Clinical Research Directory

FOsfomycin for Male Urinary Tract Infection

Male urinary tract infections (MUTI) are often less recognised compared to those in women. French clinical guidelines practices recommend the use of antibiotics called fluoroquinolones, which are highly effective in treating MUTIs. However, these antibiotics can lead to rare but serious side effects, such as tendonitis or heart rhythm disturbances. Additionally, fluoroquinolones can contribute to the development of bacterial resistance, making their use inadvisable within six months of treatment. In response to these concerns, we aim to explore a well-established alternative, fosfomycin trometamol (known by the brand name MONURIL®). This antibiotic has a strong track record in treating UTIs in women, with well-documented benefits and minimal associated risks. The primary goal of this study is to assess the effectiveness of fosfomycin trometamol in treating urinary tract infections in men, as well as to evaluate any potential treatment failures.

Hospital at Home for Elderly Acute Ill Patients

Many elderly patients with uncomplicated treatment courses are admitted unnecessarily, which is a burden for the patient and society. Studies show that Hospital at Home (HaH) treatment is an alternative to hospitalization. The patient's risk of delirium, infection and loss of function is reduced when the patient avoids the hospital stay. HaH treatment is expected to be more cost-effective, improve patients' functional abilities and patients' satisfaction. Three municipalities, general practitioners, pre-hospital service and an emergency department (ED) in Central Denmark Region have organized the first HaH treatment model across disciplines and sectors. Specialists in the ED and the municipal acute teams provide HaH treatment for elderly acute ill patients. However, the model has not yet been evaluated. The aim of this study is to optimize the HaH treatment model for elderly acute ill patients. The objective is to increase patient satisfaction and optimize the use of resources in healthcare by avoiding unnecessary hospitalizations that impair and prolong treatment. This study is an open label randomized controlled trial (RCT) with a 1:2 allocation ratio of acute hospital admission versus HaH. During a pilot period, we tested and adapted the patient pathway of HaH to the practical reality, before we start the randomization for the RCT study. We will investigate the clinical effects and health economic consequences of HaH treatment compared with standard hospital treatment.

Study to Evaluate the Efficacy and Safety of XC243 in Patients With Exacerbation of Chronic Cystitis

Multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of XC243 in patients with exacerbation of chronic cystitis. It is planned to include patients with chronic cystitis in 4 parallel groups, who will receive XC243 at a dose of 25 mg per day, 50 mg per day, 75 mg per day or placebo for 7-10 days. Efficacy will be assessed by time from first study treatment to resolution of the symptom "Pain, discomfort or burning when urination " assessed on a visual-analog scale (VAS).