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Study Comparing Ciprofloxacin, Colistimethate Sodium, and Ceftazidime for Treating Early Airway Infection in Adults with Bronchiectasis

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 clinical trial is focused on studying the treatment of bronchiectasis, a lung condition where the airways become widened, leading to a build-up of mucus that can make the lungs more vulnerable to infection. The study is comparing two different antibiotic treatments to see which is more effective in treating early infections caused by a bacteria called Pseudomonas aeruginosa (PA) in adults with bronchiectasis. The first treatment involves taking an oral antibiotic called ciprofloxacin for 14 days, combined with inhaling a medication called colistimethate sodium (also known as colistin) for 3 months. The second treatment involves a 14-day course of antibiotics given by injection, including a type of antibiotic known as a beta-lactam, along with the same 3-month inhalation of colistimethate sodium.

The purpose of the study is to determine if the first treatment option is not worse than the second in terms of clearing the PA infection over a period of 6 months. Participants will be monitored for 6 months to see if the PA infection is eradicated. The study will also look at other factors such as the time it takes for any worsening of symptoms, the quality of life of participants, and how burdensome the treatment is. Additionally, the study will assess the recurrence of PA and the bacteria's resistance to ciprofloxacin over time.

Participants will be asked to take part in regular follow-up visits to monitor their health and the effectiveness of the treatment. They will also complete questionnaires to help assess their quality of life and the impact of the treatment. The study aims to provide valuable information on the best way to treat early PA infections in people with bronchiectasis, potentially improving treatment strategies and patient outcomes in the future.

The research process

The trial runs in 6 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, eligibility is confirmed based on criteria such as age, diagnosis of bronchiectasis, and recent isolation of P. aeruginosa in a respiratory sample.

    Informed consent is required, ensuring understanding of the study's purpose and procedures.

  2. Step 2

    Initial treatment phase

    The treatment begins with a 14-day course of oral ciprofloxacin.

    Simultaneously, colistimethate sodium is administered through inhalation for a duration of 3 months.

  3. Step 3

    Alternative treatment phase

    Alternatively, a 14-day systemic dual therapy is provided, which includes an intravenous (IV) anti-PA beta-lactam.

    This is also combined with inhaled colistimethate sodium for 3 months.

  4. Step 4

    Follow-up and monitoring

    Regular follow-up visits are scheduled to assess exacerbations and monitor the eradication of P. aeruginosa.

    Quality of life and treatment burden are evaluated using specific questionnaires.

  5. Step 5

    Assessment of outcomes

    The primary outcome is the eradication rate of P. aeruginosa 6 months after starting the antibiotic therapy.

    Secondary outcomes include the time to first exacerbation, recurrence of P. aeruginosa, and analysis of bacterial susceptibility to ciprofloxacin.

  6. Step 6

    Completion of study

    The study is expected to conclude by March 2028, with all data collected and analyzed to determine the effectiveness of the treatment regimens.

Who can join the trial?

6 criteria

  • Must be at least 18 years old.
  • Have a diagnosis of bronchiectasis, which is a lung condition, confirmed by a special type of X-ray called a thoracic CT-scan.
  • Recently had a specific type of bacteria called P. aeruginosa found in a sample from the lungs or airways within the last 3 months. This sample should be positive for the bacteria within 3 weeks before joining the study.
  • Either never had the Pseudomonas bacteria before or have been free from it for at least 1 year, confirmed by at least two negative tests for the bacteria in the past year.
  • Must be part of the French health care system.
  • Able to understand and sign a written consent form, which is a document that explains the study and confirms your agreement to participate.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with bronchiectasis, a condition where the airways in the lungs become widened and can lead to infections.
  • Patients who are not within the specified age range for the study.
  • Patients who do not meet the specific health conditions required for the study.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care.
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Investigated drugs

  • Ciprofloxacin

    is an antibiotic used in this trial to treat early airways infection in adults with bronchiectasis. It is taken orally for 14 days and works by killing bacteria or preventing their growth.

  • Colistimethate Sodium (Colistin)

    is an antibiotic administered through a nebulizer, which means it is inhaled directly into the lungs. In this trial, it is used for 3 months to help eradicate the infection in the airways.

  • IV Anti-PA Beta-Lactam

    is a type of antibiotic given through an intravenous (IV) line. It is part of a systemic dual therapy used for 14 days in this trial to treat the infection. This medication helps to kill bacteria that are resistant to other antibiotics.

What is already known about the treatment

  • Ciprofloxacin

    This medication is administered orally and is currently being studied for its effectiveness in treating early airway infections in adults with bronchiectasis. It is a well-established antibiotic in medical literature, primarily used to treat various bacterial infections. Ciprofloxacin works by inhibiting bacterial DNA gyrase, an enzyme necessary for DNA replication, thus preventing bacterial growth. It belongs to the pharmacological class of fluoroquinolone antibiotics.

  • Colistimethate Sodium (Colistin)

    This medication is administered through nebulization and is being evaluated for its role in treating early airway infections in bronchiectasis. It is recognized in medical literature as an antibiotic used for treating infections caused by certain bacteria. Colistin acts by disrupting the bacterial cell membrane, leading to cell death. It is classified as a polymyxin antibiotic.

Investigated diseases

Bronchiectasis – This is a chronic lung condition where the airways become widened and scarred, leading to a build-up of mucus. Over time, this can cause frequent lung infections and breathing difficulties. The disease progresses as the airways continue to be damaged, resulting in persistent cough, production of sputum, and recurrent respiratory infections. As the condition advances, individuals may experience fatigue, shortness of breath, and chest pain. The progression can vary, with some people experiencing rapid worsening of symptoms, while others may have a more gradual decline. Regular monitoring and management are essential to help control symptoms and prevent further lung damage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504755-26-00Protocol codeANTEIPAEstimated enrolment196 patientsSponsorCentre Hospitalier Intercommunal Creteil

sourced from the EU Clinical Trials Register and site verification

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