CClinicalTrials.gg
Status unknownNCT03910920PAPEDUpdated Apr 10, 2019

Cross Transmissions of Pseudomonas Aeruginosa Between Children From a Same Cystic Fibrosis Center.

An observational study in Cystic Fibrosis, Pseudomonas Aeruginosa and Cross Infection, sponsored by Queen Fabiola Children's University Hospital. Status unknown at 1 site in Belgium. Open to participants aged Up to 20 Years. Per ClinicalTrials.gov, last updated 2019-04-10.

Sponsored by Queen Fabiola Children's University Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
Up to 20 Years
Sex
All
01

Study summary

Cystic fibrosis is the most common hereditary autosomal recessive disease in the Caucasian population. The diseases is caused by a mutation of the gene coding for the CFTR protein (Cystic fibrosis transmembrane conductance regulator), an ion channel present at the apical pole of the epithelial cells. The channel dysfunction induces a deficit in hydration and a hyperviscosity of different exocrine secretions.

Clinically, Cystic fibrosis is a multi-systemic disease. Pulmonary and pancreatic involvement are classically in the foreground. Degradation of respiratory function, associated with acute and chronic infections, represents the major cause of morbidity and mortality.

Pseudomonas aeruginosa is a ubiquitous gram-negative bacillus found primarily in stagnant water. Pseudomonas aeruginosa is capable of colonizing the digestive, pulmonary and urinary mucosa and the skin. This bacterium is incriminated in many opportunistic infections including respiratory infections in patients with cystic fibrosis. Pseudomonas aeruginosa infection is the most common parenchymal lung infection in the Cystic fibrosis community.

Pseudomonas aeruginosa chronic carriage represents a factor of poor prognosis associated with an increase in morbidity and mortality. Complications related to chronic carriage of Pseudomonas aeruginosa justify the implementation of strategies of eviction, screening and eradication of acute Pseudomonas aeruginosa infection.

In addition to Pseudomonas aeruginosa contamination of patients via the environment, hand and airborne infections between patients with Cystic fibrosis have been reported. Measures to eliminate cross-transmissions have therefore been implemented in a majority of hospitals.

The aim of the study is firstly to identify the number of Pseudomonas aeruginosa cross-transmissions between patients with Cystic fibrosis followed-up in Cystic fibrosis center of HUDERF. Investigator will use the Pulsed-Field Gel Electrophoresis to assess the possibility of cross-infection.

Depending on the results, Investigator will implement new strategies to avoid future cross-contamination in our different places of care (consultation, hospitalization, physiotherapy...).

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Conditions studied

  • Cystic Fibrosis
  • Pseudomonas Aeruginosa
  • Cross Infection
03

In context

Pseudomonas Infections

97 studies on the registry are indexed under Pseudomonas Infections; 23 are open to participants now.

This study's planned enrollment of 15 is below the median of 100 across 32 observational studies indexed under Pseudomonas Infections.

Browse Pseudomonas Infections studies →

Lead sponsor

Queen Fabiola Children's University Hospital is the lead sponsor of 28 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cystic fibrosis patients followed-up in cystic fibrosis center in Brussels.

Inclusion criteria

  • Cystic fibrosis patients aged 0-20y followed in Cystic fibrosis at HUDERF
  • For each participant, both parents or legally acceptable representative(s) must sign an informed consent form (ICF) indicating that they understand the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study.
  • Assent is also required of children capable of understanding the study (typically participants 7 years of age and older).

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cystic fibrosis patients with PA

    All the children with acute or chronic Pseudomonas aeruginosa infection and followed-up in our cystic fibrosis center will be included in this study.

06

What researchers measure

Primary outcomes

  1. Identification of Pseudomonas cross infections between cystic fiborsis patients

    Highlighting common strains (similar typing) of Pseudomonas aeruginosa in respiratory secretion using the PFGE (Pulsed-field Gel Electrophoresis)

    Time frame: through study completion

07

Study locations

1 site
  • Hôpital Universitaire Des Enfants Reine Fabiola
    Brussels, 1020, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03910920
Lead sponsor
Queen Fabiola Children's University Hospital
Collaborators
Centre National de Référence S.aureus
Responsible party
Sponsor
First posted
Apr 10, 2019
Start date
Feb 6, 2019
Primary completion
Jan 31, 2021 (estimated)
Completion
Jan 31, 2021 (estimated)
Last update
Apr 10, 2019

Study contacts

Jean-Christophe Beghin, MD
principal investigator · HUDERF

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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