NCT03947957

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Oct 2020Jul 2026

First Submitted

Initial submission to the registry

May 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 2, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

5.7 years

First QC Date

May 10, 2019

Last Update Submit

February 19, 2026

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

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

    positive or negative

    36 months

Secondary Outcomes (11)

  • Absolute amount of P. aeruginosa at different sampling times.

    36 months

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

    36 months

  • Absolute amount of P. catoniae in stool at different sampling times and Delta between 12, 24 and 36 months.

    36 months

  • Level of dysbiosis

    36 months

  • Pulmonary concentration of inflammatory markers

    36 months

  • +6 more secondary outcomes

Study Arms (1)

collection of expectoration, stools and blood

OTHER
Diagnostic Test: collection of expectoration, stools and blood

Interventions

collection of expectoration, stools and bloodDIAGNOSTIC_TEST

collection of expectoration, stools and blood

collection of expectoration, stools and blood

Eligibility Criteria

Age2 Months - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Severe acute illness (other than cystic fibrosis) ongoing, or requiring surgery
  • Children unable to undergo the tests required by the protocol
  • Children whose parent(s) is/are minors
  • Children whose legal guardians do not have sufficient command of the French language
  • Children under exclusive parenteral nutrition
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CHRU Angers

Angers, France

Location

Hôpital des Enfants Bordeaux

Bordeaux, France

Location

CHU Grenoble

Grenoble, France

Location

Hôpital Femme-Mère-Enfant Lyon

Lyon, France

Location

CHRU Nantes

Nantes, France

Location

Hôpital Necker

Paris, France

Location

Hôpital Trousseau

Paris, France

Location

CHRU Rennes

Rennes, France

Location

Centre de Perharidy

Roscoff, France

Location

Hôpital Charles Nicolle

Rouen, France

Location

CHRU de Tours

Tours, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

DefecationBlood Specimen Collection

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological PhenomenaDigestive System and Oral Physiological PhenomenaSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Genevieve HERY-ARNAUD, Pr

    University Hospital, Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 13, 2019

Study Start

October 2, 2020

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
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.

Locations

FR(11)