Pneumonia, Ventilator-AssociatedNCT01875692
Can we Better Understand the Development of VAP and Eventually Predict and Prevent it?
An observational study of Pneumonia, Ventilator-Associated, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Pathogens of ventilator-associated pneumonia (VAP) come from colonizers of the trachea. The hypothesis of the investigators is that during the first days of intubation, independently of the use of antibiotics, there is a change in the oro-pharyngeal flora leading to the selection of one pathogen in the trachea, that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- How many people
- 286 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU adult patients intubated in the last 24h for a condition that will probably require more than 3 days of mechanical ventilation.
Who may be able to join
- Patient hospitalised in the adult ICU of HUG (>18 years old)
- Intubated for < 24 hours
- Expected duration of intubation > 4 days (e.g. neurologic disease)
Who cannot join
- Patients for whom regular tracheal aspirations cannot not be performed (because of unstable intracranial pressure, for example).
- New antibiotic therapy in the week preceding the intubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Culture Versus Genomics: Study of Oropharyngeal and Tracheal Flora in Intubated Patients. Can we Better Understand the Development of Ventilator-Acquired Pneumonia (VAP) and Predict Its Causing Pathogen(s)?
Pathogens of ventilator-associated pneumonia (VAP) come from colonizers of the trachea. The hypothesis of the investigators is that during the first days of intubation, independently of the use of antibiotics, there is a change in the oro-pharyngeal flora leading to the selection of one pathogen in the trachea, that will finally be the cause of VAP.
The investigators designed a prospective study including 300 patients intubated for more than 3 days, with daily analysis of oro-pharyngeal juice and tracheal aspirate by culture and metagenomics, in order to determine if this microbiological surveillance permits:
- To predict a high risk to develop a VAP in the next 48h and even to predict its agent
- To better understand the development of VAP by studying the evolution of the "respiratory flora" in the context of intubation
Read the detailed description
BACKGROUND OF THE STUDY:
The ventilator-associated pneumonia (VAP) is responsible for almost half of infections acquired in intensive care, affecting up to 28% of mechanically ventilated patients with a mortality rate ranging from 25 to 50%. The majority of these VAP originate in the sub-glottic juice that accumulates just above the endotracheal tube cuff. Many preventive measures exist and are applied in this institution, including oropharyngeal aspiration every 4 hours and tracheal aspirates every 8 hours. Currently, these aspirates are simply discarded. However, a French study evaluating the colonization and infection of the respiratory tract of patients with acute respiratory distress syndrome (ARDS) has highlighted that the causative agent of VAP is selected in more than 2/3 of the cases in tracheal aspirates several days before the VAP. This suggest that "microbiological surveillance" of daily aspirates may permit the identification of a selected respiratory pathogen later responsible of VAP.
Parallel to this, the rapid development of genomics has highlighted the role of flora (microbiota) and its link with disease (eg, colitis and intestinal microbiota inflammatory). This area is also emerging in the field of respiratory tract infections, for example in patients with chronic obstructive pulmonary disease (COPD) or asthma. There is no description yet of metagenomics changes in respiratory flora of patients intubated with or without VAP, neither evaluation of the benefits of such an approach in relation to classical microbiology. The investigators believe that studying the respiratory flora of ventilated patients could provide clues to better understand the development of VAP.
METHODOLOGY (plan, inclusion and objectives):
Prospective study of 300 intubated patients recruited during a period of 2 years, in whom tracheal aspirates and oropharyngeal juice collected daily will be analyzed by culture and metagenomics, instead of being simply discarded. The results of these analyzes will be used only for research purposes (culture and metagenomics in parallel).
The main objective is to determine whether daily monitoring of oropharyngeal juice and tracheal aspirates by culture identifies the selection of a pathogen among the colonizing flora, which would be predictive of the onset of VAP in 48-72 hours.
The secondary objectives are to obtain new knowledge on the kinetics of colonization and respiratory infections in intubated patients, compare the advantages and disadvantages of a metagenomic approach compared to culture in this context, and study the influence of antibiotherapy in this context.
- Conditions
- Pneumonia, Ventilator-Associated
- Keywords
- Metagenomic, Ventilator-Associated Pneumonia (VAP)
- Medical subject headings
- Pneumonia, Ventilator-Associated
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of cases where tracheal (same for oropharyngeal) aspirate clearly showing a selection of the same pathogen retrieved later in the bronchoalveolar lavage (BAL), when VAP happens.
This will provide the sensitivity of tracheal culture to identify correctly the agent of VAP before VAP happens.
Measured: After 18 months
Percentage of case where the pathogen selected in tracheal (same for oropharyngeal) aspirate do not correspond to the agent of VAP as identified by BAL.
Helps to determine the "specificity" of tracheal aspirates to predict the agent of VAP.
Measured: After 18 months
Percentage of cases where despite the selection of only one pathogen in tracheal aspirate (same for oropharyngeal) aspirate, the patient did never suffer from VAP
Helps determining the positive and negative predictive values of tracheal aspirates to predict VAP.
Measured: After 18 months
Presence of Ventilator-Associated-Pneumonia (VAP)
Measured: After 18 month
Secondary outcomes (3)
Percentage of VAP in the study population
Measured: After 18 months
Type of bacteria retrieved on intubation day compared to type of bacteria retrieved after 1 week of intubation
The investigators expect to find normal oropharyngeal flora on intubation day but Gram negative pathogens after one week, despite the absence of antibiotherapy.
This will be compared with and without antibiotherapy.
Measured: After 18 months
Evolution of metagenomics of oropharyngeal - tracheal aspirates in cases (VAP) and control (no VAP)
For patients suffering from VAP, metagenomics will also be assessed in the BAL. This will give the investigators some clues on the "respiratory flora" equilibrium and its evolution in cases and control
Measured: After 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Jacques SCHRENZEL, University Hospital, Geneva
- Investigators
- Jacques Schrenzel, Prof., Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875692
- Sponsor's protocol ID
- 12-051
- Status last verified
- Dec 2014
- First submitted
- 15 Mar 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culture Versus Genomics: Study of Oropharyngeal and Tracheal Flora in Intubated Patients. Can we Better Understand the Development of Ventilator-Acquired Pneumonia (VAP) and Predict Its Causing Pathogen(s)?
- ClinicalTrials.gov ID
- NCT01875692
- Acronym / sponsor ID
- 12-051
- Conditions
- Pneumonia, Ventilator-Associated
- Keywords
- Metagenomic, Ventilator-Associated Pneumonia (VAP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pathogens of ventilator-associated pneumonia (VAP) come from colonizers of the trachea. The hypothesis of the investigators is that during the first days of intubation, independently of the use of antibiotics, there is a change in the oro-pharyngeal flora leading to the selection of one pathogen in the trachea, that will finally be the cause of VAP.
The investigators designed a prospective study including 300 patients intubated for more than 3 days, with daily analysis of oro-pharyngeal juice and tracheal aspirate by culture and metagenomics, in order to determine if this microbiological surveillance permits:
- To predict a high risk to develop a VAP in the next 48h and even to predict its agent
- To better understand the development of VAP by studying the evolution of the "respiratory flora" in the context of intubation
Detailed description
BACKGROUND OF THE STUDY:
The ventilator-associated pneumonia (VAP) is responsible for almost half of infections acquired in intensive care, affecting up to 28% of mechanically ventilated patients with a mortality rate ranging from 25 to 50%. The majority of these VAP originate in the sub-glottic juice that accumulates just above the endotracheal tube cuff. Many preventive measures exist and are applied in this institution, including oropharyngeal aspiration every 4 hours and tracheal aspirates every 8 hours. Currently, these aspirates are simply discarded. However, a French study evaluating the colonization and infection of the respiratory tract of patients with acute respiratory distress syndrome (ARDS) has highlighted that the causative agent of VAP is selected in more than 2/3 of the cases in tracheal aspirates several days before the VAP. This suggest that "microbiological surveillance" of daily aspirates may permit the identification of a selected respiratory pathogen later responsible of VAP.
Parallel to this, the rapid development of genomics has highlighted the role of flora (microbiota) and its link with disease (eg, colitis and intestinal microbiota inflammatory). This area is also emerging in the field of respiratory tract infections, for example in patients with chronic obstructive pulmonary disease (COPD) or asthma. There is no description yet of metagenomics changes in respiratory flora of patients intubated with or without VAP, neither evaluation of the benefits of such an approach in relation to classical microbiology. The investigators believe that studying the respiratory flora of ventilated patients could provide clues to better understand the development of VAP.
METHODOLOGY (plan, inclusion and objectives):
Prospective study of 300 intubated patients recruited during a period of 2 years, in whom tracheal aspirates and oropharyngeal juice collected daily will be analyzed by culture and metagenomics, instead of being simply discarded. The results of these analyzes will be used only for research purposes (culture and metagenomics in parallel).
The main objective is to determine whether daily monitoring of oropharyngeal juice and tracheal aspirates by culture identifies the selection of a pathogen among the colonizing flora, which would be predictive of the onset of VAP in 48-72 hours.
The secondary objectives are to obtain new knowledge on the kinetics of colonization and respiratory infections in intubated patients, compare the advantages and disadvantages of a metagenomic approach compared to culture in this context, and study the influence of antibiotherapy in this context.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU adult patients intubated in the last 24h for a condition that will probably require more than 3 days of mechanical ventilation.
Key inclusion criteria (3 listed)
- Patient hospitalised in the adult ICU of HUG (>18 years old)
- Intubated for < 24 hours
- Expected duration of intubation > 4 days (e.g. neurologic disease)
Key exclusion criteria (2 listed)
- Patients for whom regular tracheal aspirations cannot not be performed (because of unstable intracranial pressure, for example).
- New antibiotic therapy in the week preceding the intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of cases where tracheal (same for oropharyngeal) aspirate clearly showing a selection of the same pathogen retrieved later in the bronchoalveolar lavage (BAL), when VAP happens.
Time frame: After 18 months
This will provide the sensitivity of tracheal culture to identify correctly the agent of VAP before VAP happens.
Percentage of case where the pathogen selected in tracheal (same for oropharyngeal) aspirate do not correspond to the agent of VAP as identified by BAL.
Time frame: After 18 months
Helps to determine the "specificity" of tracheal aspirates to predict the agent of VAP.
Percentage of cases where despite the selection of only one pathogen in tracheal aspirate (same for oropharyngeal) aspirate, the patient did never suffer from VAP
Time frame: After 18 months
Helps determining the positive and negative predictive values of tracheal aspirates to predict VAP.
Presence of Ventilator-Associated-Pneumonia (VAP)
Time frame: After 18 month
3 secondary outcomes
Percentage of VAP in the study population
Time frame: After 18 months
Type of bacteria retrieved on intubation day compared to type of bacteria retrieved after 1 week of intubation
Time frame: After 18 months
Evolution of metagenomics of oropharyngeal - tracheal aspirates in cases (VAP) and control (no VAP)
Time frame: After 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
Related trials for Pneumonia, Ventilator-Associated
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Schrenzel, Prof. principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Ventilator-Associated, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of cases where tracheal (same for oropharyngeal) aspirate clearly showing a selection of the same pathogen retrieved later in the bronchoalveolar lavage (BAL), when VAP happens. (time frame: After 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.