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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)…

Systemic antibiotic therapy (amoxicillin plus metronidazole) as an adjunct to surgical treatment of peri-implantitis; a single blind randomized controlled study

The primary objective of this controlled clinical trial is to evaluate the clinical effect of systemic amoxicillin plusmetronidazole therapy in conjunction with surgical treatment of peri-implantitis. The secondary objective is toassess the…

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…

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 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.

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…

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…

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.

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…

Effect of donor human milk on severe infections and mortality in VLBW infants, a double blind randomized controlled trial

To determine whether (supplemental) human donor milk has beneficial effects (in terms of reduction of infectious episodes and mortality) when compared to (supplemental) preterm formula during the first 10 days of life in VLBW infants. Amendement ESS…

Clinical and microbiological evaluation of different implant surface decontaminating procedures in the surgical treatment of peri-implantitis; a randomized controlled study

The primary objective of this controlled clinical study is to evaluate the clinical effect of decontamination of the implant surfaceduring the surgical treatment of peri-implantitis using a 35% phosphoric acid gel or saline.The secondary objective…

Local gentamicin in Redon treated post-sternotomy mediastinitis

The aim of our study is to evaluate clinical outcomes of patients primarily closed over Redon catheters for the treatment of PSM, comparing the application of local gentamicin with a control group.

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…

Immunogenicity of alternative and reduced immunization schedules using the thirteen-valent polysaccharide conjugate vaccine against infection with Streptococcus pneumoniae

To assess the effect of alternative and reduced doses pneumococcal vaccination schedules using the 13-valent pneumococcal conjugate vaccine (PCV13, Wyeth) on the development of antibody titers directed against the different serotypes of pneumococci…

Pancreatitis, verY earlY compared wiTH delayed start Of eNteral feeding (PYTHON) trial: a randomised controlled multicenter trial.

To investigate whether a very early start of EN (< 24 hrs after admission), as compared to selective delayed EN (> 72 hrs), will lead to a lower rate of infectious complications and mortality in patients with predicted severe AP.

The effects of bilirubin infusion on the innate immune response during human endotoxemia.;A parallel open label placebo controlled pilot study.

Primary objective: To determine the effect of hyperbilirubinemia on systemic activation of the innate immune response induced by a lipopolysaccharide (LPS) challenge. Secondary Objective(s): - To determine if hyperbilirubinemia shifts the pro-anti…

high immune responses after the 5th acellulair pertussis vaccination administered to 4 year old Dutch children and its relation with adverse reactions after the booster

The elucidation of T-cell immune responses as well as IgE and IgG subclass antibody responses in children reporting severe local side effects after the fifth ACV vaccination as a component of the DTP-IPV combination vaccine. These responses will be…

Development of humoral and cellular immune response in infants after pneumococcal conjugate vaccinations with Synflorix® or Prevenar-13®

Primary: To compare immunogenicity (humoral and cellular) induced by PCV10 and PCV13 after the booster dose of a complete vaccination series (3+1, the current NIP schedule) Secondary: To compare immunogenicity (humoral) induced by PCV10 and PCV13 at…

Systemic antibiotic therapy (amoxicillin plus metronidazole) as an adjunct to initial non-surgical treatment of peri-implantitis; a single blind randomized controlled study

The primary objective of this controlled clinical trial is to evaluate the clinical effect of systemic amoxicillin plus metronidazole therapy in conjunction with initial non-surgical treatment of peri-implantitis. The secondary objective is to…