Evaluation of Oral Fosfomycin-Tromethamol for Acute Multidrug-Resistant Escherichia coli Bacterial Prostatitis Treatment in a Phase IV Clinical Trial

The primary objective of this clinical trial is to evaluate the **efficacy** of oral **fosfomycin-tromethamol** in treating acute bacterial prostatitis caused by multidrug-resistant **Escherichia coli**. This is a Phase IV, prospective, interventional study that aims to compare the treatment outcomes of fosfomycin-tromethamol with those of a control group receiving approved therapeutic alternatives for sensitive **E. coli** bacterial prostatitis. The clinical relevance of this study lies in its potential to establish fosfomycin as a viable oral alternative therapy for a condition that is increasingly complicated by antibiotic resistance, thereby addressing a significant therapeutic gap in the management of acute bacterial prostatitis.

The clinical trial involves a study population consisting exclusively of **male** participants aged 18 years and older. The participants are diagnosed with **acute bacterial prostatitis** caused by multidrug-resistant Escherichia coli. The trial does not include a vulnerable population. Participants were selected based on positive urine or blood cultures for E. coli, with cases being sensitive to fosfomycin. The control group consists of males with E. coli sensitive to all or all but one family of antibiotics. The sponsor has not provided the total number of participants involved in the study. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

This clinical trial is a **Phase IV**, prospective, interventional study designed to evaluate the efficacy of **oral fosfomycin-tromethamol** in treating acute bacterial prostatitis caused by multidrug-resistant **Escherichia coli**. The trial employs a randomized, controlled design with a prospective control group receiving approved therapeutic alternatives for sensitive E. coli infections. The study is expected to run from October 2021 to December 2026, with participant involvement lasting up to three months, depending on individual treatment response and adherence to protocol.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (18 years or older) and a positive urine or blood culture for E. coli. Following the screening, eligible participants will be randomized into either the treatment or control group. The treatment group will receive oral fosfomycin-tromethamol, while the control group will receive standard care. Study visits will include regular follow-up assessments to monitor clinical stability and treatment efficacy, with the primary endpoint being the determination of the efficacy of sequential oral fosfomycin-tromethamol therapy in patients who have received prior parenteral antimicrobial therapy.

The end-of-study visit will occur after the completion of the treatment period, where final assessments will be conducted to evaluate the overall treatment outcomes. Participants may be withdrawn from the study early if they experience significant adverse effects, fail to adhere to the study protocol, or if the investigator deems it necessary for their safety. The trial aims to provide valuable insights into the use of fosfomycin as an alternative oral therapy for challenging cases of acute bacterial prostatitis.

The clinical trial involves the use of **Fosfomycin**, an experimental medication, as an oral solution. The active substance, **fosfomycin**, is of chemical origin and is administered orally. The maximum daily dose is 3 grams, with a total maximum dose of 63 grams over a treatment period of 3 days. The medication is classified as an antibiotic and is not a pediatric formulation. The trial aims to evaluate the efficacy of oral **fosfomycin-tromethamol** in treating acute bacterial prostatitis caused by multidrug-resistant **Escherichia coli**.

In addition to the experimental treatment, the study includes a comparator group receiving standard-of-care therapy for sensitive **Escherichia coli** bacterial prostatitis. This group is treated with approved therapeutic alternatives, serving as a control to assess the efficacy of the experimental treatment. The trial is designed as a Phase IV, prospective, interventional study, focusing on demonstrating the effectiveness of the experimental medication compared to existing treatment options.

The efficacy of the clinical trial will be assessed by determining the effectiveness of oral **fosfomycin-tromethamol** in treating acute bacterial prostatitis caused by multidrug-resistant Escherichia coli. The primary endpoint involves evaluating the efficacy of sequential treatment with oral fosfomycin-tromethamol in patients with acute bacterial prostatitis who are clinically stable and have received between 1 to 5 days of prior parenteral antibiotic therapy with an antimicrobial agent that shows in vitro activity. The trial is designed as a Phase IV, prospective, interventional study, comparing the treatment outcomes with a control group receiving approved therapeutic alternatives for sensitive E. coli bacterial prostatitis. The study will focus on patients with positive urine or blood cultures for multidrug-resistant E. coli that are sensitive to fosfomycin. The trial aims to provide evidence on the potential of fosfomycin as an oral alternative therapy in this specific patient population.