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

July 31, 2020 updated by: Centre Hospitalier Intercommunal Creteil
Cytobacteriological examination of sputum and bacteriological sampling in the middle meatus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France, 94000
        • Centre Hospitalier Intercommunal de Créteil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of bacterial colonization of the upper and lower airway
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
bacteria genotype
Time Frame: 1 day
Compare the genotype of bacteria present in both VAS and VAI.
1 day
bacteriological concordance in children
Time Frame: 1 day
Subgroup analysis (group <18 years old)
1 day
bacteriological concordance in adult
Time Frame: 1 day
Subgroup analysis (adult group)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

June 14, 2017

Study Completion (ACTUAL)

February 19, 2019

Study Registration Dates

First Submitted

April 4, 2018

First Submitted That Met QC Criteria

April 4, 2018

First Posted (ACTUAL)

April 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2020

Last Update Submitted That Met QC Criteria

July 31, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAVASI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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