Efficacy and safety of colistimethate sodium and ciprofloxacin regimens for eradicating Pseudomonas aeruginosa infection in adults with bronchiectasis

3 1 1

What is this study about?

The trial focuses on adults with Bronchiectasis who have a new infection caused by the bacterium Pseudomonas aeruginosa. The study compares three antibiotic approaches: an inhaled solution containing colistimethate sodium, oral tablets of ciprofloxacin, and a control treatment that looks the same but contains only saline, referred to as placebo.

The purpose of the study is to find out which of these regimens is most effective at clearing the bacteria. Participants are randomly assigned to one of the three groups, receive the assigned medication for a short course, and then are monitored over several months with clinic visits and sample collections.

Effectiveness is judged by microbiological eradication, meaning that laboratory tests no longer detect the bacteria in sputum or other samples after treatment. Additional observations include how often respiratory flare‑ups occur, any side effects, overall well‑being, and any changes in blood tests. The follow‑up continues up to a year to see if the benefit lasts.

1 first dose and instructions

on the day you are assigned to a treatment group you receive the medication kit.

the kit contains either colistimethate sodium for inhalation, a matching placebo inhalation solution, and oral ciprofloxacin tablets.

written instructions explain how to use the nebuliser for inhalation and how to take the tablets.

2 daily medication administration

you use the nebuliser each day to inhale 4 million iu of the assigned solution (colistimethate sodium or placebo) by the route of inhalation.

you also take oral ciprofloxacin tablets totaling 750 mg each day; the dose can be taken as three 250 mg tablets or as one 500 mg tablet plus one 250 mg tablet, according to the instructions.

the daily regimen continues for a total of three months.

3 early safety check

one week after starting treatment you receive a brief phone call to report any side effects and to confirm that you are able to use the nebuliser correctly.

4 month‑1 visit

at the first month you attend a clinic visit.

clinical staff collect a sputum sample to test for microbiological eradication of p. aeruginosa.

they also review any adverse events and check your inhalation technique.

5 month‑2 visit

a second clinic visit occurs at two months.

another sputum sample is taken to assess early eradication.

safety assessments and medication adherence are reviewed.

6 month‑3 visit (end of treatment)

the primary outcome is measured at three months.

a sputum or bronchoscopic sample is collected to determine if p. aeruginosa is no longer present.

the study medication is stopped after this visit.

final safety evaluations for the treatment period are performed.

7 month‑6 follow‑up

six months after the start of treatment you return for a follow‑up visit.

a sputum sample is taken to assess sustained eradication.

ongoing safety and any new respiratory events are recorded.

8 month‑12 follow‑up

twelve months after the start of treatment a final visit is scheduled.

the last sputum sample is collected to evaluate long‑term eradication.

final safety assessments and quality‑of‑life questionnaires are completed.

Who Can Join the Study?

  • Be 18 years of age or older.
  • Be either male or female.
  • Have a diagnosis of non‑cystic fibrosis bronchiectasis (NCFB) confirmed by symptoms and a special chest scan called a high‑resolution CT (HRCT) that was done within the last five years.
  • Have a primary infection with Pseudomonas aeruginosa (PA), a type of bacteria that can live in the lungs. This must be shown by a lab test on a respiratory sample (such as sputum you cough up or a sample taken during a bronchoscopy) and meet one of these patterns: the bacteria is being found for the first time; the bacteria is still present four weeks after completing antibiotic treatment; or the bacteria shows up again after at least three separate negative tests in the past year with no long‑term anti‑PA medicine.
  • Be clinically stable when joining the study – meaning you have not had an exacerbation (flare‑up) in the past month and you do not need intravenous antibiotics or a hospital stay.
  • Be willing to sign an informed consent form, showing you understand the study and agree to take part.

Who Cannot Join the Study?

  • Having an infection with PA (a type of bacteria called Pseudomonas aeruginosa) that does not respond to the study medicines, or having an infection caused by other bacteria.
  • Being enrolled in another clinical trial at the same time.
  • Choosing not to take part in the study.
  • Having medical reasons that make the study drugs ciprofloxacin or colistin unsafe for you.
  • Having a past reaction that makes it difficult to tolerate inhaled medicine delivered by a nebulizer (a device that turns liquid medicine into a fine mist).
  • Having any of the following conditions: cystic fibrosis (a genetic lung disease), uncontrolled asthma (lung inflammation that is not well‑controlled), tuberculosis (a serious lung infection), or a weakened immune system (immunosuppression).
  • Having serious health problems that have not been under control in the past three months.
  • Taking antibiotics on a long‑term, regular basis.
  • Having kidney function measured by glomerular filtration rate (a test of how well the kidneys filter waste) that is less than 30 ml/min/1.73 m².
  • Being a woman who could become pregnant and not using a very reliable contraceptive method (birth control).
  • Being pregnant or breastfeeding.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Fundacio Hospital Sant Joan De Deu De Martorell Martorell Spain

Other Sites

Site Name City Country Status
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario De Getafe Getafe Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada Manresa Spain
Hlnwbnvq Vijg doaxlnvd Barcelona Spain
Hbjqmkxz Dq Lr Sjkkd Cngq I Szyy Psb Barcelona Spain
Fojzbljgi Pcei Lo Itxwbqtlnzwoz Bvsqlofng Duo Hueycrat Uwishcwtfilve La Pig Madrid Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
01.04.2026

Trial locations

Colistin is an antibiotic that is given by inhalation using a nebulizer. In this trial it is used as a spray that patients breathe in, delivering the medicine directly to the lungs where the infection is located. The goal of using colistin is to try to clear the Pseudomonas aeruginosa bacteria from the airways of people with bronchiectasis.

Ciprofloxacin is an oral antibiotic taken as a tablet. In the study participants swallow the tablet, and the medicine works throughout the body, including the lungs, to fight the Pseudomonas aeruginosa infection. The purpose of ciprofloxacin in the trial is to see if taking this pill can eliminate the bacteria and improve the condition of patients with bronchiectasis.

Bronchiectasis – Bronchiectasis is a condition where the airways in the lungs become widened and damaged. This leads to a buildup of mucus that is hard to clear. Over time the airways become scarred and less able to move air efficiently. People may experience frequent coughing and produce more sputum. The damage can worsen gradually, making breathing more difficult as the airway walls become more rigid.

Trial ID:
2025-524454-34-00
Protocol code:
IIBSP-PAB-2025-212
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

  • A study testing GSK3862995B compared to placebo for safety and effectiveness in adults aged 18 to 85 years with bronchiectasis

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Germany Italy Poland Spain
  • A study to evaluate the safety and effectiveness of AZD0292 in people aged 12 years and older with bronchiectasis and chronic Pseudomonas aeruginosa infection

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark France Germany Greece Italy +2