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Can a simpler antibiotic course clear lung infections as well as a stronger one?

NCT ID NCT06368804

Disease control Sponsor: Centre Hospitalier Intercommunal Creteil Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests two antibiotic strategies for adults with bronchiectasis who have a first or recent Pseudomonas aeruginosa lung infection. One group receives a single oral antibiotic plus an inhaled antibiotic for three months, while the other gets a combination of additional antibiotics. Researchers will compare how often each approach clears the infection six months after starting treatment, and also track flare-ups and quality of life over a year. The goal is to find which regimen works best and is easier for patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Two antibiotic regimens: one with a single oral antibiotic (ciprofloxacin) plus inhaled colistimethate, and another combining additional antibiotics.
What this could lead to
If one regimen proves better or equally effective with fewer side effects, it could become the standard way to clear early Pseudomonas infections in bronchiectasis, potentially reducing flare-ups and improving quality of life.
What could go wrong
This is a phase 2 trial with 196 participants, so results may not apply to everyone. Antibiotics can cause side effects like kidney issues or allergic reactions, and the infection may return despite treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 196 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ≥18 years of age * Diagnosis of bronchiectasis on thoracic CT-scan * Recent isolation of P. aeruginosa (PA) in a respiratory sample (spontaneous or induced sputum or other lower respiratory tract sample obtained by bronchoscopy) within the last 3 months, with a PA positive respiratory sample obtained ≤ 3 weeks before randomization * Patient either Pseudomonas naive (i.e., never previously isolated PA) or Pseudomonas free (i.e., infection-free for ≥1 year, proven by at least two PA negative respiratory sample during the last year) * Patient affiliated with the French health care system * Able to understand and sign a written informed consent form Exclusion Criteria: * Confirmed diagnosis of cystic fibrosis * Pregnancy or breastfeeding * Women of childbearing potential (after the first menstrual period and until menopause or permanent sterility (hysterectomy, bilateral salpingectomy and bilateral oophorectomy)) who refuse to use effective contraception (hormonal or mechanical) for 3 months and/or to undergo pregnancy tests at baseline, 1 month and 3 months after baseline. * Isolation of PA in a respiratory specimen (spontaneous or induced sputum or other lower respiratory tract specimen obtained by bronchoscopy) more than 3 months to 12 months prior to randomization. * PA resistant to ciprofloxacin or ceftazidime * Severe exacerbation requiring admission to an intensive care unit (e.g. for non-invasive ventilatory support, invasive mechanical ventilation, catecholamine or any other organ supportive therapy) * Prior severe reaction, hypersensitivity reaction or other contraindication to any of the treatments in study (ciprofloxacin, beta-lactam, colistimethate sodium) * Prior severe bronchospasm attributed to a nebulization * Patients already receiving PA suppressive therapy with an inhaled antibiotic (long-term azithromycin therapy accepted) * Prior PA-eradication antibiotic treatment (systemic antibiotic(s) active against PA for ≥ 14 days or nebulized anti-PA antibiotic) within the last year * Antibiotic treatment active against PA (anti-PA beta-lactam antibiotic and/or FQ and/or aminoglycoside) for more than 3 days before randomisation * Active cancer or haematological malignancy under active therapy * Systemic corticosteroid therapy ≥ 20 mg/d. prednisone equivalent for a predictable duration \> 4 weeks * Non-tuberculous mycobacterial infection or positive non-tuberculous mycobacterial respiratory specimen within 1 year prior to inclusion * Severe chronic renal failure defined by a creatinine clearance (Cockcroft or MDRD) ≤ 30 mL/min/1.73m2 or chronic haemodialysis * Severe hepatic impairment * Long-term oxygen therapy and/or noninvasive mechanical ventilation for chronic respiratory insufficiency (except continuous positive airway pressure for OSA) and/or forced expiratory volume at one second (FEV1) \<25% of predicted value. * Patient participating to another interventional clinical trial

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Conditions

The condition(s) this trial relates to.

bronchiectasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bronchiectasis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHP, Cochin

    RECRUITING

    Paris, France

  • APHP, Henri Mondor

    RECRUITING

    Créteil, France

  • APHP, Saint Louis

    RECRUITING

    Paris, France

  • APHP, Tenon

    RECRUITING

    Paris, France

  • CH Pontoise

    RECRUITING

    Cergy-Pontoise, France

  • CH Versailles

    RECRUITING

    Versailles, France

  • CH Villefranche s/Saône

    RECRUITING

    Villefranche-sur-Saône, France

  • CHRU Brest

    RECRUITING

    Brest, France

  • CHU Amiens-Picardie

    RECRUITING

    Amiens, France

  • CHU H. Larrey, Toulouse

    RECRUITING

    Toulouse, France

  • CHU H. Pasteur, Nice

    NOT_YET_RECRUITING

    Nice, France

  • CHU Haut Leveque, Bordeaux

    RECRUITING

    Bordeaux, France

  • CHU Nantes

    RECRUITING

    Nantes, France

  • Centre hospitalier intercommunal de Créteil

    RECRUITING

    Créteil, 94010, France

  • Clinique St Joseph

    RECRUITING

    Marseille, 13008, France

  • Hôpital Foch, Suresnes

    RECRUITING

    Suresnes, France

  • Hôpital Pitié Salpêtrière

    RECRUITING

    Paris, 75013, France

  • Hôpital de la Croix Rousse, HCL, Lyon

    NOT_YET_RECRUITING

    Lyon, France

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