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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Azienda Sanitaria Regionale del Molise (ASREM)	Campobasso	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Atgyokm Uohyb Smslijisd Ladppg Dq Bypsswx	Bologna	Italy
Umpodonxun Ddoxt Ssewl Dr Rofm Lz Skacpyxu	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	14.12.2023

Trial locations

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.

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.

Trial ID:

2024-516591-15-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

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