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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 trial about?

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

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

8 criteria

  • 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.
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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.

What is already known about the treatment

  • Fluoroquinolones

    Fluoroquinolones are a type of antibiotic that can be taken orally in pill form. They are currently used in medicine to treat various bacterial infections, including those caused by Gram-negative bacteria. The main therapeutic use of fluoroquinolones is to treat infections like Gram-negative bacteraemia. At the molecular level, they work by interfering with the bacteria's DNA replication process, effectively stopping the bacteria from multiplying. Fluoroquinolones are classified as broad-spectrum antibiotics, meaning they can target a wide range of bacteria.

  • Trimethoprim-sulfamethoxazole

    Trimethoprim-sulfamethoxazole is an antibiotic combination that is administered orally in tablet form. It is widely used in medical practice to treat different types of bacterial infections, including those caused by Gram-negative bacteria. The primary therapeutic indication for this medication is to treat infections such as Gram-negative bacteraemia. On a molecular level, it works by inhibiting the production of folic acid in bacteria, which is essential for their growth and reproduction. This medication is classified as a combination antibiotic, as it uses two different drugs to enhance its effectiveness against bacteria.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517308-13-00Protocol codeDSRB 2021/00764Estimated enrolment730 patientsSponsorTan Tock Seng Hospital Pte. Ltd.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).