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| Sponsors and Collaborators: |
University of Florence Italian Cystic Fibrosis Research Foundation, Verona, Italy Meyer Pediatric Hospital, Florence, Italy |
|---|---|
| Information provided by: | University of Florence |
| ClinicalTrials.gov Identifier: | NCT00531531 |
Purpose
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.
| Condition |
|---|
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Cystic Fibrosis |
| Study Type: | Observational |
| Study Design: | Cohort, Cross-Sectional |
| Official Title: | Control and Prevention of Respiratory Infections in Cystic Fibrosis Patients: an Evaluation of the Emission Distance of P. Aeruginosa From the Respiratory Tract of Infected Persons Through Coughing and Conversation. |
| Enrollment: | 42 |
| Study Start Date: | September 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 14 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
People with CF attending the CF Center of Tuscany, aged 14 or older, with documented pulmonary Pseudomnas aeruginosa infection.
Inclusion Criteria:
Contacts and Locations| Italy | |
| Cystic Fibrosis Center of Tuscany, Meyer Hospital | |
| Florence, Italy, 50132 | |
| Study Chair: | Filippo Festini, BN, BSN, RN | University of Florence, Italy |
| Study Director: | Cesare Braggion, MD | Cystic Fibrosis Center, Meyer Hospital Florence |
More Information
| Responsible Party: | University of Florence ( Filippo Festini ) |
| Study ID Numbers: | FFC#16/2007 |
| Study First Received: | September 18, 2007 |
| Last Updated: | August 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00531531 |
| Health Authority: | Italy: Ethics Committee |
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pulmonary infection transmission P.Aeruginosa surfaces |
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Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Respiratory Tract Infections Fibrosis |
Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Cough Cystic fibrosis |
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Pathologic Processes |
