NCT03947957Active, not recruiting
Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 10 May 2019
- Start date
- 2 Oct 2020
- Primary completion date
- Nov 2026
- Lead sponsor
- University Hospital, Brest
- Diseases
- Cystic fibrosis
- NCT number
- NCT03947957
What you commit to
- Study type: Interventional
- Participants enrolled: 70
- From 2 Oct 2020 to the primary completion date, Nov 2026
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe acute illness (other than cystic fibrosis) ongoing, or requiring surgery
Other
- 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
Who the study is looking for
- 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
Age in the registry: 2 months to 6 months · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chru Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Hôpital des Enfants Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Chu Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Hôpital Femme-Mère-Enfant Lyon Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| CHRU Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Hôpital Necker Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Trousseau Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHRU Rennes Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Centre de Perharidy Coordinator of this site? Confirm its status | Roscoff | France | Unknown status |
| Hôpital Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| CHRU de Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.