Study Comparing Oral Fluoroquinolones or Trimethoprim-Sulfamethoxazole to IV Therapy in Stable Patients with Gram-Negative Blood Infections

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What is this study about?

This clinical trial is focused on patients with Gram-negative bacteremia, a type of blood infection caused by certain bacteria. The study is comparing two treatment approaches for these infections. One group of patients will continue receiving antibiotics through an intravenous (IV) line, which is a method of delivering medication directly into the bloodstream. The other group will switch to taking antibiotics orally, which means by mouth, once they are stable. The antibiotics being studied include fluoroquinolones and a combination of trimethoprim-sulfamethoxazole. These medications are commonly used to treat bacterial infections.

The purpose of the study is to determine if switching to oral antibiotics is as effective as continuing with IV antibiotics in terms of patient survival within 30 days. Participants in the study will be randomly assigned to one of the two treatment groups. The study will monitor patients for 90 days to observe their recovery, any side effects, and the overall effectiveness of the treatment. The study aims to provide insights into whether an early switch to oral antibiotics can be a safe and effective option for treating Gram-negative bacteremia.

Throughout the study, researchers will collect data on various outcomes, such as the number of days patients spend in the hospital, any complications related to the treatment, and the overall cost of care. This information will help determine the best approach for managing these infections and could potentially lead to changes in how they are treated in the future. The study is expected to conclude by March 2026.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of being placed in either group.

2 initial treatment phase

If you are in the group continuing with intravenous (IV) therapy, you will receive antibiotics through a vein. The specific antibiotics used may include levofloxacin, trimethoprim, fosfomycin, or amikacin. The dosage and frequency will be determined by your healthcare provider.

If you are in the group switching to oral therapy, you will take antibiotics by mouth. The medications may include ofloxacin hydrochloride or a combination of bromhexine hydrochloride, sulfamethoxazole, and trimethoprim. Your healthcare provider will specify the dosage and frequency.

3 monitoring and follow-up

Throughout the study, your health will be closely monitored. This includes regular check-ups and tests to assess your response to the treatment.

You will be observed for any side effects or complications, such as C. difficile-associated diarrhea or issues with the IV line if applicable.

4 evaluation of outcomes

The main goal is to compare the effectiveness of the two treatment approaches in terms of 30-day all-cause mortality, which means the rate of death from any cause within 30 days.

Secondary outcomes include survival rates at 14 and 90 days, the number of days on IV therapy, and any adverse events experienced.

5 completion of the study

The study will conclude after 90 days from the time of randomization. Your participation will help determine if switching to oral antibiotics is as effective as continuing IV therapy for treating blood infections caused by Gram-negative bacteria.

Who Can Join the Study?

At least one set of blood cultures must be positive for Gram-negative bacteria and show evidence of infection. (Blood cultures are tests to find bacteria in the blood. Gram-negative bacteria are a type of bacteria that can cause infections.)
Must be able to be randomly assigned to a treatment group within 72 hours of the first blood culture collection.
Must be at least 18 years old. (In Singapore, the minimum age is 21 years.)
The latest Pitt bacteraemia score must be less than 4. (The Pitt bacteraemia score is a tool used to measure the severity of a blood infection.)
The patient or their legal representative must be able to provide informed consent. (Informed consent means understanding the study and agreeing to participate.)

Who Cannot Join the Study?

Patients who are not within the specified age range for the study.
Patients who are not able to take oral medications.
Patients who have allergies to fluoroquinolones or trimethoprim-sulfamethoxazole. These are types of antibiotics used to treat infections.
Patients who have a history of severe reactions to any antibiotics.
Patients with certain medical conditions that the study doctors believe would make participation unsafe.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of non-compliance with medical treatments. This means not following the doctor’s instructions for taking medications or attending appointments.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
General University Hospital Of Patras	Patras	Greece
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Ajlmxlk Uzqey Spdatxkht Lwykzo Dd Bentadl	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	01.04.2025
Italy	Not recruiting	01.04.2025
Spain	Not recruiting	01.04.2025

Trial locations

Investigated drugs:

Fluoroquinolones are a group of antibiotics that are used to treat a variety of bacterial infections. In this trial, they are being tested to see if switching to them early, in pill form, is as effective as continuing with antibiotics given through a vein for treating uncomplicated Gram-negative bacteraemia. These antibiotics work by killing the bacteria causing the infection, helping the body to recover.

Trimethoprim-sulfamethoxazole is another type of antibiotic used in this trial. It is a combination of two medications that work together to stop the growth of bacteria. The trial is testing whether switching to this medication in pill form early on is as effective as continuing with intravenous antibiotics for treating uncomplicated Gram-negative bacteraemia. This combination is often used to treat different types of infections caused by bacteria.

Gram-negative bacteraemia – Gram-negative bacteraemia is a condition where bacteria from the Gram-negative group enter the bloodstream. These bacteria have a unique cell wall structure that makes them resistant to certain antibiotics. The condition can start with an infection in another part of the body, such as the urinary tract or lungs, and then spread to the blood. As the bacteria multiply in the bloodstream, they can release toxins that trigger an inflammatory response. This response can lead to symptoms like fever, chills, and low blood pressure. If not managed, the infection can affect multiple organs and systems in the body.

Trial ID:

2024-517308-13-00

Protocol code:

DSRB 2021/00764

NCT ID:

NCT05199324

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Oral Fluoroquinolones or Trimethoprim-Sulfamethoxazole to IV Therapy in Stable Patients with Gram-Negative Blood Infections

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?