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

Cystic Fibrosis Clinical Trial

— BEACH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03947957
• Other study ID #: BEACH (29BRC19.0065)
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: July 2026

Study information

• Verified date: April 2024
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Diagnostic Test:
• collection of expectoration, stools and blood
collection of expectoration, stools and blood

Locations

Country	Name	City	State
France	CHRU Angers	Angers
France	Hôpital des Enfants Bordeaux	Bordeaux
France	CHU Grenoble	Grenoble
France	Hôpital Femme-Mère-Enfant Lyon	Lyon
France	CHRU Nantes	Nantes
France	Hôpital Necker	Paris
France	Hôpital Trousseau	Paris
France	CHRU Rennes	Rennes
France	Centre de Perharidy	Roscoff
France	Hôpital Charles Nicolle Rouen	Rouen
France	CHRU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age	positive or negative	36 months
Secondary	Absolute amount of P. aeruginosa at different sampling times.	amount (UFC/mL)	36 months
Secondary	Absolute amount of P. catoniae in respiratory secretions at different sampling times and Delta between 12, 24 and 36 months.	amount (UFC/mL)	36 months
Secondary	Absolute amount of P. catoniae in stool at different sampling times and Delta between 12, 24 and 36 months.	amount (UFC/mL)	36 months
Secondary	Level of dysbiosis		36 months