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BronchiectasisPhase 2ANTEIPANCT06368804

Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis

A Phase 2 study testing Antibiotic monotherapy treatment and follow-up and Antibiotic bitherapy treatment and follow-up in people with Bronchiectasis, run by Centre Hospitalier Intercommunal Creteil at 18 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Chronic airways infection with Pseudomonas aeruginosa (PA) is associated with increased frequency of exacerbations, deterioration in quality of life and increased mortality in adult patients with bronchiectasis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bronchiectasis
What is being tested?
Antibiotic monotherapy treatment and follow-up and Antibiotic bitherapy treatment and follow-up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
18 sitesFrance
Study dates
15 Sep 2024to 15 Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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

Who cannot join

  • 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)
Show all 18Show fewer
  • 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

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Camille JUNG, MD contact

0157022000 ext. 8429

camille.jung@chicreteil.fr

18 sites in 1 country

France18 sites, 18 recruiting

  • CHU Amiens-Picardie

    Amiens

    Damien BASILLE

    Recruiting

  • CHU Haut Leveque, Bordeaux

    Bordeaux

    Julie MACEY

    Recruiting

  • CHRU Brest

    Brest

    Francis COUTURAUD

    Recruiting

  • CH Pontoise

    Cergy-Pontoise

    Bruno PHILIPPE

    Recruiting

  • Centre hospitalier intercommunal de Créteil

    Créteil, 94010

    Bernard MAITRE

    Recruiting

  • APHP, Henri Mondor

    Créteil

    Fréderic SCHLEMMER

    Recruiting

  • Hôpital de la Croix Rousse, HCL, Lyon

    Lyon

    Gilles DEVOUASSOUX

    Not yet recruiting

  • Clinique St Joseph

    Marseille, 13008

    Cristina AUDOLY, MD, caudoly@hopital-saint-joseph.fr

    Recruiting

  • CHU Nantes

    Nantes

    François-Xavier BLANC

    Recruiting

  • CHU H. Pasteur, Nice

    Nice

    Sylvie LEROY

    Not yet recruiting

  • Hôpital Pitié Salpêtrière

    Paris, 75013

    Christophe CRACCO, MD, christophe.cracco@aphp.fr

    Recruiting

  • APHP, Cochin

    Paris

    Clémence MARTIN

    Recruiting

  • APHP, Saint Louis

    Paris

    Abdellatif TAZI

    Recruiting

  • APHP, Tenon

    Paris

    Nathalie ROZENSTAJ

    Recruiting

  • Hôpital Foch, Suresnes

    Suresnes

    Emilie CATHERINOT

    Recruiting

  • CHU H. Larrey, Toulouse

    Toulouse

    Marlene MURIS-ESPIN

    Recruiting

  • CH Versailles

    Versailles

    Charlotte COLIN

    Recruiting

  • CH Villefranche s/Saône

    Villefranche-sur-Saône

    Sonia BLANDIN

    Recruiting

Other trials in France

About this study

Official title: Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With Pseudomonas Aeruginosa in Adults With Bronchiectasis: a Non-inferiority Randomized Controlled Trial.

Chronic airways infection with Pseudomonas aeruginosa (PA) is associated with increased frequency of exacerbations, deterioration in quality of life and increased mortality in adult patients with bronchiectasis. Current guidelines suggest the prescription of an eradication antibiotic treatment for a first episode of PA infection (early PA infection). Several antibiotic regimens may be proposed, ranging from a monotherapy with oral fluoroquinolone (FQ) to an intravenous cotherapy with the addition of inhaled antibiotics that seems to improve the rate of PA eradication. As no study strictly favoured one regimen, current practices are heterogeneous and could certainly benefit from stronger evidence, with both medical and economic impact.

Read the detailed description

According to current knowledge, the early combination of an oral FQ to an inhaled antibiotic could be an acceptable alternative to a systemic cotherapy. Indeed, such regimen allows avoiding IV drugs use, facilitating ambulatory management and influencing patient's quality of life and costs, and may achieve similar PA-eradication rate.

Conditions
Bronchiectasis
Being tested
Antibiotic monotherapy treatment and follow-up, Antibiotic bitherapy treatment and follow-up
Keywords
Non cystic fibrosis bronchiectasis
Medical subject headings
Bronchiectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antibiotic monotherapy treatment and follow-upDrug

    1. a 3-months treatment period, including:
    • an initial phase of 14 days, combining an oral fluoroquinolone (ciprofloxacin 750mg tw/d) with nebulized sodium colistimethate (1 Million Units tw/d)
    • a maintenance phase of 2.5 months: nebulized sodium colistimethate (1 MU tw/d) ;
    1. a subsequent follow-up period of 9 months (i.e. until 12 months after the start of antibiotic therapy against Pseudomonas aeruginosa).

  • Antibiotic bitherapy treatment and follow-upDrug

    1. a 3-months treatment period, including:
    • an initial phase of 14 days, combining an IV beta-lactam antibitic (ceftazidime 4 or 6g/d) and an oral fluoroquinolone (ciprofloxacin 750mg tw/d) with nebulized sodium colistimethate (1 Million Units tw/d)
    • a maintenance phase of 2.5 months: nebulized sodium colistimethate (1 MU tw/d) ;
    1. a subsequent follow-up period of 9 months (i.e. until 12 months after the start of antibiotic therapy against Pseudomonas aeruginosa).
Study groups in NCT06368804
Study groupRoleWhat they receive
Oral fluoroquinolone + nebulized colistimethate sodiumExperimentalNot described
Receives: Drug: Antibiotic monotherapy treatment and follow-up
IV beta-lactam antibiotic (ceftazidime) + oral fluoroquinolone + nebulized colistimethate sodiumActive comparatorNot described
Receives: Drug: Antibiotic bitherapy treatment and follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PA-eradication rate

    PA-eradication rate 6 months after the start of antibiotic therapy targeting PA, where PA eradication is defined as follows:

    • Sputum culture (or lower airway specimen culture, if respiratory exacerbation* with inability to perform good quality sputum analysis) negative for PA at the 6-month follow-up visit, or
    • Inability to spit in the absence of a pulmonary exacerbation*, AND
    • No sputum culture or lower airway specimen positive for PA between D90 of antibiotic treatment and the 6-month follow-up visit, in the absence of new antibiotic therapy targeting PA.

    Measured: 6 months

Secondary outcomes (16)

  1. Time to first exacerbation

    exacerbation assessment at each follow-up visit, with time (in days) between the start of antibiotic therapy against PA and first exacerbation

    Measured: 3, 6 and 12 months-follow up visit, or additional visit

  2. 1 year-exacerbation rate

    exacerbation assessment at each follow-up visit

    Measured: 3, 6 and 12 months-follow up visit

  3. Quality-of-life using questionnaires

    Quality of Life-Bronchiectasis (QOL-B)

    Measured: Inclusion, 3 and 12 months-follow up visit

  4. Quality-of-life using questionnaires

    Bronchiectasis Impact Measure (BIM)

    Measured: Inclusion, 3 and 12 months-follow up visit

  5. Treatment burden assessment using questionnaires

    Treatment Burden Questionnaire (TBQ)

    Measured: Inclusion, 3 and 12 months-follow up visit

  6. Quality-of-life using questionnaires

    EQ-5D-5L questionnaire for the medico-economic analysis

    Measured: Inclusion, 3 and 12 months-follow up visit

  7. Detection of PA at 3-month and 1 year

    Sputum (or lower respiratory tract sample, if clinically justified) culture growing PA

    Measured: 3 and 12 months-follow up visit

  8. Time to first PA-recurrence

    PA-recurrence in sputum (or lower respiratory tract sample, if clinically justified), with time (in days) between the start of antibiotic therapy against PA and first PA-recurrence

    Measured: 3, 6 and 12 months-follow up visit

  9. Emergence of FQ-resistant strains of (PA or other bacteria)

    analysis of PA (or other bacteria) susceptibility to ciprofloxacin, if growing on respiratory sample(s) performed between 3 months and 12 months

    Measured: 3, 6 and 12 months-follow up visit

  10. Adverse event (AE) and serious AE at 12 months follow-up

    AE and serious AEs will be recorded during medical interviews and by self-report in the study booklet during the study

    Measured: during the 12 months follow-up

  11. Number of premature ending of one of the treatment in study due to any AE

    Compliance to treatment and AEs will be recorded during medical interviews and by self-report in the study booklet during the study treatment period, time (in days)

    Measured: 1 months and 3 months-follow up visit

  12. Number of premature ending of one of the treatment in study

    Compliance to treatment will be recorded during medical interviews and by self-report in the study booklet during the study treatment period, time (in days)

    Measured: 1 months and 3 months-follow up visit

  13. Proportion of non-administered doses of nebulized colistin

    Compliance to treatment will be recorded during medical interviews and by self-report in the study booklet during the study treatment period, time (in days)

    Measured: 1 months and 3 months-follow up visit

  14. Cost and incremental cost effectiveness ratio at 1 year

    Total cost in each group

    Measured: Inclusion and each follow up visit up to one year for quality of life measures; initial discharge and subsequent exacerbation-related readmissions up to one year.

  15. Cost and incremental cost effectiveness ratio at 1 year

    Total quality adjusted life years (QALYs) in each group

    Measured: Inclusion and each follow up visit up to one year for quality of life measures; initial discharge and subsequent exacerbation-related readmissions up to one year.

  16. Cost and incremental cost effectiveness ratio at 1 year

    Difference in costs /difference in QALYs

    Measured: Inclusion and each follow up visit up to one year for quality of life measures; initial discharge and subsequent exacerbation-related readmissions up to one year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2024
  2. Study start15 Sep 2024
  3. Primary completion15 Mar 2025
  4. Study completion15 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
196 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06368804
Sponsor's protocol ID
ANTEIPA
Other IDs
2022-A01575-38
Acronym
ANTEIPA
Status last verified
Aug 2026
First submitted
22 Feb 2024
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Antibiotic monotherapy treatment and follow-up and Antibiotic bitherapy treatment and follow-up in people with Bronchiectasis, run by Centre Hospitalier Intercommunal Creteil at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Camille JUNG, MD (0157022000 ext. 8429, camille.jung@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PA-eradication rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06368804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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