Uppsala University Hospital
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Uppsala, Sweden
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A Study of Ciprofloxacin and Vancomycin Effects in Patients Carrying Antibiotic-Resistant Bacteria (ESBL and VRE)
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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.
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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Region Gaevleborg
Verified siteGavle, Sweden
Trial locations
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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.
What is already known about the treatment
CIPROFLOXACIN
This medication is taken by mouth as a tablet, usually 1000 mg per dose, and belongs to the fluoroquinolone class of antibiotics. It is an approved drug that is widely used and described in medical literature for treating common bacterial infections such as urinary‑tract, respiratory, and gastrointestinal infections. It works by blocking an enzyme called DNA gyrase, which bacteria need to copy their DNA and grow. As a broad‑spectrum antibiotic, it is used to fight many types of bacteria that cause infection.
VANCOMYCIN
This drug is taken orally, often as a capsule or liquid, typically 500 mg per dose, and is classified as a glycopeptide antibiotic. It is an established medication with a long history in medical use, especially for serious infections caused by Gram‑positive bacteria and for certain gut infections like Clostridioides difficile. Its action comes from attaching to the building blocks of the bacterial cell wall, preventing the wall from forming correctly and causing the bacteria to die. Vancomycin is a key treatment option for infections that are resistant to many other antibiotics.
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 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517434-17-01Estimated enrolment60 patientsSponsorRegion Uppsala
sourced from the EU Clinical Trials Register and site verification
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