Bacteriological Link Between Upper and Lower Airways in Cystic Fibrosis and Primary Ciliary Dyskinesia

NCT ID: NCT03494894

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2019-02-19

Brief Summary

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Cytobacteriological examination of sputum and bacteriological sampling in the middle meatus.

Detailed Description

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Conditions

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Cystic Fibrosis Primary Ciliary Dyskinesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with Cystic Fibrosis and Primary Ciliary Dyskinesia

Middle meatus aspirations and sputum

Intervention Type DIAGNOSTIC_TEST

Bacterial genotype sequencing analysis will be performed in patients with bacteriological concordance between upper and lower airways.

Interventions

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Middle meatus aspirations and sputum

Bacterial genotype sequencing analysis will be performed in patients with bacteriological concordance between upper and lower airways.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients over 6 years old
* Patients with cystic fibrosis or primary ciliary dyskinesia.
* Patients capable of performing an expectorations
* Patients having been informed of the research, having received the information note and not having opposed the research

Exclusion Criteria

\- Refusal to participate in the study
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Intercommunal de Créteil

Créteil, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 12958283 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8860069 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24210900 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27049043 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17261614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19282318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23357546 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22819141 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24464968 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24064077 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22570319 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26341913 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25370419 (View on PubMed)

Other Identifiers

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BAVASI

Identifier Type: -

Identifier Source: org_study_id

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