Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-29 @ 4:19 AM
Study NCT ID:
NCT06368804
Status:
RECRUITING
Last Update Posted:
2025-07-17
First Post:
2024-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 196}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2024-02-22', 'studyFirstSubmitQcDate': '2024-04-11', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PA-eradication rate', 'timeFrame': '6 months', 'description': 'PA-eradication rate 6 months after the start of antibiotic therapy targeting PA, where PA eradication is defined as follows:\n\n* 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\n* Inability to spit in the absence of a pulmonary exacerbation\\*, AND\n* 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.'}], 'secondaryOutcomes': [{'measure': 'Time to first exacerbation', 'timeFrame': '3, 6 and 12 months-follow up visit, or additional visit', 'description': 'exacerbation assessment at each follow-up visit, with time (in days) between the start of antibiotic therapy against PA and first exacerbation'}, {'measure': '1 year-exacerbation rate', 'timeFrame': '3, 6 and 12 months-follow up visit', 'description': 'exacerbation assessment at each follow-up visit'}, {'measure': 'Quality-of-life using questionnaires', 'timeFrame': 'Inclusion, 3 and 12 months-follow up visit', 'description': 'Quality of Life-Bronchiectasis (QOL-B)'}, {'measure': 'Quality-of-life using questionnaires', 'timeFrame': 'Inclusion, 3 and 12 months-follow up visit', 'description': 'Bronchiectasis Impact Measure (BIM)'}, {'measure': 'Treatment burden assessment using questionnaires', 'timeFrame': 'Inclusion, 3 and 12 months-follow up visit', 'description': 'Treatment Burden Questionnaire (TBQ)'}, {'measure': 'Quality-of-life using questionnaires', 'timeFrame': 'Inclusion, 3 and 12 months-follow up visit', 'description': 'EQ-5D-5L questionnaire for the medico-economic analysis'}, {'measure': 'Detection of PA at 3-month and 1 year', 'timeFrame': '3 and 12 months-follow up visit', 'description': 'Sputum (or lower respiratory tract sample, if clinically justified) culture growing PA'}, {'measure': 'Time to first PA-recurrence', 'timeFrame': '3, 6 and 12 months-follow up visit', 'description': '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'}, {'measure': 'Emergence of FQ-resistant strains of (PA or other bacteria)', 'timeFrame': '3, 6 and 12 months-follow up visit', 'description': 'analysis of PA (or other bacteria) susceptibility to ciprofloxacin, if growing on respiratory sample(s) performed between 3 months and 12 months'}, {'measure': 'Adverse event (AE) and serious AE at 12 months follow-up', 'timeFrame': 'during the 12 months follow-up', 'description': 'AE and serious AEs will be recorded during medical interviews and by self-report in the study booklet during the study'}, {'measure': 'Number of premature ending of one of the treatment in study due to any AE', 'timeFrame': '1 months and 3 months-follow up visit', 'description': '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)'}, {'measure': 'Number of premature ending of one of the treatment in study', 'timeFrame': '1 months and 3 months-follow up visit', 'description': '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)'}, {'measure': 'Proportion of non-administered doses of nebulized colistin', 'timeFrame': '1 months and 3 months-follow up visit', 'description': '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)'}, {'measure': 'Cost and incremental cost effectiveness ratio at 1 year', 'timeFrame': '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.', 'description': 'Total cost in each group'}, {'measure': 'Cost and incremental cost effectiveness ratio at 1 year', 'timeFrame': '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.', 'description': 'Total quality adjusted life years (QALYs) in each group'}, {'measure': 'Cost and incremental cost effectiveness ratio at 1 year', 'timeFrame': '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.', 'description': 'Difference in costs /difference in QALYs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non cystic fibrosis bronchiectasis'], 'conditions': ['Bronchiectasis']}, '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age\n* Diagnosis of bronchiectasis on thoracic CT-scan\n* 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\n* 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)\n* Patient affiliated with the French health care system\n* Able to understand and sign a written informed consent form\n\nExclusion Criteria:\n\n* Confirmed diagnosis of cystic fibrosis\n* Pregnancy or breastfeeding\n* 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.\n* 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.\n* PA resistant to ciprofloxacin or ceftazidime\n* 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)\n* Prior severe reaction, hypersensitivity reaction or other contraindication to any of the treatments in study (ciprofloxacin, beta-lactam, colistimethate sodium)\n* Prior severe bronchospasm attributed to a nebulization\n* Patients already receiving PA suppressive therapy with an inhaled antibiotic (long-term azithromycin therapy accepted)\n* Prior PA-eradication antibiotic treatment (systemic antibiotic(s) active against PA for ≥ 14 days or nebulized anti-PA antibiotic) within the last year\n* Antibiotic treatment active against PA (anti-PA beta-lactam antibiotic and/or FQ and/or aminoglycoside) for more than 3 days before randomisation\n* Active cancer or haematological malignancy under active therapy\n* Systemic corticosteroid therapy ≥ 20 mg/d. prednisone equivalent for a predictable duration \\> 4 weeks\n* Non-tuberculous mycobacterial infection or positive non-tuberculous mycobacterial respiratory specimen within 1 year prior to inclusion\n* Severe chronic renal failure defined by a creatinine clearance (Cockcroft or MDRD) ≤ 30 mL/min/1.73m2 or chronic haemodialysis\n* Severe hepatic impairment\n* 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.\n* Patient participating to another interventional clinical trial'}, 'identificationModule': {'nctId': 'NCT06368804', 'acronym': 'ANTEIPA', 'briefTitle': 'Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'ANTEIPA'}, 'secondaryIdInfos': [{'id': '2022-A01575-38', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral fluoroquinolone + nebulized colistimethate sodium', 'interventionNames': ['Drug: Antibiotic monotherapy treatment and follow-up']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV beta-lactam antibiotic (ceftazidime) + oral fluoroquinolone + nebulized colistimethate sodium', 'interventionNames': ['Drug: Antibiotic bitherapy treatment and follow-up']}], 'interventions': [{'name': 'Antibiotic monotherapy treatment and follow-up', 'type': 'DRUG', 'description': '1. a 3-months treatment period, including:\n\n * an initial phase of 14 days, combining an oral fluoroquinolone (ciprofloxacin 750mg tw/d) with nebulized sodium colistimethate (1 Million Units tw/d)\n * a maintenance phase of 2.5 months: nebulized sodium colistimethate (1 MU tw/d) ;\n2. a subsequent follow-up period of 9 months (i.e. until 12 months after the start of antibiotic therapy against Pseudomonas aeruginosa).', 'armGroupLabels': ['Oral fluoroquinolone + nebulized colistimethate sodium']}, {'name': 'Antibiotic bitherapy treatment and follow-up', 'type': 'DRUG', 'description': '1. a 3-months treatment period, including:\n\n * 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)\n * a maintenance phase of 2.5 months: nebulized sodium colistimethate (1 MU tw/d) ;\n2. a subsequent follow-up period of 9 months (i.e. until 12 months after the start of antibiotic therapy against Pseudomonas aeruginosa).', 'armGroupLabels': ['IV beta-lactam antibiotic (ceftazidime) + oral fluoroquinolone + nebulized colistimethate sodium']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Damien BASILLE', 'role': 'CONTACT'}], 'facility': 'CHU Amiens-Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie MACEY', 'role': 'CONTACT'}], 'facility': 'CHU Haut Leveque, Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Francis COUTURAUD', 'role': 'CONTACT'}], 'facility': 'CHRU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Cergy-Pontoise', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bruno PHILIPPE', 'role': 'CONTACT'}], 'facility': 'CH Pontoise', 'geoPoint': {'lat': 49.03894, 'lon': 2.07805}}, {'zip': '94010', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bernard MAITRE', 'role': 'CONTACT'}], 'facility': 'Centre hospitalier intercommunal de Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fréderic SCHLEMMER', 'role': 'CONTACT'}], 'facility': 'APHP, Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gilles DEVOUASSOUX', 'role': 'CONTACT'}], 'facility': 'Hôpital de la Croix Rousse, HCL, Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13008', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cristina AUDOLY, MD', 'role': 'CONTACT', 'email': 'caudoly@hopital-saint-joseph.fr'}], 'facility': 'Clinique St Joseph', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François-Xavier BLANC', 'role': 'CONTACT'}], 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvie LEROY', 'role': 'CONTACT'}], 'facility': 'CHU H. Pasteur, Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe CRACCO, MD', 'role': 'CONTACT', 'email': 'christophe.cracco@aphp.fr'}], 'facility': 'Hôpital Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clémence MARTIN', 'role': 'CONTACT'}], 'facility': 'APHP, Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Abdellatif TAZI', 'role': 'CONTACT'}], 'facility': 'APHP, Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nathalie ROZENSTAJ', 'role': 'CONTACT'}], 'facility': 'APHP, Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Suresnes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie CATHERINOT', 'role': 'CONTACT'}], 'facility': 'Hôpital Foch, Suresnes', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marlene MURIS-ESPIN', 'role': 'CONTACT'}], 'facility': 'CHU H. Larrey, Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Versailles', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charlotte COLIN', 'role': 'CONTACT'}], 'facility': 'CH Versailles', 'geoPoint': {'lat': 48.80359, 'lon': 2.13424}}, {'city': 'Villefranche-sur-Saône', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sonia BLANDIN', 'role': 'CONTACT'}], 'facility': 'CH Villefranche s/Saône', 'geoPoint': {'lat': 45.98967, 'lon': 4.71961}}], 'centralContacts': [{'name': 'Camille JUNG, MD', 'role': 'CONTACT', 'email': 'camille.jung@chicreteil.fr', 'phone': '0157022000', 'phoneExt': '8429'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'collaborators': [{'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}