NCT03910920: PAPED

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

Status unknown Last updated 10 April 2019

What this trial tests

trial in Cystic Fibrosis in 15 participants. Status unknown.

Timeline

6 February 2019

Primary endpoint
31 January 2021

31 January 2021

Quick facts

Lead sponsor	Queen Fabiola Children's University Hospital
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	15
Start date	6 February 2019
Primary completion	31 January 2021
Estimated completion	31 January 2021
Sites	1 location across Belgium

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →
• Pseudomonas Aeruginosa — all drugs for Pseudomonas Aeruginosa →
• Cross Infection — all drugs for Cross Infection →

Sponsor

Queen Fabiola Children's University Hospital

Who can join

Under 20, any sex, with Cystic Fibrosis or Pseudomonas Aeruginosa. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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…).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.