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Study on Ciprofloxacin’s Effect on Antibiotic Resistance in E. coli for Healthy Individuals

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What is this study about?

This clinical trial is focused on studying antimicrobial resistance in a type of bacteria called Escherichia coli, commonly found in the human gut. The study will use a medication called Ciprofloxacin Kabi, which is a solution for infusion, to see if it can cause the bacteria to become resistant to antibiotics. The medication will be transformed into a syrup for oral use by mixing it with a liquid called SyrSpend SF.

The purpose of the study is to understand how low doses of ciprofloxacin might change the bacteria in the gut. Participants will be randomly assigned to receive either the ciprofloxacin syrup or a placebo. The study will monitor changes in the bacteria over a period of time to see if there is any shift in how the bacteria respond to the medication.

Participants will be involved in the study for a maximum of 28 days. During this time, the study will track the concentration of ciprofloxacin in the body and observe any changes in the bacteria. The goal is to gather information on whether the medication can lead to resistance in the bacteria, which is an important concern in treating infections.

1 joining the study

Upon joining the study, you will be asked to provide written informed consent, confirming your understanding and willingness to participate.

You must be at least 18 years old and not taking any immunosuppressive agents. If you are a female of childbearing potential, you will need to practice effective contraception and have a negative pregnancy test at the screening visit.

2 randomization

You will be randomly assigned to either the intervention group or the placebo group. This means you will either receive the medication being tested or a placebo, which is a substance with no active medication.

3 medication administration

If you are in the intervention group, you will receive a low dose of ciprofloxacin, which is an antibiotic. The medication will be administered orally.

The dosage and frequency of administration will be determined by the study protocol, and you will be informed of these details during the trial.

4 monitoring and assessments

Throughout the study, your health and the effects of the medication will be monitored. This includes regular assessments to measure any changes in the Escherichia coli bacteria in your gastrointestinal tract.

You may be required to provide samples, such as fecal samples, at specified time points, including at the start of the study and after 30 days.

5 completion of the study

The study is expected to end by July 30, 2024. Upon completion, you will be informed about the results and any findings related to the study objectives.

Your participation will contribute to understanding whether low dose ciprofloxacin can induce antimicrobial resistance in Escherichia coli.

Who Can Join the Study?

  • Able and willing to provide written informed consent. This means you understand the study and agree to participate.
  • At least 18 years old.
  • Not taking any immunosuppressive agents. These are medications that weaken your immune system.
  • Not clinically immunocompromised at the time of randomization. This means your immune system is not weakened by a medical condition.
  • For females who can have children, willingness to use continuous effective contraception during the study. This includes methods like implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or having a partner who has had a vasectomy.
  • For females who can have children, a negative pregnancy test at the screening visit.

Who Cannot Join the Study?

  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those with certain disabilities who may need special protection.
  • Patients with medical conditions other than antimicrobial resistance in Escherichia coli cannot participate. Antimicrobial resistance means that bacteria like E. coli have become resistant to medicines that usually kill them.
  • Patients who are not willing to follow the study procedures cannot participate.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Institute Of Tropical Medicine Antwerp Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.10.2023

Trial locations

Investigated drugs:

Ciprofloxacin is an antibiotic used to treat various bacterial infections. In this clinical trial, it is being studied to see if it can cause bacteria called Escherichia coli, which live in the human gut, to become resistant to antibiotics. This means the bacteria might not be killed by the antibiotic anymore, which can make infections harder to treat. The study aims to understand how the use of ciprofloxacin might change the bacteria in the gut and whether it leads to resistance.

Investigated diseases:

Antimicrobial resistance in Escherichia coli – This condition occurs when Escherichia coli, a common bacterium found in the human gut, becomes resistant to antimicrobial drugs, such as antibiotics. The resistance develops through genetic mutations or by acquiring resistance genes from other bacteria. As resistance increases, the effectiveness of antibiotics in treating infections caused by E. coli diminishes. This can lead to longer-lasting infections and increased transmission of resistant strains. The progression of antimicrobial resistance can vary, with some strains becoming resistant more quickly than others. Monitoring and understanding the shifts in resistance patterns are crucial for managing and controlling the spread of resistant E. coli.

Trial ID:
2023-506205-18-00
Protocol code:
ITM202301
Trial Phase:
Therapeutic exploratory (Phase II)

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