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

Not Applicable

Active, not recruiting

• Conditions: Cystic Fibrosis
• Interventions: Diagnostic Test: collection of expectoration, stools and blood

• Registration Number: NCT03947957
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-13
• Study Start: 2020-10-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
collection of expectoration, stools and blood	collection of expectoration, stools and blood	-

Primary Outcome Measures

Name	Time	Method
Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age	36 months	positive or negative

Secondary Outcome Measures

Name	Time	Method
Absolute amount of P. aeruginosa at different sampling times.	36 months	amount (UFC/mL)
Level of dysbiosis	36 months
Absolute amount of P. catoniae in respiratory secretions at different sampling times and Delta between 12, 24 and 36 months.	36 months	amount (UFC/mL)
Absolute amount of P. catoniae in stool at different sampling times and Delta between 12, 24 and 36 months.	36 months	amount (UFC/mL)

Trial Locations

Locations (11)

CHRU Angers; 🇫🇷 Angers, France

CHU Grenoble; 🇫🇷 Grenoble, France

Hôpital Femme-Mère-Enfant Lyon; 🇫🇷 Lyon, France

CHRU Nantes; 🇫🇷 Nantes, France

Hôpital Necker; 🇫🇷 Paris, France

Hôpital Trousseau; 🇫🇷 Paris, France

Hôpital Charles Nicolle Rouen; 🇫🇷 Rouen, France

CHRU de Tours; 🇫🇷 Tours, France

Hôpital des Enfants Bordeaux; 🇫🇷 Bordeaux, France

CHRU Rennes; 🇫🇷 Rennes, France

Centre de Perharidy; 🇫🇷 Roscoff, France