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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 Phase 3, Open-label Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine in Recipients of Allogeneic Hematopoietic Stem Cell Transplant Aged 2 Years and Older

Primary Objective: *To evaluate the immune responses 1 month after 3 doses of 13vPnC as measured by fold rises of serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in subjects *2 years of age. Secondary Objectives: *To…

An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension

The primary objective of this study is to assess the comparative safety and efficacy ofAztreonam Lysine for Inhalation (AZLI) and Tobramycin Nebuliser Solution (TNS) in adultand pediatric cystic fibrosis (CF) patients aged 6 years or older with…

Preventive Antibiotics in Stroke Study

To investigate whether preventive use of the antibiotic ceftriaxone improves functional health outcomes in patients with stroke by preventing infection. This will be done in a large multi-centre randomized controlled trial. Within this trial we will…

Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given x 10 days With Omeprazole in Eradication of Helicobacter pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given x 7 days

The goal of this trial is to confirm that eradication rates obtained with Pylera are compatible to those obtained with the current European gols standard, OAC 7 days. This trial will constitute a pivotal trial leading eventually to approval of…

PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke. A randomised, open, phase III, clinical trial with blinded outcome assessment

Primary objectiveTo assess whether prevention of aspiration, infections, and fever with metoclopramide, ceftriaxone, paracetamol, or any combination of these in the first 4 days after stroke onset improves functional outcome at 90 days in elderly…

A PHASE 3, MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, IMMUNOGENICITY, AND LOT CONSISTENCY OF A 6-VALENT OspA-BASED LYME DISEASE VACCINE IN HEALTHY
PARTICIPANTS >=5 YEARS OF AGE

This study has been transitioned to CTIS with ID 2023-509105-72-00 check the CTIS register for the current data. * To demonstrate the efficacy of VLA15 in preventing confirmed Lyme disease in the Lyme disease season after completion of the primary…

Oral Fosfomycin versus Ciprofloxacin for Febrile Urinary Tract Infection in Men: a pilot study

To determine the efficacy of oral fosfomycin in comparison to the standard of care oral ciprofloxacin, in the treatment of FUTI after initial empirical treatment with intravenous antibiotics.To describe the pharmokinetic profile of men treated with…

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…

Pentoxifylline dose optimization in preterm neonatal sepsis

The main objective is to determine in what optimal dose PTX should be used in preterm infants suffering from sepsis. Previous clinical studies have already indicated the safety of the drug in preterm infants.