Community-acquired PneumoniaPRONECAPNCT06966310

Awake Prone Positioning of Patients Suffering Community Acquired Pneumonia Requiring Nasal High Flow Therapy

A study testing Prone position in people with Community-acquired Pneumonia, run by University Hospital, Tours at 38 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Community acquired pneumonia, in particular when requiring oxygen therapy because of acute hypoxemic respiratory failure and meeting acute respiratory distress syndrome (ARDS) criteria frequently leads to tracheal intubation and poor outcome. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Community-acquired Pneumonia
What is being tested?: Prone position
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,078 participants
Where: 38 sitesFrance
Study dates: 30 Nov 2025to Oct 2034
Phase: Interventional
Are there results?: Not yet: the study is under way

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

Adult patients admitted to an intensive care unit or intermediate care unit
Suspicion of community acquired pneumonia (at least one of the 3 criteria): fever, cough, purulent expectoration
And abnormalities suggestive of pneumonia by chest X-ray or CT-scan
PaO2/FiO2 ratio <300 mmHg (or equivalent SpO2/FiO2 i.e. < 315 mmHg) under a minimum gas flow of 30 L/min.
Person affiliated to a French social security system or equivalent
Informed consent.

Who cannot join

Positive SARS-COV2 test within the last 30 days
Indication for immediate intubation
Patients for whom a "do not intubate" decision has been made
Chest trauma or other contraindication to prone position
Patients with formal indication for non-invasive ventilation: exacerbation of chronic obstructive pulmonary disease, acute cardiogenic pulmonary oedema.
Pregnant or breastfeeding woman

Show all 9Show fewer

Subjects who are under legal protection measure
More than 8h awake prone positioning prior to inclusion
More than 48h since intensive care unit or intermediate care unit admission.

Trial locations and contacts

38 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Stephan EHRMANN contact

2.47.47.38.55 ext. +33

stephanehrmann@gmail.com

City, postcode or hospital

Sites recruiting now only

38 sites in 1 country

France38 sites, 38 recruiting

Intensive care, University Hospital, Amiens
Amiens
Clément BRAULT
Clément BRAULT
Not yet recruiting
Intensive care, University Hospital, Angers
Angers
Pierre ASFAR
Pierre ASFAR
Not yet recruiting
Intensive care, University Hospital, Argenteuil
Argenteuil
Gaëtan PLANTEFEVE
Gaëtan PLANTEFEVE
Not yet recruiting
Intensive care, University Hospital, Belfort
Belfort
Julio BADIE
Julio BADIE
Not yet recruiting
Intensive care, University Hospital, Besancon
Besançon
Thibault VIEILLE
Thibault VIEILLE
Not yet recruiting
Intensive care, University Hospital, Bethune
Béthune
Ghada SBOUI
Ghada SBOUI
Not yet recruiting
Intensive care, University Hospital, Blois
Blois
Julien GROUILLE
Julien GROUILLE
Not yet recruiting
Intensive care, University Hospital, Bordeaux
Bordeaux
Alexandre BOYER
Alexandre BOYER
Not yet recruiting
Intensive care, University Hospital, Bourg en Bresse
Bourg-en-Bresse
Nicholas SEDILLOT
Nicholas SEDILLOT
Not yet recruiting
Intensive care, University Hospital, Bourges
Bourges
Anna BOURREAU
Anna BOURREAU
Recruiting
Intensive care, University Hospital, Brest
Brest
Gwénaël PRAT
Gwénaël PRAT
Not yet recruiting
Intensive care, University Hospital, Colombes
Colombes
Damien ROUX
Damien ROUX Damien
Not yet recruiting
Intensive care, University Hospital, Dieppe
Dieppe
Pierre-Louis DECLERCQ
Pierre-Louis DECLERCQ
Not yet recruiting
Intensive care, University Hospital, Dijon
Dijon
Jean-Pierre QUENOT
Jean-Pierre QUENOT
Recruiting
Intensive care, University Hospital, Dreux
Dreux
Florent BAVOZET
Florent BAVOZET
Not yet recruiting
Intensive care, University Hospital, Garches
Garche
Djillali ANNANE
Djillali ANNANE
Not yet recruiting
Intensive care, University Hospital, Grenoble
Grenoble
Guilhem WATTECAMPS
Guilhem WATTECAMPS
Not yet recruiting
Intensive care, University Hospital, La Roche sur Yon
La Roche-sur-Yon
Jean-Claude LACHERADE
Jean-Claude LACHERADE
Recruiting
Intensive care, University Hospital, Le Mans
Le Mans
Mickael LANDAIS
Mickael LANDAIS
Recruiting
Intensive care, University Hospital, Lens
Lens
Camille PROUTEAU
Camille PROUTEAU
Recruiting
Intensive care, University Hospital, Lille
Lille
Saadalla NSEIR
Saadalla NSEIR
Not yet recruiting
Intensive care, University Hospital, Lorient
Lorient
Guillaume GRILLET
Guillaume GRILLET
Not yet recruiting
Intensive care, University Hospital, Lyon
Lyon
Hodane YONIS
Hodane YONIS
Not yet recruiting
Intensive care, University Hospital, Lyon
Lyon
Laurent ARGAUD
Laurent ARGAUD
Not yet recruiting
Intensive care, University Hospital, Morlaix
Morlaix
Pierre-Yves EGRETEAU
Pierre-Yves EGRETEAU
Recruiting
Intensive care, University Hospital, Nantes
Nantes
Jean REIGNIER
Jean REIGNIER
Recruiting
Intensive care, University Hospital, Nice
Nice
Clément SACCHERI
Clément SACCHERI
Not yet recruiting
Intensive care, University Hospital, Nice
Nice
Robert ALEXANDRE
Robert ALEXANDRE
Not yet recruiting
Intensive care, University Hospital, Orléans
Orléans
François BARBIER
François BARBIER
Not yet recruiting
Intensive care, University Hospital, Cochin
Paris
Jean-Paul MIRA
Jean-Paul MIRA
Not yet recruiting
Intensive care, University Hospital, Tenon
Paris
Muriel FARTOUKH
Muriel FARTOUKH
Not yet recruiting
Intensive care, University Hospital, Poitiers
Poitiers
Arnaud THILLE
Arnaud THILLE
Recruiting
Intensive care, University Hospital, Rouen
Rouen
Grégoire JOLLY
Grégoire JOLLY
Not yet recruiting
Intensive care, University Hospital, Saint Brieuc
Saint-Brieuc
François LEGAY
François LEGAY
Recruiting
Intensive care, University Hospital, Saint Nazaire
Saint-Nazaire
Patricia COUROUBLE
Patricia COUROUBLE
Recruiting
Intensive care, University Hospital, Strasbourg
Strasbourg
Julien DEMISELLE
Julien DEMISELLE
Not yet recruiting
Intensive care, University Hospital, Strasbourg
Strasbourg
Jean-Etienne HERBRECHT
Jean-Etienne HERBRECHT
Not yet recruiting
Intensive care, University Hospital, Tours
Tours
Stephan EHRMANN
Stephan EHRMANN
Recruiting

Other trials in France

About this study

Official title: Awake Prone Positioning of Patients Suffering Community Acquired Pneumonia Requiring Nasal High Flow Therapy, Excluding COVID-19

Among invasively mechanically ventilated patients with ARDS and presenting a PaO2/FiO2 ratio (arterial partial pressure of oxygen to inspired fraction of oxygen) of less than 150 mmHg, the prone position significantly reduces mortality and represents standard care (Guérin 2013). Among non-intubated COVID-19 patients, a subtype of viral community acquired pneumonia, a recent study showed that awake prone positioning reduces the composite outcome of intubation or death among patients requiring nasal high flow therapy. Furthermore, it favored weaning of nasal high flow therapy.

Prone position in patients with non-COVID ARDS treated with high nasal flow was evaluated in 20 patients with predominantly viral pneumonia (Ding 2020) and was associated with improved oxygenation.

Coordinating investigator hypothesize that prone positioning of patients suffering non-COVID community acquired pneumonia and undergoing nasal high flow therapy can significantly improve outcome by reducing the need for intubation and associated therapies such as sedation and muscle relaxation.

Conditions: Community-acquired Pneumonia
Being tested: Prone position
Medical subject headings: Community-Acquired Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prone positionOther
depending on tolerance, the objective is to spend as much time as possible, up to 16h and beyond, in prone position per period of 24 hours. For each session the patients will be encouraged to stay as long as possible in the prone position (i.e. ideally 4-8 hours each session).

Study groups in NCT06966310
Study group	Role	What they receive
Prone position group	Experimental	patients will be invited and assisted to prone as long as possible every day. The goal is to achieve at least 8h in the prone position per 24h period, with 3-6 prone sessions. Receives: Other: Prone position
Control group	No intervention	Usual care including nasal high flow therapy adapted for a SpO2 of 92-95%. No prone positioning.

What is being measured

The primary outcome is the main question the study is designed to answer.

Intubation within 28 days of randomization
Analyzed in a competing risk framework with death and intensive care unit discharge taken into account as competing events.
Measured: From randomization to day 28

Secondary outcomes (17)

Patient comfort before the first prone session, using a visual analogue scale.
A scale from 0 to 10, where 0 means total discomfort and 10 means optimal comfort.
Measured: From randomization to 6 hours
Patient comfort during the first prone session, using a visual analogue scale.
A scale from 0 to 10, where 0 means total discomfort and 10 means optimal comfort.
Measured: From randomization to day 1
Patient comfort after the first prone session, using a visual analogue scale.
A scale from 0 to 10, where 0 means total discomfort and 10 means optimal comfort.
Measured: From randomization to day 1
Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) before the first prone session for patients in the intervention group.
Measured: From randomization to 6 hours
Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) during the first prone session for patients in the intervention group.
Measured: From randomization to day 1
Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) after the first prone session for patients in the intervention group.
Measured: From randomization to day 1
Daily patient comfort comparison between groups from day 1 to day 3, using a visual analogue scale.
Measured: From day 1 to day 3
Oxygenation (PaO2/FiO2 ratio and ROX index) daily comparison between groups from day 1 to day 3.
Measured: From day 1 to day 3
Time to treatment escalation to non-invasive ventilation or continuous positive airway pressure (CPAP) with intubation or death as competing events (up to day 28 or intensive care unit discharge whichever occurs first).
Measured: From randomization to day 28 or intensive care unit discharge whichever occurs first
Time to successful weaning of nasal high flow with intubation or death as competing events (up to day 28 or intensive care unit discharge whichever occurs first).
Measured: From randomization to day 28 or intensive care unit discharge whichever occurs first
Time to intensive care unit discharge and time to hospital discharge (up to day 28).
Measured: From randomization to day 28
Mortality
Measured: From randomization to day 90
Mortality
Measured: From randomization to day 28 or intensive care unit and hospital discharge
Nursing workload: time spent in the patient room by nursing staff during the 24 hours post randomization in both groups
measured as person.hours
Measured: From randomization to 24 hours post randomization
Evolution of patient's quality of life
using the EQ-5D-5L questionnaire. The response is given on 5-point scales (1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: extreme problems or total inability)
Measured: At 90 days
Evolution of patient's quality of life
using the EQ-5D-5L questionnaire. The response is given on 5-point scales (1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: extreme problems or total inability)
Measured: At 5 years
Safety: skin lesions, lines dislodgement, central line infection, vomiting, (up to day 28 or intensive care unit discharge whichever occurs first).
Measured: From randomization to day 28 or intensive care unit discharge whichever occurs first).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 2025Oct 2034

First posted11 May 2025
Study start30 Nov 2025
Primary completionNov 2029 (estimated)
Study completionOct 2034 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
More trials run by University Hospital, ToursThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,078 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06966310
Sponsor's protocol ID: DR230003
Acronym: PRONECAP
Status last verified: Apr 2026
First submitted: 2 May 2025
Last updated: 4 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Stephan EHRMANN

2.47.47.38.55 ext. +33

stephanehrmann@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
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Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
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All Community-acquired Pneumonia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Awake Prone Positioning of Patients Suffering Community Acquired Pneumonia Requiring Nasal High Flow Therapy, Excluding COVID-19
ClinicalTrials.gov ID: NCT06966310
Acronym / sponsor ID: PRONECAP / DR230003
Conditions: Community-acquired Pneumonia
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 1,078 participants (estimated)
Lead sponsor: University Hospital, ToursUniversity, hospital or other
Study start: 30 Nov 2025 (actual)
Primary completion: Nov 2029 (estimated)
Study completion: Oct 2034 (estimated)
First posted: 11 May 2025 (actual)
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.

Prone position in patients with non-COVID ARDS treated with high nasal flow was evaluated in 20 patients with predominantly viral pneumonia (Ding 2020) and was associated with improved oxygenation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Prone position group	Experimental	Other: Prone positionpatients will be invited and assisted to prone as long as possible every day. The goal is to achieve at least 8h in the prone position per 24h period, with 3-6 prone sessions.
Control group	No intervention	–Usual care including nasal high flow therapy adapted for a SpO2 of 92-95%. No prone positioning.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Adult patients admitted to an intensive care unit or intermediate care unit
Suspicion of community acquired pneumonia (at least one of the 3 criteria): fever, cough, purulent expectoration
And abnormalities suggestive of pneumonia by chest X-ray or CT-scan
PaO2/FiO2 ratio <300 mmHg (or equivalent SpO2/FiO2 i.e. < 315 mmHg) under a minimum gas flow of 30 L/min.
Person affiliated to a French social security system or equivalent

Key exclusion criteria (9 listed)

Positive SARS-COV2 test within the last 30 days
Indication for immediate intubation
Patients for whom a "do not intubate" decision has been made
Chest trauma or other contraindication to prone position
Patients with formal indication for non-invasive ventilation: exacerbation of chronic obstructive pulmonary disease, acute cardiogenic pulmonary oedema.

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
Prone positiondepending on tolerance, the objective is to spend as much time as possible, up to 16h and beyond, in prone position per period of 24 hours. For each session the patients will be encouraged to stay as long as possible in the prone position (i.e. ideally 4-8 hours each session).	Other	Prone position group

Primary outcome

Intubation within 28 days of randomization
Time frame: From randomization to day 28
Analyzed in a competing risk framework with death and intensive care unit discharge taken into account as competing events.

17 secondary outcomes

Patient comfort before the first prone session, using a visual analogue scale.
Time frame: From randomization to 6 hours
Patient comfort during the first prone session, using a visual analogue scale.
Time frame: From randomization to day 1
Patient comfort after the first prone session, using a visual analogue scale.
Time frame: From randomization to day 1
Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) before the first prone session for patients in the intervention group.
Time frame: From randomization to 6 hours
Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) during the first prone session for patients in the intervention group.
Time frame: From randomization to day 1
Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) after the first prone session for patients in the intervention group.
Time frame: From randomization to day 1
Daily patient comfort comparison between groups from day 1 to day 3, using a visual analogue scale.
Time frame: From day 1 to day 3
Oxygenation (PaO2/FiO2 ratio and ROX index) daily comparison between groups from day 1 to day 3.
Time frame: From day 1 to day 3
Time to treatment escalation to non-invasive ventilation or continuous positive airway pressure (CPAP) with intubation or death as competing events (up to day 28 or intensive care unit discharge whichever occurs first).
Time frame: From randomization to day 28 or intensive care unit discharge whichever occurs first
Time to successful weaning of nasal high flow with intubation or death as competing events (up to day 28 or intensive care unit discharge whichever occurs first).
Time frame: From randomization to day 28 or intensive care unit discharge whichever occurs first
Time to intensive care unit discharge and time to hospital discharge (up to day 28).
Time frame: From randomization to day 28
Mortality
Time frame: From randomization to day 90
Mortality
Time frame: From randomization to day 28 or intensive care unit and hospital discharge
Nursing workload: time spent in the patient room by nursing staff during the 24 hours post randomization in both groups
Time frame: From randomization to 24 hours post randomization
Evolution of patient's quality of life
Time frame: At 90 days
Evolution of patient's quality of life
Time frame: At 5 years
Safety: skin lesions, lines dislodgement, central line infection, vomiting, (up to day 28 or intensive care unit discharge whichever occurs first).
Time frame: From randomization to day 28 or intensive care unit discharge whichever occurs first).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.

Related trials for Community-acquired Pneumonia

Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
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Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
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Active, not recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
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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.

Stephan EHRMANN contact

2.47.47.38.55 ext. +33

stephanehrmann@gmail.com

Stephan EHRMANN study director

University Hospital, Tours

38 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Prone position in people with Community-acquired Pneumonia, run by University Hospital, Tours at 38 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stephan EHRMANN (2.47.47.38.55 ext. +33, stephanehrmann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intubation within 28 days of randomization (time frame: From randomization to day 28). 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 NCT06966310.

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 4 May 2026.