the current data. The aim of this study is to investigate the immune response to a primary and a booster immunization with a tetravalent MenACWY-TT…

Antibiotics vs antibiotics and Surgical ThERapy for Infective endocarditis

To test whether valve surgery plus medical therapy is superior to medical therapy alone for treatment of endocarditis.

Clinical and microbiological effect of submucosal irrigation with the Pocketirrigator for treatment of peri-implantitis

The aim of the present cohort study is to test the efficacy of pocket irrigation with a new pocket irrigation device for non-surgical treatment of peri-implantitis.

A randomized, single-blind, placebo-controlled study to evaluate an oral cholera vaccination with intranasal rechallenge as adaptive immune challenge model

• To characterize the systemic response to mucosal immunization with an oral cholera vaccination challenge.• To characterize the local response to intranasal rechallenge after cholera vaccination as outcome measure for nasal mucosal immunity.• To…

Amoxicillin-clavulanic acid Levels in Sputum After Nebulization in AECOPD (ALSAN)

In this study we want to show adequate sputum levels are obtained throughout the day after inhalation of nebulized amoxicillin clavulanic acid in hospitalized AECOPD patients.

Study into the effect of CytoSorb (cytokine adsorber) in relation to the MICrocirculation of patients with Septic Shock and Acute Kidney Injury at the ICU; MICSS-AKI

Could cytokines removal therapy by CytoSorb adsorber cause any improvement in the microcirculation?