Ventilator-associated PneumoniaNCT02585180
Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia
A study testing Endotracheal tubes not allowing SSD and Endotracheal tubes allowing SSD in people with Ventilator-associated Pneumonia, run by Centre Hospitalier Departemental Vendee at 15 sites in 2 countries.
Trial summary
Many studies provide evidence for the benefit of lower respiratory tract surveillance, mostly by culture of endotracheal secretions, to predict bacterial pathogens (especially multi-drugs resistant pathogens) involved in VAP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-associated Pneumonia
- What is being tested?
- Endotracheal tubes not allowing SSD and Endotracheal tubes allowing SSD
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 4 Nov 2015to 29 Nov 2017
- Phase
- Interventional
- 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
Who may be able to join
- Age over 18 years
- Invasive mechanical ventilation delivered via an endotracheal tube and expected to be required more than 24 hours
- Intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage will be available during the SSD period of the trial
- Information delivered
Who cannot join
- Previous inclusion in the study
- Patients moribund at the Intensive Care Unit admission
- Pregnant, parturient or breast-feeding woman
- Patient hospitalized without consent and/or deprived of liberty by court's decision
- Patient under guardianship or curators
- Lack of social insurance
- Concomitant inclusion in a trial on VAP prevention
- Patient with no comprehension of the French language
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
France14 sites
CH Annecy Genevois
Annecy, 74374
Centre Hospitalier Victor Dupouy
Argenteuil, 95100
Centre Hospitalier Intercommunal des Portes de l'Oise
Beaumont-sur-Oise, 95260
Chd Vendee
La Roche-sur-Yon, 85170
CH Docteur Schaffner
Lens, 62307
CH de Montauban
Montauban, 82013
Centre Hospitalier Régional d'Orléans
Orléans, 45067
CHU Pointe à Pitre les Abymes
Pointe à Pitre, 97159
CHI Poissy Saint Germain
Poissy, 78600
Centre Hospitalier René Dubos
Pontoise, 95303
CHU La Réunion, site de Saint Denis de la Réunion
Saint-Denis (Réunion), 97405
CH de Saint Nazaire
Saint-Nazaire, 44606
CHU de Strasbourg Nouvel Hôpital Civil
Strasbourg, 67000
CHU Tours, site Bretonneau
Tours, 37044
About this study
Official title: Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia (VAP): an Ancillary Study of the DEMETER Trial (NCT02515617)
Many studies provide evidence for the benefit of lower respiratory tract surveillance, mostly by culture of endotracheal secretions, to predict bacterial pathogens (especially multi-drugs resistant pathogens) involved in VAP. The DEMETER study (NCT02515617) assessing the medico-economical impact of the subglottic secretions drainage (SSD) provides the opportunity to evaluate the accuracy of the subglottic secretions culture surveillance to predict pathogens involved in VAP (in comparison with the concomitant endotracheal secretions surveillance). These subglottic and tracheal secretions culture surveillance will be masked to the investigators of the DEMETER Study.
This ancillary study will be performed in 14 centers participating to the DEMETER study
- Conditions
- Ventilator-associated Pneumonia
- Being tested
- Endotracheal tubes not allowing SSD, Endotracheal tubes allowing SSD
- Keywords
- Ventilator-associated pneumonia, Surveillance, Subglottic-secretions, Critically ill patients, Prevention
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal tubes not allowing SSDDevice
In each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure
Endotracheal tubes allowing SSDDevice
In each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure.
In addition, SSD will be realized using a 10 ml syringe at in attending frequency of 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Period with endotracheal tubes not allowing SSD | Active comparator | During this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Drainage Receives: Device: Endotracheal tubes not allowing SSD |
| Period with endotracheal tubes allowing SSD | Experimental | During this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage Receives: Device: Endotracheal tubes allowing SSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the subglottic secretions culture surveillance.
For each episode of VAP, bacteria involved will be compared with bacteria isolated, previously, into the subglottic secretions. This comparison will be performed by the microbiologist of each center. A bacteria isolated into the subglottic secretions will be considered as the same than the one involved in VAP if these 2 same micro-organisms have the same antibiotics susceptibility. Moreover, for the comparison, the third last subglottic secretions samples, if available, obtained before the VAP occurrence, will be taking account.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Secondary outcomes (4)
Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the tracheal secretions culture surveillance.
For each episode of VAP, bacteria involved will be compared with bacteria isolated, previously, into the tracheal secretions. This comparison will be performed by the microbiologist of each center. A bacteria isolated into the tracheal secretions will be considered as the same than the one involved in VAP if these 2 same microorganisms have the same antibiotics susceptibility. Moreover, for the comparison, the third last tracheal secretions samples, if available, obtained before the VAP occurrence will be taking account.
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Adequate probabilistic antibiotherapy initiated during the study by the investigators in case of adjudicated VAP
Proportion of VAP for whom the probabilistic antibiotherapy used during the trial appeared to be empirically active
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Adequate theoretical probabilistic antibiotherapy with the knowledge of the subglottic culture surveillance
Proportion of adjudicated VAP for whom a theoretical probabilistic antibiotherapy would be empirically active with the knowledge of the results of the subglottic secretions samples obtained more than 3 days before the occurrence of VAP. The theoretical antibiotherapy will be determined by an independent committee unaware of the type of samples evaluated (subglottic or tracheal secretions).
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Adequate theoretical probabilistic antibiotherapy with the knowledge of the tracheal culture surveillance
Proportion of adjudicated VAP for whom a theoretical probabilistic antibiotherapy would be empirically active with the knowledge of the results of the tracheal secretions samples obtained more than 3 days before the occurrence of VAP. The theoretical antibiotherapy will be determined by an independent committee unaware of the type of samples evaluated (subglottic or tracheal secretions).
Measured: Until weaning of mechanical ventilation, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study start4 Nov 2015
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator-associated PneumoniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, University Hospital, Tours
- Responsible party
- Sponsor
- Investigators
- Jean-Claude LACHERADE, MD, Principal investigator, CHD VENDEE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585180
- Sponsor's protocol ID
- CHD 052-15
- Status last verified
- Mar 2021
- First submitted
- 20 Oct 2015
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brusselaers N, Labeau S, Vogelaers D, Blot S. Value of lower respiratory tract surveillance cultures to predict bacterial pathogens in ventilator-associated pneumonia: systematic review and diagnostic test accuracy meta-analysis. Intensive Care Med. 2013 Mar;39(3):365-75. doi: 10.1007/s00134-012-2759-x. Epub 2012 Nov 28.
PubMed 23188467
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia (VAP): an Ancillary Study of the DEMETER Trial (NCT02515617)
- ClinicalTrials.gov ID
- NCT02585180
- Acronym / sponsor ID
- CHD 052-15
- Conditions
- Ventilator-associated Pneumonia
- Keywords
- Ventilator-associated pneumonia, Surveillance, Subglottic-secretions, Critically ill patients, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Collaborators
- Ministry of Health, France, University Hospital, Tours
- Study start
- 4 Nov 2015 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 23 Oct 2015 (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.
Many studies provide evidence for the benefit of lower respiratory tract surveillance, mostly by culture of endotracheal secretions, to predict bacterial pathogens (especially multi-drugs resistant pathogens) involved in VAP. The DEMETER study (NCT02515617) assessing the medico-economical impact of the subglottic secretions drainage (SSD) provides the opportunity to evaluate the accuracy of the subglottic secretions culture surveillance to predict pathogens involved in VAP (in comparison with the concomitant endotracheal secretions surveillance). These subglottic and tracheal secretions culture surveillance will be masked to the investigators of the DEMETER Study.
This ancillary study will be performed in 14 centers participating to the DEMETER study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period with endotracheal tubes not allowing SSD | Active comparator | Device: Endotracheal tubes not allowing SSDDuring this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Drainage |
| Period with endotracheal tubes allowing SSD | Experimental | Device: Endotracheal tubes allowing SSDDuring this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years
- Invasive mechanical ventilation delivered via an endotracheal tube and expected to be required more than 24 hours
- Intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage will be available during the SSD period of the trial
- Information delivered
Key exclusion criteria (8 listed)
- Previous inclusion in the study
- Patients moribund at the Intensive Care Unit admission
- Pregnant, parturient or breast-feeding woman
- Patient hospitalized without consent and/or deprived of liberty by court's decision
- Patient under guardianship or curators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endotracheal tubes not allowing SSDIn each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure | Device | Period with endotracheal tubes not allowing SSD |
| Endotracheal tubes allowing SSDIn each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure. In addition, SSD will be realized using a 10 ml syringe at in attending frequency of 2 hours. | Device | Period with endotracheal tubes allowing SSD |
Primary outcome
Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the subglottic secretions culture surveillance.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
For each episode of VAP, bacteria involved will be compared with bacteria isolated, previously, into the subglottic secretions. This comparison will be performed by the microbiologist of each center. A bacteria isolated into the subglottic secretions will be considered as the same than the one involved in VAP if these 2 same micro-organisms have the same antibiotics susceptibility. Moreover, for the comparison, the third last subglottic secretions samples, if available, obtained before the VAP occurrence, will be taking account.
4 secondary outcomes
Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the tracheal secretions culture surveillance.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Adequate probabilistic antibiotherapy initiated during the study by the investigators in case of adjudicated VAP
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Adequate theoretical probabilistic antibiotherapy with the knowledge of the subglottic culture surveillance
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Adequate theoretical probabilistic antibiotherapy with the knowledge of the tracheal culture surveillance
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
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 23 Mar 2021.
- Background: PubMed 23188467Brusselaers N, Labeau S, Vogelaers D, Blot S. Value of lower respiratory tract surveillance cultures to predict bacterial pathogens in ventilator-associated pneumonia: systematic review and diagnostic test accuracy meta-analysis. Intensive Care Med. 2013 Mar;39(3):365-75. doi: 10.1007/s00134-012-2759-x. Epub 2012 Nov 28.
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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.
Jean-Claude LACHERADE, MD principal investigator
CHD VENDEE
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal tubes not allowing SSD and Endotracheal tubes allowing SSD in people with Ventilator-associated Pneumonia, run by Centre Hospitalier Departemental Vendee at 15 sites in 2 countries.
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 4 inclusion and 8 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 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Belgium. 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?
Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the subglottic secretions culture surveillance. (time frame: Until weaning of mechanical ventilation, an expected average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02585180, which also lists 1 linked publication.
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 23 Mar 2021.