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A SYNDEMIC BASED LINKAGE TO CARE INTERVENTION FOR HIGH RISK MEN WHO HAVE SEX WITH MEN

Primary objective: Does a personalised behaviour intervention comprising of targeted in depth screening on mental health problems and drug use increase help seeking behaviour among MSM who are at high risk for STIs and HIV. Secondary objectives:…

The added effect of oral ondansetron to care-as-usual on persisting
vomiting in children aged 6 months to 6 years, presenting at primary care
out of hours service with acute gastro-enteritis and concomitant vomiting

The primary objective is to determine the added effect of oral ondansetron to care-as-usual (including ORT) (CAU) on persisting vomiting within the first 4 hours after presentation at an out-of-hours primary care service (OHS) in children aged 6…

Does continuous cefotaxime administration improve time to attainment and maintenance of target drug levels in intensive care patients?

The main objective is to assess target attainment of cefotaxime levels in the critically ill treated with either continuously or intermittently dosed cefotaxime. Secondary objectives are: to develop a predictive mathematical pharmacokinetic (PK)…

The role of the intestinal microbiome in enteric and systemic vaccine immune responses

Primary Objective: to investigate the role of the gut microbiota in RVV immune response Secondary Objectives: To investigate the role of the gut microbiota in tetanus and pneumococcal vaccine immune responses

Maternal pertussis (Tdap) vaccination and its effects on the immune response of the newborn up to 12 months of age.

Primary objective;Confirm superiority of IgG antibody levels against pertussis toxin (Ptx), present in the acellular vaccines, in infants at the age of 3 months of mothers having received a pertussis vaccine during pregnancy versus infants of…

A two-stage, controlled, open-label, dose-ascending first-in-man study to assess the safety, tolerability and immunogenicity of a Twincer®-administered dry powder influenza vaccine

To evaluate the safety, tolerability and immunogenicity of a Twincer®-administered dry powder influenza vaccine in healthy adults.

EARLY ORAL SWITCH THERAPY IN LOW-RISK
STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTION

The hypothesis is that a switch from intravenous to oral antimicrobial therapy is non-inferior to standard intravenous therapy in patients with low-risk SAB. Therefore, the primary objective of the trial is to demonstrate, that oral switch therapy (…

Donor feces infusion for first episode of Clostridium difficile infection in patients at risk for recurrent infection

The primary objective of this study is to investigate whether FMT after antibiotic therapy is more effective than conventionalantibiotic therapy alone in patients with a first episode of CDI.

A Randomized, Open Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment

Primary Objective1. To evaluate the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 compared to a multi-drug…

A randomized controlled multicenter trial of a five day course of oral colistin and neomycin followed by restoration of the gut microbiota using fecal transplantation to eradicate intestinal carriage of extended spectrum beta-lactamase or carbapenemase-producing Enterobacteriaceae in high-risk patients

The purpose of this study is to evaluate the efficacy of two antibiotics ( neomycin sulfate and colistin sulfate), followed by fecal bacteria therapy , to multidrug - resistant bacteria (E - ESBL and EPC) to be eradicated from the intestine.

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…

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

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…

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…

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…

Identification of pre-erythrocytic target antigens induced by Plasmodium falciparum sporozoite immunization under chemoprophylaxis.

Primary objective: To delineate the antibody repertoire directed against the pre-erythrocytic stages of Plasmodium falciparum induced by CPS-immunization.Secondary objectives: • To assess the functionality of CPS-immunization induced antibodies.• To…

POETIC: Point Of carE Testing for urinary tract Infection in primary Care:
Study Stages 3 & 4: Randomised controlled trial and post-RCT observational study

The overall aim of our study is to evaluate the management of suspected uncomplicated UTI in women presenting in primary care through use of a novel point of care test (POCT, Flexicult). This study is being carried out in 4 European networks: Wales…

A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon α-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)

The primary objective of this study is to evaluate the efficacy of TDF plus Peginterferon *-2a (PEG) combination therapy for 48 weeks versus standard of care TDF monotherapy or PEG monotherapy for 48 weeks in non-cirrhotic CHB subjects as determined…