nctId: NCT06368804 id: ANTEIPA id: 2022-A01575-38 type: OTHER domain: ID-RCB briefTitle: Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis acronym: ANTEIPA overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-11-01 date: 2028-06-01 date: 2024-04-16 date: 2024-04-18 name: Centre Hospitalier Intercommunal Creteil class: OTHER name: Assistance Publique - Hôpitaux de Paris briefSummary: 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. conditions: Bronchiectasis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 196 type: ESTIMATED name: Antibiotic monotherapy treatment and follow-up name: Antibiotic bitherapy treatment and follow-up measure: PA-eradication rate measure: Time to first exacerbation measure: 1 year-exacerbation rate measure: Quality-of-life using questionnaires measure: Quality-of-life using questionnaires measure: Treatment burden assessment using questionnaires measure: Quality-of-life using questionnaires measure: Detection of PA at 3-month and 1 year measure: Time to first PA-recurrence measure: Emergence of FQ-resistant strains of (PA or other bacteria) measure: Adverse event (AE) and serious AE at 12 months follow-up measure: Number of premature ending of one of the treatment in study due to any AE measure: Number of premature ending of one of the treatment in study measure: Proportion of non-administered doses of nebulized colistin measure: Cost and incremental cost effectiveness ratio at 1 year measure: Cost and incremental cost effectiveness ratio at 1 year measure: Cost and incremental cost effectiveness ratio at 1 year sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens-Picardie city: Amiens country: France name: Damien BASILLE role: CONTACT lat: 49.9 lon: 2.3 facility: CHU Haut Leveque, Bordeaux city: Bordeaux country: France name: Julie MACEY role: CONTACT lat: 44.84044 lon: -0.5805 facility: CHRU Brest city: Brest country: France name: Francis COUTURAUD role: CONTACT lat: 48.3903 lon: -4.48628 facility: CH Pontoise city: Cergy-Pontoise country: France name: Bruno PHILIPPE role: CONTACT lat: 49.03894 lon: 2.07805 facility: Centre hospitalier intercommunal de Créteil city: Créteil zip: 94010 country: France name: Bernard MAITRE role: CONTACT lat: 48.78333 lon: 2.46667 facility: APHP, Henri Mondor city: Créteil country: France name: Fréderic SCHLEMMER role: CONTACT lat: 48.78333 lon: 2.46667 facility: Hôpital de la Croix Rousse, HCL, Lyon city: Lyon country: France name: Gilles DEVOUASSOUX role: CONTACT lat: 45.74848 lon: 4.84669 facility: CHU Nantes city: Nantes country: France name: François-Xavier BLANC role: CONTACT lat: 47.21725 lon: -1.55336 facility: CHU H. Pasteur, Nice city: Nice country: France name: Sylvie LEROY role: CONTACT lat: 43.70313 lon: 7.26608 facility: APHP, Cochin city: Paris country: France name: Clémence MARTIN role: CONTACT lat: 48.85341 lon: 2.3488 facility: APHP, Saint Louis city: Paris country: France name: Abdellatif TAZI role: CONTACT lat: 48.85341 lon: 2.3488 facility: APHP, Tenon city: Paris country: France name: Nathalie ROZENSTAJ role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Foch, Suresnes city: Suresnes country: France name: Emilie CATHERINOT role: CONTACT lat: 48.87143 lon: 2.22929 facility: CHU H. Larrey, Toulouse city: Toulouse country: France name: Marlene MURIS-ESPIN role: CONTACT lat: 43.60426 lon: 1.44367 facility: CH Versailles city: Versailles country: France name: Charlotte COLIN role: CONTACT lat: 48.8 lon: 2.13333 facility: CH Villefranche s/Saône city: Villefranche-sur-Saône country: France name: Sonia BLANDIN role: CONTACT lat: 45.98333 lon: 4.71667 hasResults: False