We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03947957 | Cystic Fibrosis
Previous Study | Return to List | Next Study

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03947957
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 24 months of age in children with cystic fibrosis.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Diagnostic Test: collection of expectoration, stools and blood Not Applicable

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 24 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 2 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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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 24 months. The pace of visits will be based on the usual follow-up rate of CF infants.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis
Actual Study Start Date : October 2, 2020
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
collection of expectoration, stools and blood Diagnostic Test: collection of expectoration, stools and blood
collection of expectoration, stools and blood


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Presence of P. aeruginosa in bacterial sputum cultures collected at 24 months of age [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Absolute amount of P. aeruginosa at different sampling times. [ Time Frame: 24 months ]
  2. Absolute amount of P. catoniae in respiratory secretions at different sampling times and Delta between 12 and 24 months. [ Time Frame: 24 months ]
  3. Absolute amount of P. catoniae in stool at different sampling times and Delta between 12 and 24 months. [ Time Frame: 24 months ]
  4. Level of dysbiosis [ Time Frame: 24 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03947957


Contacts
Layout table for location contacts
Contact: Genevieve HERY-ARNAUD, Pr +33 2 98 14 51 02 genevieve.hery-arnaud@chu-brest.fr

Locations
Layout table for location information
France
CHRU Angers Recruiting
Angers, France
Contact: Francoise TROUSSIER, Dr         
Principal Investigator: Francosie TROUSSIER, Dr         
Hôpital des Enfants Bordeaux Recruiting
Bordeaux, France
Contact: Stéphanie BUI         
CHU Grenoble Recruiting
Grenoble, France
Contact: Sophie VALOIS       SValois@chu-grenoble.fr   
Hôpital Femme-Mère-Enfant Lyon Recruiting
Lyon, France
Contact: Philippe REIX         
CHRU Nantes Recruiting
Nantes, France
Contact: Tiphaine BIHOUEE, Dr         
Principal Investigator: Tiphaine BIHOUEE, Dr         
Hôpital Necker Not yet recruiting
Paris, France
Contact: Isabelle SERMET-GAUDELUS         
Hôpital Trousseau Not yet recruiting
Paris, France
Contact: Harriet CORVOL         
CHRU Rennes Recruiting
Rennes, France
Contact: Eric DENEUVILLE, Dr         
Principal Investigator: Eric DENEUVILLE, Dr         
Centre de Perharidy Not yet recruiting
Roscoff, France
Contact: Audrey BARZIC, Dr       audrey.barzic@ildys.org   
Principal Investigator: Audrey BARZIC, Dr         
Hôpital Charles Nicolle Rouen Recruiting
Rouen, France
Contact: Christophe MARGUET         
CHRU de Tours Recruiting
Tours, France
Contact: Laure COSSON, Dr         
Principal Investigator: Laure COSSON, Dr         
Sponsors and Collaborators
University Hospital, Brest
Investigators
Layout table for investigator information
Principal Investigator: Genevieve HERY-ARNAUD, Pr University Hospital, Brest
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03947957    
Other Study ID Numbers: BEACH (29BRC19.0065)
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases