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

NCT03910920 | Unknown

• 1 other identifier: P2018/PNEUMO/PAPED
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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…).

Conditions

Cystic Fibrosis; Pseudomonas Aeruginosa; Cross Infection

Outcome Measures

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)

  through study completion

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• None

Sponsors & Collaborators

• Queen Fabiola Children's University Hospital: lead
• Centre National de Référence S.aureus: collaborator

Study Sites (1)

Hôpital Universitaire Des Enfants Reine Fabiola

Brussels, 1020, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

Respiratory secretions

MeSH Terms

Conditions

Cystic Fibrosis; Pseudomonas Infections; Cross Infection

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Christophe Beghin, MD

  HUDERF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: April 10, 2019
• Study Start: February 6, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: April 10, 2019

Record last verified: 2019-03

Locations

BE (1)