Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-06 @ 5:35 PM
Study NCT ID:
NCT03494894
Status:
COMPLETED
Last Update Posted:
2020-08-04
First Post:
2018-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bacteriological Link Between Upper and Lower Airways in Cystic Fibrosis and Primary Ciliary Dyskinesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D002925', 'term': 'Ciliary Motility Disorders'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D000072661', 'term': 'Ciliopathies'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-31', 'studyFirstSubmitDate': '2018-04-04', 'studyFirstSubmitQcDate': '2018-04-04', 'lastUpdatePostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of bacterial colonization of the upper and lower airway', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'bacteriological concordance', 'timeFrame': '1 day', 'description': 'bacteriological concordance of upper airways (VAS) and lower (VAI) between patients with cystic fibrosis and those with primary ciliary dyskinesia.'}, {'measure': 'bacteria genotype', 'timeFrame': '1 day', 'description': 'Compare the genotype of bacteria present in both VAS and VAI.'}, {'measure': 'bacteriological concordance in children', 'timeFrame': '1 day', 'description': 'Subgroup analysis (group \\<18 years old)'}, {'measure': 'bacteriological concordance in adult', 'timeFrame': '1 day', 'description': 'Subgroup analysis (adult group)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis', 'Primary Ciliary Dyskinesia']}, 'referencesModule': {'references': [{'pmid': '12958283', 'type': 'BACKGROUND', 'citation': 'Kahl BC, Duebbers A, Lubritz G, Haeberle J, Koch HG, Ritzerfeld B, Reilly M, Harms E, Proctor RA, Herrmann M, Peters G. Population dynamics of persistent Staphylococcus aureus isolated from the airways of cystic fibrosis patients during a 6-year prospective study. J Clin Microbiol. 2003 Sep;41(9):4424-7. doi: 10.1128/JCM.41.9.4424-4427.2003.'}, {'pmid': '8860069', 'type': 'BACKGROUND', 'citation': 'Frederiksen B, Lanng S, Koch C, Hoiby N. Improved survival in the Danish center-treated cystic fibrosis patients: results of aggressive treatment. Pediatr Pulmonol. 1996 Mar;21(3):153-8. doi: 10.1002/(SICI)1099-0496(199603)21:33.0.CO;2-R.'}, {'pmid': '24210900', 'type': 'BACKGROUND', 'citation': 'Berkhout MC, van Rooden CJ, Rijntjes E, Fokkens WJ, el Bouazzaoui LH, Heijerman HG. Sinonasal manifestations of cystic fibrosis: a correlation between genotype and phenotype? J Cyst Fibros. 2014 Jul;13(4):442-8. doi: 10.1016/j.jcf.2013.10.011. Epub 2013 Nov 5.'}, {'pmid': '27049043', 'type': 'BACKGROUND', 'citation': 'Berkhout MC, Klerx-Melis F, Fokkens WJ, Nuijsink M, van Aalderen WM, Heijerman HG. CT-abnormalities, bacteriology and symptoms of sinonasal disease in children with Cystic Fibrosis. J Cyst Fibros. 2016 Nov;15(6):816-824. doi: 10.1016/j.jcf.2016.03.004. Epub 2016 Apr 3.'}, {'pmid': '17261614', 'type': 'BACKGROUND', 'citation': 'Jelsbak L, Johansen HK, Frost AL, Thogersen R, Thomsen LE, Ciofu O, Yang L, Haagensen JA, Hoiby N, Molin S. Molecular epidemiology and dynamics of Pseudomonas aeruginosa populations in lungs of cystic fibrosis patients. Infect Immun. 2007 May;75(5):2214-24. doi: 10.1128/IAI.01282-06. Epub 2007 Jan 29.'}, {'pmid': '19282318', 'type': 'BACKGROUND', 'citation': 'Mainz JG, Naehrlich L, Schien M, Kading M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tummler B. Concordant genotype of upper and lower airways P aeruginosa and S aureus isolates in cystic fibrosis. Thorax. 2009 Jun;64(6):535-40. doi: 10.1136/thx.2008.104711. Epub 2009 Mar 11.'}, {'pmid': '23357546', 'type': 'BACKGROUND', 'citation': 'Berkhout MC, Rijntjes E, El Bouazzaoui LH, Fokkens WJ, Brimicombe RW, Heijerman HG. Importance of bacteriology in upper airways of patients with Cystic Fibrosis. J Cyst Fibros. 2013 Sep;12(5):525-9. doi: 10.1016/j.jcf.2013.01.002. Epub 2013 Jan 26.'}, {'pmid': '22819141', 'type': 'BACKGROUND', 'citation': 'Aanaes K, Johansen HK, Poulsen SS, Pressler T, Buchwald C, Hoiby N. Secretory IgA as a diagnostic tool for Pseudomonas aeruginosa respiratory colonization. J Cyst Fibros. 2013 Jan;12(1):81-7. doi: 10.1016/j.jcf.2012.07.001. Epub 2012 Jul 20.'}, {'pmid': '24464968', 'type': 'BACKGROUND', 'citation': 'Fischer N, Hentschel J, Markert UR, Keller PM, Pletz MW, Mainz JG. Non-invasive assessment of upper and lower airway infection and inflammation in CF patients. Pediatr Pulmonol. 2014 Nov;49(11):1065-75. doi: 10.1002/ppul.22982. Epub 2014 Jan 25.'}, {'pmid': '24064077', 'type': 'BACKGROUND', 'citation': 'Aanaes K. Bacterial sinusitis can be a focus for initial lung colonisation and chronic lung infection in patients with cystic fibrosis. J Cyst Fibros. 2013 Sep;12 Suppl 2:S1-20. doi: 10.1016/S1569-1993(13)00150-1.'}, {'pmid': '22570319', 'type': 'BACKGROUND', 'citation': 'Magnin ML, Cros P, Beydon N, Mahloul M, Tamalet A, Escudier E, Clement A, Le Pointe HD, Blanchon S. Longitudinal lung function and structural changes in children with primary ciliary dyskinesia. Pediatr Pulmonol. 2012 Aug;47(8):816-25. doi: 10.1002/ppul.22577. Epub 2012 May 8.'}, {'pmid': '26341913', 'type': 'BACKGROUND', 'citation': 'Alanin MC, Nielsen KG, von Buchwald C, Skov M, Aanaes K, Hoiby N, Johansen HK. A longitudinal study of lung bacterial pathogens in patients with primary ciliary dyskinesia. Clin Microbiol Infect. 2015 Dec;21(12):1093.e1-7. doi: 10.1016/j.cmi.2015.08.020. Epub 2015 Sep 2.'}, {'pmid': '25370419', 'type': 'BACKGROUND', 'citation': 'Alanin MC, Johansen HK, Aanaes K, Hoiby N, Pressler T, Skov M, Nielsen KG, von Buchwald C. Simultaneous sinus and lung infections in patients with primary ciliary dyskinesia. Acta Otolaryngol. 2015 Jan;135(1):58-63. doi: 10.3109/00016489.2014.962185. Epub 2014 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'Cytobacteriological examination of sputum and bacteriological sampling in the middle meatus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The protocol will be proposed to the patients followed in the CHI creteil with cystic fibrosis and primary ciliary dyskinesia. Patients should be followed by a lung specialist and ENT specialist and follow the inclusion/exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 6 years old\n* Patients with cystic fibrosis or primary ciliary dyskinesia.\n* Patients capable of performing an expectorations\n* Patients having been informed of the research, having received the information note and not having opposed the research\n\nExclusion Criteria:\n\n\\- Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT03494894', 'acronym': 'BAVASI', 'briefTitle': 'Bacteriological Link Between Upper and Lower Airways in Cystic Fibrosis and Primary Ciliary Dyskinesia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Bacteriological Link Between Upper and Lower Airways in Cystic Fibrosis and Primary Ciliary Dyskinesia', 'orgStudyIdInfo': {'id': 'BAVASI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with Cystic Fibrosis and Primary Ciliary Dyskinesia', 'interventionNames': ['Diagnostic Test: Middle meatus aspirations and sputum']}], 'interventions': [{'name': 'Middle meatus aspirations and sputum', 'type': 'DIAGNOSTIC_TEST', 'description': 'Bacterial genotype sequencing analysis will be performed in patients with bacteriological concordance between upper and lower airways.', 'armGroupLabels': ['patients with Cystic Fibrosis and Primary Ciliary Dyskinesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal de Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}