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

Cystic Fibrosis Clinical Trial

— BAVASI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03494894
• Other study ID #: BAVASI
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: February 19, 2019

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 19, 2019
• Est. primary completion date: June 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ciliary Motility Disorders
• Cystic Fibrosis
• Dyskinesias
• Fibrosis
• Primary Ciliary Dyskinesia

Intervention

Diagnostic Test:
• Middle meatus aspirations and sputum
Bacterial genotype sequencing analysis will be performed in patients with bacteriological concordance between upper and lower airways.

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Créteil	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

References & Publications (13)

Aanaes K, Johansen HK, Poulsen SS, Pressler T, Buchwald C, Høiby 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. Erratum in: J Cyst Fibros. 2013 Dec;12(6):830. — View Citation

Aanæs 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. — View Citation

Alanin MC, Johansen HK, Aanaes K, Høiby 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. — View Citation

Alanin MC, Nielsen KG, von Buchwald C, Skov M, Aanaes K, Høiby 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Frederiksen B, Lanng S, Koch C, Høiby N. Improved survival in the Danish center-treated cystic fibrosis patients: results of aggressive treatment. Pediatr Pulmonol. 1996 Mar;21(3):153-8. — View Citation

Jelsbak L, Johansen HK, Frost AL, Thøgersen R, Thomsen LE, Ciofu O, Yang L, Haagensen JA, Høiby 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. Epub 2007 Jan 29. — View 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. — View Citation

Magnin ML, Cros P, Beydon N, Mahloul M, Tamalet A, Escudier E, Clément 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. — View Citation

Mainz JG, Naehrlich L, Schien M, Käding M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tümmler 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of bacterial colonization of the upper and lower airway		1 day
Secondary	bacteriological concordance	bacteriological concordance of upper airways (VAS) and lower (VAI) between patients with cystic fibrosis and those with primary ciliary dyskinesia.	1 day
Secondary	bacteria genotype	Compare the genotype of bacteria present in both VAS and VAI.	1 day
Secondary	bacteriological concordance in children	Subgroup analysis (group <18 years old)	1 day
Secondary	bacteriological concordance in adult	Subgroup analysis (adult group)	1 day