Ignite Creation Date:
2024-05-05 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00531531
Status:
COMPLETED
Last Update Posted:
2011-08-23
First Post:
2007-09-18
Brief Title:
Evaluation of the Emission Distance of P Aeruginosa From the Respiratory Tract of People With Cystic Fibrosis
Sponsor:
University of Florence
Organization:
University of Florence
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Paeruginosa 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 dont 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 - 05 mt 05 -100 mt 100 - 15 mt and 15-2 mt
All the PA-positive CF patients of the CF Centre of Tuscany aged 14 or more will be recruited
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 - 05 mt 05 -100 mt 100 - 15 mt and 15-2 mt
All the PA-positive CF patients of the CF Centre of Tuscany aged 14 or more will be recruited
Detailed Description:
Background
Cystic Fibrosis CF represents the most frequent genetic disorder with autosomal recessive transmission having a negative prognosis in Caucasian populations with an incidence of about 1 in 3000 CF is a multisystemic disease involving the exocrine functions in particular of the respiratory tract and the gastroenteric system The mutated gene causes an alteration in the transportation of chloride and sodium that leads to the production of denser bronchial secretion favouring the onset of chronic respiratory infections inflammations and respiratory insufficiency Indeed pulmonary infections are one of the primary characteristics as well as the main cause of morbidity and mortality in CF
There is an association between the acquisition of some respiratory pathogens mainly B cepacia complex BCC and P aeruginosa PA and the worsening of the parameters of respiratory function and a lower survival rate
Recent epidemiological data show that 573 of CF patients have a pulmonary infection caused by PA
Therefore to prevent the clinical consequences deriving from chronic colonization of PA avoiding contact with the infected patient when possible can be of fundamental importance
The means by which the patient comes in contact with these pathogens is still not entirely clear nevertheless it is believed that transmission can occur through direct contact or droplets or through indirect contact with inert surfaces used in common by colonized and non-colonized patients or by reservoirs and surfaces in the care environment itself Droplets are defined as large drops 5 microns produced by coughing sneezing or speaking or by the implementing of certain procedures such as aspiration or broncoscopy
As for indirect means of transmission it has been demonstrated that these pathogens have high survival rates on inert surfaces for example PA suspended in physiological solution can survive on dry surfaces for 24 hours and in patient expectoration for 8 days
If expelled with coughing or sneezing from the CF patients respiratory tract therefore PA and BCC 20 can linger on the surfaces of the health care centre for a long time later to enter into contact with the respiratory mucosa of CF patients attending the same centre through contact of the patients hands on contaminated surfaces
Only a limited number of studies has evaluated the prevalence of pathogens on non-critical surfaces in a CF centre
In one recent study our research group evaluated over a 4-year period the prevalence of the pathogenic micro-organisms for CF in specimens taken from non-critical surfaces and sinks of an out-patient clinic dedicated exclusively to the care of CF patients with the aim of improving the prevention of cross-infections in CF centres
As for direct transmission of PA there are various international prevention guidelines All the guidelines include the recommendation that CF patients maintain a minimum distance of 1 meter between one another
A recent study has demonstrated the theoretical possibility of airborne PA transmission
Specific Aims and Rationale According to all international guidelines for controlling and preventing infections in CF patients it is necessary to maintain a minimum distance of 1 meter from other CF patients in order to avoid the transmission of PA and BCC and the clinical consequences of a chronic infection from this pathogen This indication derives from a similar recommendation contained in the CDC Guidelines on hospital isolation precautions relative to all infectious diseases transmitted through droplets It is based on the theoretical assumption that besides transmission by direct contact the transmission of PA takes place prevalently through droplets
There have been only two studies on the distance reached by PA emitted from the respiratory tract of CF patients The first study 18 examined PA emission from CF patients coughing making them cough onto a dish held by the patients themselves then onto a plate held at a distance of about a meter In the second study six PA-colonized patients coughed in the direction of a soap bubble holder held at a distance of 10 cm 20 cm 30 cm 40 cm and 50 cm from the mouth
The results obtained in these two studies have shown the possibility of transmitting PA through coughing at a distance of at least one meter and the possibility of emitting PA at distances greater than 40 cm However these studies do not provide proof that one meter is an effective indicator of the distance necessary for preventing PA emitted by one patient from reaching another
It appears that no study has ever investigated if PA can be expelled from a carriers respiratory tract by coughing at a distance greater than the recommended one meter safety distance between CF patients and no study has been done on the maximum distance PA emitted during a normal conversation can reach
In any case aside from the distance PA can actually reach there are no studies on the effectiveness of a 1-meter distance between CF patients as a measure for preventing PA cross-infections
Since there are very few data available on how far PA emitted from the respiratory tract of a colonized CF patient through coughing can reach and no data relative to simple conversation the recommendation of a one-meter distance does not seem to be backed up by sufficient evidence In other words one meter may not be a great enough distance for preventing the potential risk of transmission therefore the recommendation to maintain a minimum distance of one meter may be inadequate
Our study thus intends to contribute to filling the knowledge gap to this regard and to clarifying the validity of the minimum distance of one meter as a prevention measure in the transmission of PA from one CF patient to another
The objectives in this study are
To evaluate what distance can be reached by PA expelled through the emission of droplets from the respiratory tract of a CF patient during a simple conversation and coughing
To verify if the 1-meter distance from patients colonized by PA is actually an effective prevention measure in regard to PA infection as reported in the International Guidelines
Experimental study not checked with convenience sample This study will evaluate the distance reached by Pseudomonas aeruginosa after a normal conversation and after coughing by CF patients
With this aim we will evaluate the presence of PA on surfaces at 4 different distances from the patient by culturing 8 swabs taken from the surfaces themselves 4 of which after normal conversation and 4 others after coughing
Data collection At the time of inclusion in the study the following data will be collected Patient name and surname age in months Rx score FEV1 BMI Micro-organisms present in the previous and current expectorate culture PCR
After collecting the specimens and preparing the culture plates PA growth in the mediums corresponding to the various collection distances will be observed
The results of the laboratory analysis will be reported in the patients file thus
Presence of Pseudomonas Aeruginosa
after conversation 0 - 05 m 05 - 100 m 100 - 15 m 150 - 200 m
after coughing 0 - 05 m 05 - 100 m 100 - 15 m 150 - 200 m
Safety measures Personnel will wear single-use gloves and coats
Data management and statistical analysis The data will be entered into Microsoft Access 2000 database For each of the four distances and for each of the two modes coughing and conversation the percentage of PA presence will be determined and the confidence intervals will be defined to 95 of the percentages
Moreover we will look for associations between the presenceabsence of PA at each distance and for each of the modes and the clinical variables in each patient
For qualitative variables statistical analysis will be made with Chi-square test For quantitative variables statistical analysis will be done with Students T-distribution
Expected Results
We expect to obtain estimates of the proportion of contaminated areas so as to estimate the CF patient risk of being reached by secretions expelled from the respiratory tract of other CF patients at different distances
Clinical protocols
Recruitment
Upon a patient receiving a check-up at the CF Centre the researcher will decide on the basis of demographics and microbiology if the patient can be included in the study group
If the patient has reached the age of 14 and the last microbiological culture of his expectorate is positive for PA the patient will be asked and his parents if under age to participate in the study and will be given background information After all his questions are answered if the patient decides to participate his written consent will be taken co-signed by his parents if under age Subsequently the patients entry data will be taken by filling out a patient questionnaire after which the specimens will be collected
The study does not call for the assignment of a therapeutic strategy the clinical and laboratory data relative to the patients participating in the study will be obtained during routine follow-up without modifying current clinical practice
Specimen collection methods To collect the specimens a special ruled table 05 X 210 will be set up and covered with a single-use waterproof surgical cloth after the patient has been enlisted in the study
The patient will then be asked to place himself in front of the table at the 0 m point
The table will be regulated according to the patients height at the level of his navel
Then the patient will be asked to read a text placed in front of him out loud in order to recreate a normal conversation
We will then proceed to take the specimens with 4 sterile swabs each one of which will be used for collecting specimens on the table surface subdivided into the following distances 0 - 05 m 05 - 100 m 100 - 15 m 150 - 200 m
Specimen collection with a sterile swab from the surface of the sterile cloth will be done by rubbing entirely each of the four surfaces into which the sterile cloth is subdivided entirely using a boustrophedonic movement
After the first set is collected the single-use cloth will be substituted in order to restore sterile conditions
Next the patient will be asked to perform two FET sequences which consist in giving one or two forced expirations with the glottis open starting with medium-low lung volume followed by a rest period in which diaphragm breathing is maintained At this point the collection of the next 4 specimens will be taken in the method described above
Cystic Fibrosis CF represents the most frequent genetic disorder with autosomal recessive transmission having a negative prognosis in Caucasian populations with an incidence of about 1 in 3000 CF is a multisystemic disease involving the exocrine functions in particular of the respiratory tract and the gastroenteric system The mutated gene causes an alteration in the transportation of chloride and sodium that leads to the production of denser bronchial secretion favouring the onset of chronic respiratory infections inflammations and respiratory insufficiency Indeed pulmonary infections are one of the primary characteristics as well as the main cause of morbidity and mortality in CF
There is an association between the acquisition of some respiratory pathogens mainly B cepacia complex BCC and P aeruginosa PA and the worsening of the parameters of respiratory function and a lower survival rate
Recent epidemiological data show that 573 of CF patients have a pulmonary infection caused by PA
Therefore to prevent the clinical consequences deriving from chronic colonization of PA avoiding contact with the infected patient when possible can be of fundamental importance
The means by which the patient comes in contact with these pathogens is still not entirely clear nevertheless it is believed that transmission can occur through direct contact or droplets or through indirect contact with inert surfaces used in common by colonized and non-colonized patients or by reservoirs and surfaces in the care environment itself Droplets are defined as large drops 5 microns produced by coughing sneezing or speaking or by the implementing of certain procedures such as aspiration or broncoscopy
As for indirect means of transmission it has been demonstrated that these pathogens have high survival rates on inert surfaces for example PA suspended in physiological solution can survive on dry surfaces for 24 hours and in patient expectoration for 8 days
If expelled with coughing or sneezing from the CF patients respiratory tract therefore PA and BCC 20 can linger on the surfaces of the health care centre for a long time later to enter into contact with the respiratory mucosa of CF patients attending the same centre through contact of the patients hands on contaminated surfaces
Only a limited number of studies has evaluated the prevalence of pathogens on non-critical surfaces in a CF centre
In one recent study our research group evaluated over a 4-year period the prevalence of the pathogenic micro-organisms for CF in specimens taken from non-critical surfaces and sinks of an out-patient clinic dedicated exclusively to the care of CF patients with the aim of improving the prevention of cross-infections in CF centres
As for direct transmission of PA there are various international prevention guidelines All the guidelines include the recommendation that CF patients maintain a minimum distance of 1 meter between one another
A recent study has demonstrated the theoretical possibility of airborne PA transmission
Specific Aims and Rationale According to all international guidelines for controlling and preventing infections in CF patients it is necessary to maintain a minimum distance of 1 meter from other CF patients in order to avoid the transmission of PA and BCC and the clinical consequences of a chronic infection from this pathogen This indication derives from a similar recommendation contained in the CDC Guidelines on hospital isolation precautions relative to all infectious diseases transmitted through droplets It is based on the theoretical assumption that besides transmission by direct contact the transmission of PA takes place prevalently through droplets
There have been only two studies on the distance reached by PA emitted from the respiratory tract of CF patients The first study 18 examined PA emission from CF patients coughing making them cough onto a dish held by the patients themselves then onto a plate held at a distance of about a meter In the second study six PA-colonized patients coughed in the direction of a soap bubble holder held at a distance of 10 cm 20 cm 30 cm 40 cm and 50 cm from the mouth
The results obtained in these two studies have shown the possibility of transmitting PA through coughing at a distance of at least one meter and the possibility of emitting PA at distances greater than 40 cm However these studies do not provide proof that one meter is an effective indicator of the distance necessary for preventing PA emitted by one patient from reaching another
It appears that no study has ever investigated if PA can be expelled from a carriers respiratory tract by coughing at a distance greater than the recommended one meter safety distance between CF patients and no study has been done on the maximum distance PA emitted during a normal conversation can reach
In any case aside from the distance PA can actually reach there are no studies on the effectiveness of a 1-meter distance between CF patients as a measure for preventing PA cross-infections
Since there are very few data available on how far PA emitted from the respiratory tract of a colonized CF patient through coughing can reach and no data relative to simple conversation the recommendation of a one-meter distance does not seem to be backed up by sufficient evidence In other words one meter may not be a great enough distance for preventing the potential risk of transmission therefore the recommendation to maintain a minimum distance of one meter may be inadequate
Our study thus intends to contribute to filling the knowledge gap to this regard and to clarifying the validity of the minimum distance of one meter as a prevention measure in the transmission of PA from one CF patient to another
The objectives in this study are
To evaluate what distance can be reached by PA expelled through the emission of droplets from the respiratory tract of a CF patient during a simple conversation and coughing
To verify if the 1-meter distance from patients colonized by PA is actually an effective prevention measure in regard to PA infection as reported in the International Guidelines
Experimental study not checked with convenience sample This study will evaluate the distance reached by Pseudomonas aeruginosa after a normal conversation and after coughing by CF patients
With this aim we will evaluate the presence of PA on surfaces at 4 different distances from the patient by culturing 8 swabs taken from the surfaces themselves 4 of which after normal conversation and 4 others after coughing
Data collection At the time of inclusion in the study the following data will be collected Patient name and surname age in months Rx score FEV1 BMI Micro-organisms present in the previous and current expectorate culture PCR
After collecting the specimens and preparing the culture plates PA growth in the mediums corresponding to the various collection distances will be observed
The results of the laboratory analysis will be reported in the patients file thus
Presence of Pseudomonas Aeruginosa
after conversation 0 - 05 m 05 - 100 m 100 - 15 m 150 - 200 m
after coughing 0 - 05 m 05 - 100 m 100 - 15 m 150 - 200 m
Safety measures Personnel will wear single-use gloves and coats
Data management and statistical analysis The data will be entered into Microsoft Access 2000 database For each of the four distances and for each of the two modes coughing and conversation the percentage of PA presence will be determined and the confidence intervals will be defined to 95 of the percentages
Moreover we will look for associations between the presenceabsence of PA at each distance and for each of the modes and the clinical variables in each patient
For qualitative variables statistical analysis will be made with Chi-square test For quantitative variables statistical analysis will be done with Students T-distribution
Expected Results
We expect to obtain estimates of the proportion of contaminated areas so as to estimate the CF patient risk of being reached by secretions expelled from the respiratory tract of other CF patients at different distances
Clinical protocols
Recruitment
Upon a patient receiving a check-up at the CF Centre the researcher will decide on the basis of demographics and microbiology if the patient can be included in the study group
If the patient has reached the age of 14 and the last microbiological culture of his expectorate is positive for PA the patient will be asked and his parents if under age to participate in the study and will be given background information After all his questions are answered if the patient decides to participate his written consent will be taken co-signed by his parents if under age Subsequently the patients entry data will be taken by filling out a patient questionnaire after which the specimens will be collected
The study does not call for the assignment of a therapeutic strategy the clinical and laboratory data relative to the patients participating in the study will be obtained during routine follow-up without modifying current clinical practice
Specimen collection methods To collect the specimens a special ruled table 05 X 210 will be set up and covered with a single-use waterproof surgical cloth after the patient has been enlisted in the study
The patient will then be asked to place himself in front of the table at the 0 m point
The table will be regulated according to the patients height at the level of his navel
Then the patient will be asked to read a text placed in front of him out loud in order to recreate a normal conversation
We will then proceed to take the specimens with 4 sterile swabs each one of which will be used for collecting specimens on the table surface subdivided into the following distances 0 - 05 m 05 - 100 m 100 - 15 m 150 - 200 m
Specimen collection with a sterile swab from the surface of the sterile cloth will be done by rubbing entirely each of the four surfaces into which the sterile cloth is subdivided entirely using a boustrophedonic movement
After the first set is collected the single-use cloth will be substituted in order to restore sterile conditions
Next the patient will be asked to perform two FET sequences which consist in giving one or two forced expirations with the glottis open starting with medium-low lung volume followed by a rest period in which diaphragm breathing is maintained At this point the collection of the next 4 specimens will be taken in the method described above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None