Evaluation of the Emission Distance of P. Aeruginosa From the Respiratory Tract of People With Cystic Fibrosis

NCT00531531 | Completed

• 1 other identifier: FFC#16/2007
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

It is well known that an association exists between the acquisition of some respiratory pathogens and prognosis of CF people. About 57 % of patients has a lung infection due to P.aeruginosa (PA). Transmission of PA between CF patients is possible and several prevention measures are recommended. Among these measures, all international guidelines recommend that CF people maintain a minimum distance of 1 meter between them. However, this recommendation is not supported by specific studies and scientific evidence. In other words, the investigators don't know if this measure is sufficient or excessive, as it is based only on a theoretical rationale. This study aims at measuring experimentally the distance that can be reached by PA emitted from airways of colonized CF patients during cough and during conversation. To this purpose, the investigators will evacuate the presence of PA on surfaces placed at 4 different distances from patients, through the collection of 8 swabs, 4 of which following cough and 4 following conversation. Swabs will be collected on sterile surfaces comprised between tra 0 - 0,5 mt; 0,5 -1,00 mt.; 1,00 - 1,5 mt and 1.5-2 mt. All the PA-positive CF patients of the CF Centre of Tuscany aged 14 or more will be recruited.

Conditions

Cystic Fibrosis

Keywords

pulmonary infection; transmission; P.Aeruginosa; surfaces

Outcome Measures

Primary Outcomes (1)

• Prevalence of surface samples positive for PA

  six months

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

People with CF attending the CF Center of Tuscany, aged 14 or older, with documented pulmonary Pseudomnas aeruginosa infection.

You may qualify if:

• Diagnosis of CF
• Age 14 or older.
• PA infection documented by the most recent expectorate culture available, no more than 3 months old.

Sponsors & Collaborators

• University of Florence: lead
• Italian Cystic Fibrosis Research Foundation: collaborator
• Ospedale Meyer: collaborator

Study Sites (1)

Cystic Fibrosis Center of Tuscany, Meyer Hospital

Florence, 50132, Italy

Location

MeSH Terms

Conditions

Cystic Fibrosis

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

Study Officials

• Filippo Festini, BN, BSN, RN

  University of Florence, Italy

  STUDY CHAIR

• Cesare Braggion, MD

  Cystic Fibrosis Center, Meyer Hospital Florence

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 19, 2007
• Study Start: September 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 23, 2011

Record last verified: 2011-08

Locations

IT (1)