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Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis (BEACH)

Primary Purpose

Cystic Fibrosis

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
collection of expectoration, stools and blood
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cystic Fibrosis

Eligibility Criteria

2 Months - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Infants aged 6 months maximum at inclusion with a confirmed diagnosis of cystic fibrosis in its classical form (positive sweat test and/or two mutations of the CFTR gene from class I to III)
  • Children free from any antecedent of colonization to P. aeruginosa at the time of inclusion (certified by the microbiological history supplemented by a molecular test by qPCR according to the diagram of Le gal et al., 2013)-Affiliation to the social security system
  • Consent signed by the holders of parental authority or the sole parent holding parental authority / and "oral" agreement of the second holder

Exclusion criteria:

  • Severe acute pathology (other than cystic fibrosis) in progress, or requiring surgery
  • Children unable to undergo the tests required for the Protocol
  • Children whose parent (s) is (are) minor (s)
  • Children whose parental authority does not master the French language
  • Refusal to participate in the study

Sites / Locations

  • CHRU Angers
  • Hôpital des Enfants Bordeaux
  • CHU Grenoble
  • Hôpital Femme-Mère-Enfant Lyon
  • CHRU Nantes
  • Hôpital Necker
  • Hôpital Trousseau
  • CHRU Rennes
  • Centre de Perharidy
  • Hôpital Charles Nicolle Rouen
  • CHRU de Tours

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

collection of expectoration, stools and blood

Arm Description

Outcomes

Primary Outcome Measures

Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age

Secondary Outcome Measures

Absolute amount of P. aeruginosa at different sampling times.
Absolute amount of P. catoniae in respiratory secretions at different sampling times and Delta between 12, 24 and 36 months.
Absolute amount of P. catoniae in stool at different sampling times and Delta between 12, 24 and 36 months.
Level of dysbiosis

Full Information

First Posted
May 10, 2019
Last Updated
July 20, 2023
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT03947957
Brief Title
Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis
Acronym
BEACH
Official Title
Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate the predictive nature of the biomarker Porphyromonas catoniae measured at the age of 12 months in the occurrence of colonization with Pseudomonas aeruginosa at 36 months of age in children with cystic fibrosis.
Detailed Description
This is a multicentric study in 3 phases: Pre-inclusion: at the first visit to the CRCM (support for a positive screening confirmed by sweat test and genotyping CFTR) Inclusion: possible between the 2nd visit to the CRCM (about 2 months old) and the 6th month Follow-up: up to 36 months old. The pace of visits will be based on the usual follow-up rate of CF infants The clinical data as well as samples (expectorations, stools) will be collected on a monthly basis up to 6 months old and then every 2 months until one year old and finally quarterly until 3 years old. Tracheo-bronchial secretions will be collected at the CRCM Stools samples will be carried out by the parents prior to consultation with the CRCM A blood collection will be carried out annually in an annual report.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Infants will be included between the 2nd visit to the CRCM (about 2 months of age) and the 6th month then they will be followed until the age of 36 months. The pace of visits will be based on the usual follow-up rate of CF infants.
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
collection of expectoration, stools and blood
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
collection of expectoration, stools and blood
Intervention Description
collection of expectoration, stools and blood
Primary Outcome Measure Information:
Title
Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Absolute amount of P. aeruginosa at different sampling times.
Time Frame
36 months
Title
Absolute amount of P. catoniae in respiratory secretions at different sampling times and Delta between 12, 24 and 36 months.
Time Frame
36 months
Title
Absolute amount of P. catoniae in stool at different sampling times and Delta between 12, 24 and 36 months.
Time Frame
36 months
Title
Level of dysbiosis
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Infants aged 6 months maximum at inclusion with a confirmed diagnosis of cystic fibrosis in its classical form (positive sweat test and/or two mutations of the CFTR gene from class I to III) Children free from any antecedent of colonization to P. aeruginosa at the time of inclusion (certified by the microbiological history supplemented by a molecular test by qPCR according to the diagram of Le gal et al., 2013)-Affiliation to the social security system Consent signed by the holders of parental authority or the sole parent holding parental authority / and "oral" agreement of the second holder Exclusion criteria: Severe acute pathology (other than cystic fibrosis) in progress, or requiring surgery Children unable to undergo the tests required for the Protocol Children whose parent (s) is (are) minor (s) Children whose parental authority does not master the French language Refusal to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Genevieve HERY-ARNAUD, Pr
Organizational Affiliation
University Hospital, Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Angers
City
Angers
Country
France
Facility Name
Hôpital des Enfants Bordeaux
City
Bordeaux
Country
France
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Facility Name
Hôpital Femme-Mère-Enfant Lyon
City
Lyon
Country
France
Facility Name
CHRU Nantes
City
Nantes
Country
France
Facility Name
Hôpital Necker
City
Paris
Country
France
Facility Name
Hôpital Trousseau
City
Paris
Country
France
Facility Name
CHRU Rennes
City
Rennes
Country
France
Facility Name
Centre de Perharidy
City
Roscoff
Country
France
Facility Name
Hôpital Charles Nicolle Rouen
City
Rouen
Country
France
Facility Name
CHRU de Tours
City
Tours
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Learn more about this trial

Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis

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