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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494894
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

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

Condition or disease Intervention/treatment
Cystic Fibrosis Primary Ciliary Dyskinesia Diagnostic Test: Middle meatus aspirations and sputum

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bacteriological Link Between Upper and Lower Airways in Cystic Fibrosis and Primary Ciliary Dyskinesia
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : June 14, 2017
Actual Study Completion Date : February 19, 2019


Group/Cohort Intervention/treatment
patients with Cystic Fibrosis and Primary Ciliary Dyskinesia Diagnostic Test: Middle meatus aspirations and sputum
Bacterial genotype sequencing analysis will be performed in patients with bacteriological concordance between upper and lower airways.




Primary Outcome Measures :
  1. Presence of bacterial colonization of the upper and lower airway [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. bacteriological concordance [ Time Frame: 1 day ]
    bacteriological concordance of upper airways (VAS) and lower (VAI) between patients with cystic fibrosis and those with primary ciliary dyskinesia.

  2. bacteria genotype [ Time Frame: 1 day ]
    Compare the genotype of bacteria present in both VAS and VAI.

  3. bacteriological concordance in children [ Time Frame: 1 day ]
    Subgroup analysis (group <18 years old)

  4. bacteriological concordance in adult [ Time Frame: 1 day ]
    Subgroup analysis (adult group)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494894


Locations
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France
Centre Hospitalier Intercommunal de Créteil
Créteil, France, 94000
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Publications:

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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03494894    
Other Study ID Numbers: BAVASI
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Ciliary Motility Disorders
Dyskinesias
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Ciliopathies
Abnormalities, Multiple
Congenital Abnormalities