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A Study of Ciprofloxacin and Vancomycin Effects in Patients Carrying Antibiotic-Resistant Bacteria (ESBL and VRE)

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on people who carry antibiotic-resistant bacteria called VRE (Vancomycin-Resistant Enterococci) and ESBL (Extended-Spectrum Beta-Lactamase) producing bacteria in their digestive system. These bacteria are resistant to common antibiotics, which means they are harder to treat if they cause an infection. The study aims to understand how antibiotic treatment affects these bacteria and other normal bacteria living in the gut.

The study will use two different antibiotics: ciprofloxacin and vancomycin. These medications will be given as tablets that participants take by mouth. The treatment will last for 5 days, during which participants will receive specific doses of the antibiotics. Ciprofloxacin may be given up to 1000 mg per day, while vancomycin may be given up to 500 mg per day.

During the study, researchers will collect stool samples to check for the presence of resistant bacteria and examine changes in the gut bacteria population. This will help understand how antibiotic treatment influences both harmful resistant bacteria and beneficial bacteria that normally live in the digestive system. The study will track these changes over time to see how long it takes for the gut bacteria to return to their normal state after antibiotic treatment.

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

    Initial participation phase

    After confirming participation, you will be identified as a carrier of antibiotic-resistant bacteria based on previous test results.

    Your current negative screening status for these bacteria will be verified before proceeding.

  2. Step 2

    Medication phase - first round

    You will receive one of two oral antibiotics: either ciprofloxacin or vancomycin.

    The medication will be taken by mouth according to the prescribed schedule.

    During this phase, your body's response to the antibiotics will be monitored.

  3. Step 3

    Sample collection phase

    Stool samples will be collected to check for the presence of resistant bacteria.

    The composition of your intestinal bacteria will be analyzed using laboratory tests.

  4. Step 4

    Monitoring phase

    Your bacterial status will be monitored to observe any changes from negative to positive.

    The diversity and composition of your intestinal bacteria will be compared to the initial state.

    The time required for your bacterial status to return to normal will be tracked.

  5. Step 5

    Study completion

    The study will continue until all necessary observations are completed.

    Your participation will end once your bacterial status stabilizes or the study reaches its conclusion.

    The entire study is scheduled to run until September 2026.

Who can join the trial?

7 criteria

  • Must be at least 18 years old
  • Must provide signed informed consent to participate in the study
  • Must have a confirmed presence of VRE (Vancomycin-resistant Enterococci) or EPE (Extended-spectrum beta-lactamase producing Enterobacteriaceae) in previous screening or clinical culture
  • Must have a negative result in the most recent screening for VRE/EPE
  • For participants who carry EPE bacteria, the bacterial strain must be resistant to ciprofloxacin (an antibiotic)
  • Women who can become pregnant must use adequate contraception methods as recommended by the Clinical Trials Facilitation Group (CTFG)
  • Both men and women can participate in the study

Who cannot join the trial?

12 criteria

  • Known allergy or hypersensitivity to any of the study medications
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the past 30 days
  • History of severe kidney disease (as antibiotics may affect kidney function)
  • Current use of medications that could interact with the study antibiotics
  • Active infection requiring immediate antibiotic treatment
  • Inability to follow study procedures or attend follow-up visits
  • History of colonization (presence of bacteria without causing illness) with bacteria other than VRE (Vancomycin-resistant Enterococci) or ESBL (Extended-spectrum beta-lactamase producing bacteria)
  • Severe liver disease that could affect medication processing
  • Recent major surgery within the past 3 months
  • Compromised immune system due to disease or medication
  • Mental conditions that could affect the ability to provide informed consent
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Investigated drugs

Antibiotics are medications used to treat bacterial infections. In this trial, researchers are studying how antibiotic treatment affects normal bacteria in the body and specifically looking at how these medications impact people who carry certain resistant bacteria. The antibiotics used will interact with both beneficial gut bacteria and potentially harmful resistant bacteria. ESBL refers to bacteria that produce Extended-Spectrum Beta-Lactamases, making them resistant to many common antibiotics. While this is not a medication, it's important to understand that the trial monitors how these bacteria respond to antibiotic treatment. VRE stands for Vancomycin-Resistant Enterococci, which are bacteria resistant to the antibiotic vancomycin. While not a medication itself, the trial studies how these resistant bacteria react when exposed to antibiotic treatment. Note: The specific antibiotics used in this trial are not listed in the source data, but the study focuses on their effects on resistant bacteria.

What is already known about the treatment

Since no specific medications are listed in the provided trial data, I cannot create medication descriptions in the requested format. The trial appears to be studying the effects of antibiotics on bacterial flora and resistance genes in patients carrying ESBL (Extended Spectrum Beta-Lactamase) and VRE (Vancomycin-Resistant Enterococci), but the specific antibiotics used in the trial are not mentioned in the source data. If you could provide the specific antibiotics used in this trial, I would be happy to create descriptions following your requested format: Medication Name – description format.

Investigated diseases

  • VRE Carriage

    A condition where vancomycin-resistant enterococci bacteria colonize the digestive tract, particularly the intestines, without causing immediate illness. The bacteria can live in the gut for extended periods, making the person a carrier. This state typically doesn't cause symptoms but means the bacteria are present in the intestinal system.

  • ESBL Carriage

    A condition where bacteria producing extended-spectrum beta-lactamase enzymes colonize the intestinal tract. These bacteria can live in the gut without causing immediate symptoms. The carrier state occurs when these resistant bacteria become established in the intestinal flora. The bacteria can persist in the digestive system for varying periods.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517434-17-01Estimated enrolment60 patientsSponsorRegion Uppsala

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