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A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection

The primary objective of this Registry is:• To evaluate HCV viral sequences and the persistence or evolution of treatment emergent viral mutations in subjects who fail to achieve an SVR after treatment with a Gilead oral antiviral containing regimen…

Therapeutic Vaccination against Human Papillomavirus Type 16 for the Treatment of Anal Intraepithelial Neoplasia in HIV+ Men

The objective of the current proposal is to assess, in a phase 1/2 study, the safety and efficacy of this synthetic vaccine SLP-HPV-01® in HIV+ men with CD4 counts > 350 x 10E6/l and intra-anal high-grade, HPV16 positive AIN, who failed on…

Controlled Human Malaria Infection study to assess gametocytaemia and mosquito transmissibility in participants challenged with Plasmodium falciparum by sporozoite challenge to establish a model for the evaluation of transmission-blocking interventions

Primary objectives:1) To evaluate the safety of four different CHMI-trans protocols in healthy malaria-naïve volunteers challenged with Plasmodium falciparum by sporozoite challenge. 2) To determine the best CHMI-trans protocol for induction of…

Pilot study: Fosfomycin levels in prostate tissue after oral and iv administration

To measure intraprostatic concentrations and serum levels of fosfomycine after a single oral or intravenous dose prior to TURP. This is done to achieve more insight in whether fosfomycin is a suitable antibiotic to use as profylaxis or treatment of…

A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects with Chronic Hepatitis B Infection

The primary objective of this Registry is:*To evaluate the long term effects of Hepatitis B Virus (HBV) treatment of the parental study on the HBV serologic changes through Week 144 The secondary objective of this Registry is :*To evaluate the long…

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.

PHARMACOKINETICS AND PHARMACODYNAMICS OF ERTAPENEM IN PATIENTS WITH TUBERCULOSIS

The main objective is to evaluate pharmacokinetics of a maximum standard dose (2000mg) of ertapenem in TB patients.

CRP-POCT in suspected airway infected patients in the long-term care facility

The main objective is to investigate the additional value of CRP-POCT (C-reactive protein point-of-care-test) testing in patients suspected of airway infections in long-term care facilities.

Pharmacokinetic parameters of 960 mg Co-trimoxazole once daily in patients with tuberculosis

Primary Objective: The primary objective of this prospective clinical trial is to determine the pharmacokinetic variability of SXT (960 mg) in patients receiving TB treatment. With these pharmacokinetic parameters, a population model and limited…

Proof of Concept Study of Eurartesim® in Patients with Imported Uncomplicated Plasmodium Vivax Malaria

Primary Objective:• Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 21.Secondary Objectives: • Proportion of aparasitaemic patients (at different visits).• Proportion of afebrile patients (at different visits).• Uncorrected…

Pharmacokinetics and safety of Meropenem in infants below 90 days of age (inclusive) with probable and confirmed meningitis: a European multicenter phase I- II trial

Primairy objectivesTo study the pharmacokinetics (plasma and cerebrospinal fluid) of meropenem in infants <= 90 days of postnatal age with probable or confirmed bacterial meningitis (BM); To describe the safety profile of meropenem in the…

Pharmacokinetic evaluation and tolerability of dry powder tobramycin by a novel device in patients with non cystic fibrosis bronchiectasis

The first objective to investigate is the pharmacokinetics of DP tobramycin using the Cyclops® at four different dosages. The other objective is the local tolerability of DP tobramycin using the Cyclops® at four different dosages.

A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who have Advanced Liver Disease or are Post-Liver Transplant

The primary objectives of this study are:•To explore the antiviral efficacy of combination therapy with SOF/LDV FDC + RBV for12 or 24 weeks in subjects with advanced liver disease (either pre-liver transplant or notcurrently wait-listed) and post-…

Immunogenicity and safety of an adjuvant hepatitis B vaccine (fendrix) compared to Engerix in non-responding HIV-infected patients

To study the immunogenicity and safety of adjuvanrt hepatitis B vaccin (Fendrix) compared to double-dosage of Engerix vaccination in HIV infected patients, previously failing HBV vaccinations.

TREATMENT WITH CMV PP65 SPECIFIC T CELLS GENERATED BY USE OF A CMV PP65 PROTEIN-SPANNING PEPTIDE POOL IN PATIENTS WITH CMV REACTIVATION OR CMV DISEASE AFTER ALLOGENEIC STEM CELL TRANSPLANTATION

• To assess the feasibility, tolerability and safety of administration of donor or patient derived CMV pp65-specific T cells in patients with CMV reactivation or CMV disease after alloSCT.• To determine the presence of CMV specific T cells at…

A Phase 2a, Randomized, Open-Label Study in Patients with Chronic Hepatitis C Viral Infection to Assess the Safety, Tolerability, Pharmacodynamics, and Antiviral Activity of ANA773 Tosylaat Administered with Ribavirin

- to evaluate the safety and tolerability of oral ANA773 tosylate (ANX8414) administered with ribavirin inpatients with chronic hepatitis C viral (HCV) infection· to evaluate the anti-viral and pharmacodynamic effects of ANA773 tosylate (ANX8414)…

ADDED VALUE OF 18FDG-PET-CT IN THE DIAGNOSIS OF INVASIVE FUNGAL INFECTIONS IN NEUTROPENIC PATIENTS

Objective: The primary objective of this pilot study is to compare FDG-PET-CT with HR-CT alone and to HR-CT and galactomannan test together for early diagnosing IFIs in neutropenic patients.

An open, phase II long term extension study to evaluate the immune responses to and safety of GSK Biologicals' candidate herpes zoster vaccine, (gE/AS01B), at Months 48, 60 and 72 post-vaccination in healthy subjects aged 60 years of age and older.

The purpose of this long-term follow-up (LTFU) study (ZOSTER-024) is to evaluate the cell-mediated and humoral immune responses of subjects who previously participated in study ZOSTER-003 and who were in the group receiving 2 doses of 50µg gE/AS01B…

Mesenchymal stromal cell (MSC) transplantation in septic shock.

Evaluation of therapeutic safety and clinical efficacy of MSC transplantation in septic shock.

An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct-Acting Antiviral Agent (DAA) Treatment in Combination with Peginterferon *-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have Experienced Virologic Failure in a Previous AbbVie or Abbott DAA Combination Study

The primary objective of this study is to evaluate the safety and antiviral efficacy, defined as the percentage of subjects with sustained virologic response 12 weeks post-dosing (SVR12; HCV RNA < LLOQ 12 weeks after the last dose of study…