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Study of Intravenous Fosfomycin, Tazobactam Sodium, and Ertapenem Sodium for Hospitalized Patients with Complicated Urinary Tract Infections

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of complicated urinary tract infections in hospitalized patients. These infections are caused by bacteria known as Third-generation cephalosporin-resistant Enterobacterales, which are resistant to some common antibiotics. The study will use a medication called Fosfomycin, which is given through an intravenous (IV) line, meaning it is administered directly into the bloodstream. The purpose of the study is to compare the effectiveness of IV Fosfomycin with the best available therapy currently used in medical practice.

Participants in the study will receive treatment for up to 14 days. The study will monitor the clinical response, which means checking if the infection is cured both clinically and microbiologically, 5 to 7 days after the treatment ends. This is known as the test of cure. The study will also look at other outcomes, such as the rate of clinical cure in different groups of patients, the eradication of bacteria, and any side effects related to the treatment. Additionally, the study will track hospital readmissions, any relapses or reinfections, and other health-related events up to 90 days after treatment begins.

The study aims to provide valuable information on whether IV Fosfomycin is as effective as other treatments for these complicated infections. This could help improve treatment options for patients with these challenging infections in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participation begins with an initial assessment to confirm eligibility. This includes verifying the presence of complicated urinary tract infections (cUTI) with specific bacterial growth in urine.
Step 2
Treatment administration
The treatment involves the administration of intravenous fosfomycin. This medication is given through a vein to treat the infection.
The dosage and frequency of administration are determined by the healthcare provider based on the specific needs and condition of the patient.
Step 3
Monitoring and evaluation
Throughout the treatment, regular monitoring is conducted to assess the response to the medication. This includes clinical evaluations and laboratory tests.
An evaluation occurs 48 hours after the first drug administration to check the initial response to the treatment.
Step 4
Test of cure
Five to seven days after completing the treatment, a test of cure (TOC) is performed. This involves checking for clinical and microbiological cure to ensure the infection has been effectively treated.
Step 5
Follow-up period
After the test of cure, follow-up continues to monitor for any potential relapse or reinfection. This includes checking for any new symptoms or complications.
The follow-up period extends up to 30 days to observe for any adverse effects or additional health concerns related to the treatment.
Step 6
Extended observation
Observation continues until day 90 to track any hospital readmissions or extended hospital stays. This helps in understanding the long-term effectiveness and safety of the treatment.

Who can join the trial?

4 criteria

Must be an adult with a **complicated urinary tract infection (cUTI)**. This means having symptoms like pain or burning when urinating, along with a positive urine test showing bacteria that are not easily treated with common antibiotics but can be treated with **fosfomycin**.
Must have a urine test showing at least 100,000 bacteria per milliliter.
Both **men and women** can participate.
Participants should not be part of a vulnerable population, meaning they should be able to make decisions for themselves.

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Verified sites

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Verified
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
Verified
Azienda Ospedaliera di Padova
Padua, Italy
Responsive
Universita Degli Studi Di Roma La Sapienza
Rome, Italy

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Investigated drugs

Fosfomycin
This medication is given through an IV (intravenous) line to treat complicated urinary tract infections. It works by killing bacteria or stopping their growth, helping to clear the infection. It is being tested to see if it is as effective as other treatments for infections caused by bacteria that are resistant to certain antibiotics.
Best Available Therapy
This refers to the standard treatment options currently used in clinical practice for complicated urinary tract infections. The specific medications used can vary depending on the patient's condition and the bacteria causing the infection. The trial aims to compare the effectiveness of fosfomycin with these standard treatments.

What is already known about the treatment

Fosfomycin – Fosfomycin is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating complicated urinary tract infections, particularly those caused by bacteria resistant to third-generation cephalosporins. It is recognized in medical literature as a promising alternative to existing therapies for these infections. The main therapeutic indication for fosfomycin is its use in treating urinary tract infections. At the molecular level, fosfomycin works by inhibiting bacterial cell wall synthesis, which ultimately leads to the death of the bacteria. It is classified pharmacologically as an antibiotic.

Investigated diseases

Urinary Tract Infections – These infections occur when bacteria enter the urinary tract, which includes the kidneys, bladder, ureters, and urethra. They are more common in women than men and can cause symptoms such as a strong urge to urinate, a burning sensation during urination, and cloudy or strong-smelling urine. If the infection spreads to the kidneys, it can cause back pain, fever, and nausea. Urinary tract infections can be acute, occurring suddenly, or chronic, with symptoms that persist over time. They often result from bacteria like Escherichia coli, which normally live in the intestines. The progression of the infection can vary, with some cases resolving quickly and others requiring more extended care.