Early Ventilation Acquired Pneumonia in Brain Injured PatientsPhase 3PROPHY-VAPNCT02265406
PROPHY-VAP: Prevention of Early Ventilation Acquired Pneumonia (VAP) in Brain Injured Patients by a Single Dose of Ceftriaxone
A Phase 3 study testing Anti-Infective Agents in people with Early Ventilation Acquired Pneumonia in Brain Injured Patients, run by Poitiers University Hospital at 8 sites in France.
Trial summary
Ventilation-associated pneumonia (VAP) is the main site of healthcare-associated infections in the brain injured patients, with an incidence rate of 22% to 58%. VAP increases morbi-mortality, length of stay in intensive care and overall management costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Ventilation Acquired Pneumonia in Brain Injured Patients
- What is being tested?
- Anti-Infective Agents
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 354 participants
- Where
- 8 sitesFrance
- Study dates
- Oct 2015to 25 Jul 2020
- Phase
- Phase 3
- 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
- Brain injured patients with a Glasgow scale score ≤ 12 who require ventilation more than 48 hours
Who cannot join
- Patient with a high risk of death within the 48 first hours after admission,
- Patient intubated for more than12 hours
- Intubation after the 48th hours after admission
- Coverage to cardiopulmonary arrest
- Coma due to a tumor, an infectious disease or a cardiac arrest
- Previous hospitalisation within the last month before admission for coma
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- béta-lactamines allergy
- Patient who receive already antibiotics at the admission for a previous infection
- Prophylactic antibiotic due to be done within 24 hours following the randomisation
- Patient Intubated through a tracheal tube with subglottic secretion aspiration
- Patient with a tracheotomy
- Patient or family refuse to be involved in the study
- Use of Ceftriaxone within 2 days before enrolment
- Participation in another research protocol focusing on an anti-infective treatment or on a measure decreasing the risk of infection
- Patients not affiliated to a social security scheme, Pregnant woman or breast-feeding mother, Patients deprived of their liberty by judicial or administrative decision
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
University Hospital of Angers
Angers, 49933
CHU
Bordeaux
CHRU
Montpellier
University Hospital of Nantes
Nantes, 44093
University Hospital of Poitiers
Poitiers, 86021
University Hospital of Rennes
Rennes, 35033
Thomas GEERAERTS
Toulouse, 31059
Djilali ELAROUSSI
Tours, 37000
About this study
Ventilation-associated pneumonia (VAP) is the main site of healthcare-associated infections in the brain injured patients, with an incidence rate of 22% to 58%. VAP increases morbi-mortality, length of stay in intensive care and overall management costs. The prevention of ICU nosocomial infections depends on several measures : orotracheal intubation route, maintaining tube cuff pressure between 25 and 30 cm of water (H2O), maintaining a semi-seated position >= 30°, nasal and oropharyngeal care at regular intervals, striving to avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for early weaning from ventilation. Two randomized study show that administration of antibiotic therapy after intubation reduces the risk of early VAP incidence. However, in clinical practice, its administration solely purposes of limiting VAP occurence is not presently recommended. Indeed, to date no placebo blind controlled study was been realized and the fear of development of bacterial resistance remains stronger than the efficiency of this prevention measure. This aim of the present study is to show by a placebo randomized study that 2g of Ceftriaxone within 8 hours post-intubation after a brain injury decrease the risk of occurence an early VAP.
Ancillary study An ancillary study is performed in 2 centres which routinely practice rectal swabs at admission and discharge of ICU, to survey intestinal flora (CHU of Angers and CHU of Rennes). The goal of this study is to compare the incidence of acquired cephalosporin resistant gram negative bacteria at the discharge of ICU between the 2 groups of patients, receiving or not ceftriaxone.
- Being tested
- Anti-Infective Agents, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Infective AgentsDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ceftriaxone | Experimental | Not described Receives: Drug: Anti-Infective Agents |
| Sodium Chloride | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of early VAP, proportion of patients who develop a VAP within the 7 first day after mechanical ventilation (the 7th day included), confirm with microbiological culture, within all included patients.
Measured: 30 months
Secondary outcomes (14)
- Incidence of late VAP (> 7 jours)
Measured: 30 months
- Global incidence of VAP during intensive care period (limited to day 60)
Measured: 30 months
- Type of bacteria and their sensitivity for early or late VAP,
Measured: 30 months
- Time between inclusion and occurence of the first VAP (limited to day 28),
Measured: 30 months
- Length of the first period of mechanical ventilation during the intensive care period,
Measured: 30 months
- Time between inclusion and the first spontaneous ventilation test (limited to day 28),
Measured: 30 months
- Length of antibiotherapy during intensive care period,
Measured: 30 months
- Length of intensive care, limited to 60 days,
Measured: 30 months
- Length of stay in intensive care unit, limited to 60 days,
Measured: 30 months
- Length of stay at the hospital, limited to 60 days,
Measured: 30 months
- Neurological prognosis at the discharge of the intensive care unit,
Measured: 30 months
- Mortality at day 28 and 60.
Measured: 30 months
- Incidence of ventilated associated event (limited to day 60)
Measured: 30 months
- Comparison of the global incidence of VAP according to the diagnosis defined by "American Thoracic Society" or by "Centers for Disease Control"
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startOct 2015
- Primary completion25 Jul 2020
- Study completion25 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early Ventilation Acquired Pneumonia in Brain Injured PatientsStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265406
- Sponsor's protocol ID
- PROPHY-VAP
- Acronym
- PROPHY-VAP
- Status last verified
- Feb 2021
- First submitted
- 9 Oct 2014
- Last updated
- 3 Feb 2021
- Results posted
- No
Publications
Dahyot-Fizelier C, Lasocki S, Kerforne T, Perrigault PF, Geeraerts T, Asehnoune K, Cinotti R, Launey Y, Cottenceau V, Laffon M, Gaillard T, Boisson M, Aleyrat C, Frasca D, Mimoz O; PROPHY-VAP Study Group and the ATLANREA Study Group. Ceftriaxone to prevent early ventilator-associated pneumonia in patients with acute brain injury: a multicentre, randomised, double-blind, placebo-controlled, assessor-masked superiority trial. Lancet Respir Med. 2024 May;12(5):375-385. doi: 10.1016/S2213-2600(23)00471-X. Epub 2024 Jan 20.
PubMed 38262428Dahyot-Fizelier C, Frasca D, Lasocki S, Asehnoune K, Balayn D, Guerin AL, Perrigault PF, Geeraerts T, Seguin P, Rozec B, Elaroussi D, Cottenceau V, Guyonnaud C, Mimoz O; PROPHY-VAP Study group, ATLANREA group. Prevention of early ventilation-acquired pneumonia (VAP) in comatose brain-injured patients by a single dose of ceftriaxone: PROPHY-VAP study protocol, a multicentre, randomised, double-blind, placebo-controlled trial. BMJ Open. 2018 Oct 18;8(10):e021488. doi: 10.1136/bmjopen-2018-021488.
PubMed 30341115
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROPHY-VAP: Prevention of Early Ventilation Acquired Pneumonia (VAP) in Brain Injured Patients by a Single Dose of Ceftriaxone
- ClinicalTrials.gov ID
- NCT02265406
- Acronym / sponsor ID
- PROPHY-VAP / PROPHY-VAP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 25 Jul 2020 (actual)
- Study completion
- 25 Jul 2020 (actual)
- First posted
- 15 Oct 2014 (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.
Ventilation-associated pneumonia (VAP) is the main site of healthcare-associated infections in the brain injured patients, with an incidence rate of 22% to 58%. VAP increases morbi-mortality, length of stay in intensive care and overall management costs. The prevention of ICU nosocomial infections depends on several measures : orotracheal intubation route, maintaining tube cuff pressure between 25 and 30 cm of water (H2O), maintaining a semi-seated position >= 30°, nasal and oropharyngeal care at regular intervals, striving to avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for early weaning from ventilation. Two randomized study show that administration of antibiotic therapy after intubation reduces the risk of early VAP incidence. However, in clinical practice, its administration solely purposes of limiting VAP occurence is not presently recommended. Indeed, to date no placebo blind controlled study was been realized and the fear of development of bacterial resistance remains stronger than the efficiency of this prevention measure. This aim of the present study is to show by a placebo randomized study that 2g of Ceftriaxone within 8 hours post-intubation after a brain injury decrease the risk of occurence an early VAP.
Ancillary study An ancillary study is performed in 2 centres which routinely practice rectal swabs at admission and discharge of ICU, to survey intestinal flora (CHU of Angers and CHU of Rennes). The goal of this study is to compare the incidence of acquired cephalosporin resistant gram negative bacteria at the discharge of ICU between the 2 groups of patients, receiving or not ceftriaxone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftriaxone | Experimental | Drug: Anti-Infective Agents |
| Sodium Chloride | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Brain injured patients with a Glasgow scale score ≤ 12 who require ventilation more than 48 hours
Key exclusion criteria (15 listed)
- Patient with a high risk of death within the 48 first hours after admission,
- Patient intubated for more than12 hours
- Intubation after the 48th hours after admission
- Coverage to cardiopulmonary arrest
- Coma due to a tumor, an infectious disease or a cardiac arrest
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 |
|---|---|---|
| Anti-Infective Agents | Drug | Ceftriaxone |
| Placebo | Drug | Sodium Chloride |
Primary outcome
Incidence of early VAP, proportion of patients who develop a VAP within the 7 first day after mechanical ventilation (the 7th day included), confirm with microbiological culture, within all included patients.
Time frame: 30 months
14 secondary outcomes
- Incidence of late VAP (> 7 jours)
Time frame: 30 months
- Global incidence of VAP during intensive care period (limited to day 60)
Time frame: 30 months
- Type of bacteria and their sensitivity for early or late VAP,
Time frame: 30 months
- Time between inclusion and occurence of the first VAP (limited to day 28),
Time frame: 30 months
- Length of the first period of mechanical ventilation during the intensive care period,
Time frame: 30 months
- Time between inclusion and the first spontaneous ventilation test (limited to day 28),
Time frame: 30 months
- Length of antibiotherapy during intensive care period,
Time frame: 30 months
- Length of intensive care, limited to 60 days,
Time frame: 30 months
- Length of stay in intensive care unit, limited to 60 days,
Time frame: 30 months
- Length of stay at the hospital, limited to 60 days,
Time frame: 30 months
- Neurological prognosis at the discharge of the intensive care unit,
Time frame: 30 months
- Mortality at day 28 and 60.
Time frame: 30 months
- Incidence of ventilated associated event (limited to day 60)
Time frame: 30 months
- Comparison of the global incidence of VAP according to the diagnosis defined by "American Thoracic Society" or by "Centers for Disease Control"
Time frame: 30 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 Feb 2021.
- Derived from this study: PubMed 38262428Dahyot-Fizelier C, Lasocki S, Kerforne T, Perrigault PF, Geeraerts T, Asehnoune K, Cinotti R, Launey Y, Cottenceau V, Laffon M, Gaillard T, Boisson M, Aleyrat C, Frasca D, Mimoz O; PROPHY-VAP Study Group and the ATLANREA Study Group. Ceftriaxone to prevent early ventilator-associated pneumonia in patients with acute brain injury: a multicentre, randomised, double-blind, placebo-controlled, assessor-masked superiority trial. Lancet Respir Med. 2024 May;12(5):375-385. doi: 10.1016/S2213-2600(23)00471-X. Epub 2024 Jan 20.
- Derived from this study: PubMed 30341115Dahyot-Fizelier C, Frasca D, Lasocki S, Asehnoune K, Balayn D, Guerin AL, Perrigault PF, Geeraerts T, Seguin P, Rozec B, Elaroussi D, Cottenceau V, Guyonnaud C, Mimoz O; PROPHY-VAP Study group, ATLANREA group. Prevention of early ventilation-acquired pneumonia (VAP) in comatose brain-injured patients by a single dose of ceftriaxone: PROPHY-VAP study protocol, a multicentre, randomised, double-blind, placebo-controlled trial. BMJ Open. 2018 Oct 18;8(10):e021488. doi: 10.1136/bmjopen-2018-021488.
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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anti-Infective Agents in people with Early Ventilation Acquired Pneumonia in Brain Injured Patients, run by Poitiers University Hospital at 8 sites in France.
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 1 inclusion and 15 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 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of early VAP, proportion of patients who develop a VAP within the 7 first day after mechanical ventilation (the 7th day included), confirm with microbiological culture, within all included patients. (time frame: 30 months). 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 NCT02265406, which also lists 2 linked publications.
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 Feb 2021.