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L'essai clinique NCT06368804 (ANTEIPA) pour Bronchectasie est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis (ANTEIPA)
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L'essai clinique NCT06368804 (ANTEIPA) est conçu pour étudier le treatment de Bronchectasie. Il s'agit d'un essai interventionnel en Phase II. Son statut actuel est : en recrutement. L'essai a débuté le 15 septembre 2024 et vise à recruter 196 participants. Dirigé par Centre Hospitalier Intercommunal Creteil, l'essai devrait être terminé d'ici le 15 septembre 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 17 juillet 2025.
Résumé succinct
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.
Description détaillée
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.
Titre officiel
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.
Conditions
BronchectasieAutres identifiants de l'essai
- ANTEIPA
- 2022-A01575-38 (Autre Identifiant) (ID-RCB)
Numéro NCT
Date de début (réel)
2024-09-15
Dernière mise à jour publiée
2025-07-17
Date de fin (estimée)
2028-09-15
Inscription (estimée)
196
Type d'essai
Interventionnel
PHASE
Phase II
Statut
En recrutement
Mots clés
Non cystic fibrosis bronchiectasis
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalOral fluoroquinolone + nebulized colistimethate sodium | Antibiotic Monotherapy Treatment and Follow-up 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) ;
2. a subsequent follow-up period of 9 months (i.e. until 12 months after the start of antibiotic therapy against Pseudomonas aeruginosa). |
Comparateur actifIV beta-lactam antibiotic (ceftazidime) + oral fluoroquinolone + nebulized colistimethate sodium | Antibiotic Bitherapy Treatment and Follow-up 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) ;
2. a subsequent follow-up period of 9 months (i.e. until 12 months after the start of antibiotic therapy against Pseudomonas aeruginosa). |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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. | 6 months |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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 | 3, 6 and 12 months-follow up visit, or additional visit |
1 year-exacerbation rate | exacerbation assessment at each follow-up visit | 3, 6 and 12 months-follow up visit |
Quality-of-life using questionnaires | Quality of Life-Bronchiectasis (QOL-B) | Inclusion, 3 and 12 months-follow up visit |
Quality-of-life using questionnaires | Bronchiectasis Impact Measure (BIM) | Inclusion, 3 and 12 months-follow up visit |
Treatment burden assessment using questionnaires | Treatment Burden Questionnaire (TBQ) | Inclusion, 3 and 12 months-follow up visit |
Quality-of-life using questionnaires | EQ-5D-5L questionnaire for the medico-economic analysis | Inclusion, 3 and 12 months-follow up visit |
Detection of PA at 3-month and 1 year | Sputum (or lower respiratory tract sample, if clinically justified) culture growing PA | 3 and 12 months-follow up visit |
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 | 3, 6 and 12 months-follow up visit |
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 | 3, 6 and 12 months-follow up visit |
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 | during the 12 months follow-up |
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) | 1 months and 3 months-follow up visit |
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) | 1 months and 3 months-follow up visit |
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) | 1 months and 3 months-follow up visit |
Cost and incremental cost effectiveness ratio at 1 year | Total cost in each group | 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. |
Cost and incremental cost effectiveness ratio at 1 year | Total quality adjusted life years (QALYs) in each group | 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. |
Cost and incremental cost effectiveness ratio at 1 year | Difference in costs /difference in QALYs | 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. |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- ≥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
- 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
Centre Hospitalier Intercommunal CreteilAssistance publique - Hôpitaux de ParisContact central de l'essai
Contact: Camille JUNG, MD, 0157022000, [email protected]
18 Centres de l'essai dans 1 pays
CHU Amiens-Picardie, Amiens, France
Damien BASILLE, Contact
En recrutement
CHU Haut Leveque, Bordeaux, Bordeaux, France
Julie MACEY, Contact
En recrutement
CHRU Brest, Brest, France
Francis COUTURAUD, Contact
En recrutement
CH Pontoise, Cergy-Pontoise, France
Bruno PHILIPPE, Contact
En recrutement
Centre hospitalier intercommunal de Créteil, Créteil, 94010, France
Bernard MAITRE, Contact
En recrutement
APHP, Henri Mondor, Créteil, France
Fréderic SCHLEMMER, Contact
En recrutement
Hôpital de la Croix Rousse, HCL, Lyon, Lyon, France
Gilles DEVOUASSOUX, Contact
Pas encore en recrutement
Clinique St Joseph, Marseille, 13008, France
Cristina AUDOLY, MD, Contact, [email protected]
En recrutement
CHU Nantes, Nantes, France
François-Xavier BLANC, Contact
En recrutement
CHU H. Pasteur, Nice, Nice, France
Sylvie LEROY, Contact
Pas encore en recrutement
Hôpital Pitié Salpêtrière, Paris, 75013, France
Christophe CRACCO, MD, Contact, [email protected]
En recrutement
APHP, Cochin, Paris, France
Clémence MARTIN, Contact
En recrutement
APHP, Saint Louis, Paris, France
Abdellatif TAZI, Contact
En recrutement
APHP, Tenon, Paris, France
Nathalie ROZENSTAJ, Contact
En recrutement
Hôpital Foch, Suresnes, Suresnes, France
Emilie CATHERINOT, Contact
En recrutement
CHU H. Larrey, Toulouse, Toulouse, France
Marlene MURIS-ESPIN, Contact
En recrutement
CH Versailles, Versailles, France
Charlotte COLIN, Contact
En recrutement
CH Villefranche s/Saône, Villefranche-sur-Saône, France
Sonia BLANDIN, Contact
En recrutement