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