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

Cystic Fibrosis Clinical Trial

— PAPED  

Official title:

Cross Transmissions of Pseudomonas Aeruginosa in a Pediatric Cohort Followed-up at the Cystic Fibrosis Reference Center of the Queen Fabiola Children's University Hospital.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03910920
• Other study ID #: P2018/PNEUMO/PAPED
• Status: Enrolling by invitation
• Start date: February 6, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: March 2019
• Source: Queen Fabiola Children's University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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…).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Years

Eligibility

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:

Related Conditions & MeSH terms

• Cross Infection
• Cystic Fibrosis
• Fibrosis
• Pseudomonas Aeruginosa
• Pseudomonas Infections

Locations

Country	Name	City	State
Belgium	Hôpital Universitaire Des Enfants Reine Fabiola	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Queen Fabiola Children's University Hospital	Centre National de Référence S.aureus

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	through study completion