Ventilator-Associated Pneumonia (VAP)POSTPONENCT06743529
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
A study testing Conservative strategy in people with Ventilator-Associated Pneumonia (VAP), run by Nantes University Hospital at 42 sites in 2 countries.
Trial summary
Ventilator-associated pneumonia is the leading nosocomial infection in the intensive care units, and is associated with prolonged mechanical ventilation and overuse of antibiotics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-Associated Pneumonia (VAP)
- What is being tested?
- Conservative strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 686 participants
- Where
- 42 sitesin 2 countries
- Study dates
- 11 Nov 2025to 11 Feb 2029
- 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
- Invasive mechanical ventilation for longer than 48 hours
- Respiratory sample collection taken less than two hours ago (at physician discretion, according to local protocol) for a first episode of suspected ventilator-associated pneumonia (meeting the following prespecified criteria) :
- new or changing chest X-ray infiltrates
- plus at least two of the following:
- body temperature ≥38°C or ≤35.5°C,
- blood leukocyte count >12 000/µL or <4000/µL,
Show all 29Show fewer
- purulent tracheobronchial aspirate.
- Age ≥18 years
- Informed consent from the patient or next of kin to participation in the trial, or emergency procedure if no next of kin is available
- Patients affiliated to a social security system
- Non-inclusion Criteria:
- Criteria for severe ventilator-associated pneumonia defined as:
- Vasopressor therapy for onset of septic shock around the time of ventilator-associated pneumonia suspicion
- Onset or severe worsening of hypoxemia (PaO2/FiO2<150 with 60% FiO2 and 10 mm H2O peak expiratory pressure, or patient on veno-venous extracorporeal membrane oxygenation)
- Immunosuppression defined as :
- leukocytes <1G/L or neutrophils <0,5 G/L
- within the last 3 months
- hematopoietic stem-cell transplant or organ transplant with chronic immunosuppressant therapy
- HIV infection with CD4<50/mm3
- chronic corticosteroid use (>0.5 mg/kg day for at least one month within the last three months).
- Patient already on Antibiotic Therapy of predicted duration ≥4 weeks (endocarditis, spondylodiscitis, abscess...)
- Previous ventilator-associated pneumonia suspicion with sampling and/or Antibiotic Therapy for suspected ventilator-associated pneumonia
- Previous inclusion in the trial
- Patient included in an interventional study on ventilator-associated pneumonia management with the same primary endpoint.
- Pregnancy, recent delivery, or breastfeeding
- Correctional facility inmate, adult under guardianship
- Patient under legal protection
- Life expectancy less than 48 h and/or decision not to treat potential pneumonia acquired under mechanical ventilation in the context of limiting/discontinuing treatment.
- Organ donor reanimation
Who cannot join
None listed.
Trial locations and contacts
42 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
42 sites in 2 countries
France41 sites, 41 recruiting
- Recruiting
CHU Angers
Angers, France, 49000
Achillle KOUATCHET, 02 41 35 38 15 ext. +33, ackouatchet@chu-angers.fr
- Recruiting
CH Angoulème
Angoulème, France, 16000
Laurent LAINE, 09 51 49 71 81 ext. +33, laurent.laine@ch-angouleme.fr
- Recruiting
CH Argenteuil
Argenteuil, France, 95100
Gaétan PLANTEFEVE, 01 34 23 25 50 ext. +33, gaetan.plantefeve@ch-argenteuil.fr
- Recruiting
CH d'Arles
Arles, 13637
Florent MONTINI, PH, 0490492988, florent.moniti@ch-arles.fr
- Recruiting
CH Avignon
Avignon, 84000
Gael PRADEL, 04 32 75 34 61 ext. +33, pradel.gael@ch-avignon.fr
- Recruiting
Hôpital Nord Franche Comté
Belfort, 90000
Hakim SLIMANI, 03 84 98 21 91 ext. + 33, hakim.slimani@hnfc.fr
- Recruiting
CHU de Bordeaux
Bordeaux, 33076
Arthur ORIEUX, PH, 05 56 79 55 17, arthur.orieux@chu-bordeaux.fr
- Recruiting
CHU de Bordeaux
Bordeaux
Charline SAZIO, PH, 05 56 79 56 79, charline.sazio@chu-bordeaux.fr
- Recruiting
CH Simone Veil
Cannes, 06414
Pierre-Marie BERTRAND, 04 93 69 78 51 ext. +33, pm.bertrand@ch-cannes.fr
- Recruiting
CH Public du Cotentin
Cherbourg, 50102
Julien CALUS, 02 33 20 76 80 ext. +33, julien.calus@ch-cotentin.fr
- Recruiting
CH Cholet
Cholet, 49325
Julien DUPEYRAT, julien.dupeyrat@ch-cholet.fr
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Claire DUPUIS, 04 73 75 44 92 ext. +33, cdupuis@chuclermontferrand.fr
- Recruiting
CH Dax
Dax, 40107
Adrien AUVET, 05 58 90 55 44 ext. +33, auveta@ch-dax.fr
- Recruiting
CHU Dijon
Dijon, 21033
Jean-Pierre QUENOT, 03.80.29.36.85 ext. +33, jean-pierre.quenot@chudijon.fr
- Recruiting
APHP - Hôpital Raymond Poincaré
Garches, 92380
Pierre MOINE, 01 47 10 77 78 ext. +33, pierre.moine@aphp.fr
- Recruiting
CHD Vendée
La Roche-sur-Yon, 85025
Samuel GENSBURGER, 02 51 44 60 26 ext. +33, samuel.gensburger@ght85.fr
- Recruiting
CH Versailles
Le Chesnay, 78157
Alexis FERRE, 01 39 63 87 00 ext. +33, aferre@ght78sud.fr
- Recruiting
CH Le Mans
Le Mans, 72000
Juliette MEUNIER, 02 43 43 24 58 ext. +33, jmeunier@ch-lemans.fr
- Recruiting
CH Emile Roux
Le Puy-en-Velay, 43000
Achille SOSSOU, PH, 04 71 04 38 51, achille.sossou@ch-lepuy.fr
- Recruiting
CHRU Lille
Lille, 59037
Anahita ROUZE, 03 20 44 50 94 ext. +33, anahita.rouze@chru-lille.fr
- Recruiting
GHB Sud- Hôpital de Lorient
Lorient, 56100
Pierre BOUJU, 02 97 06 75 14 ext. +33, p.bouju@ghbs.bzh
- Recruiting
CHU de Lyon - Hôpital Edouard Herriot
Lyon, 69437
Laurent ARGAUD, 04 72 11 28 62 ext. +33, laurent.argaud@chulyon.fr
- Recruiting
Hôpital Européen Marseille
Marseille
Jean ALPHONSINE, PH, 0413423657, j.alphonsine@hopital-europeen.fr
- Recruiting
CH de Melun
Melun, 77000
Simon BOURSIER, PH, 01 81 74 0 77, simon.boursier@ghsif.fr
- Recruiting
CH de Mont de Marsan
Mont-de-Marsan, 40000
Arnaud DELAHAYE, 05 58 05 11 15 ext. +33, arnaud.delahaye@ch-mdm.fr
- Recruiting
CHU Nantes
Nantes, France, 44000
Maëlle MARTIN, 0240 087 365 ext. + 33, maelle.martin@chu-nantes.fr
- Recruiting
CHU Nice -Hôpital Pasteur
Nice, 06100
Alexandre ROBERT, 04 92 03 36 22 ext. +33, robert.a@chu-nice.fr
- Recruiting
CHU Nice - Hôpital de l'Archet
Nice, 06200
Clément SACCHERI, 04 92 03 55 10 ext. +33, saccheri.c@chu-nice.fr
- Recruiting
CHR d'Orléans
Orléans, 45100
Maxime DESGROUAS, 02 38 65 13 17 ext. +33, maxime.desgrouas@chr-orleans.fr
- Recruiting
APHP - Hôpital Cochin
Paris, 75014
Julien CHARPENTIER, 01 58 41 25 17 ext. +33, julien.charpentier@aphp.fr
- Recruiting
APHP - Hôpital Tenon
Paris, 75020
Alexandra BEURTON, 01 56 01 65 72 ext. +33, alexandra.beurton@aphp.fr
- Recruiting
CH de Pau
Pau, 64000
Stanislas DE GUILLEBON, 05 59 92 48 49 ext. +33, stanislas.deguillebon@ch-pau.fr
- Recruiting
CHU Rennes
Rennes, 35033
Nicolas TERZI, 04 76 76 71 09 ext. +33, nicolas.terzi@churennes.fr
- Recruiting
CH de Saint-Nazaire
Saint-Nazaire, 44600
Faustine REYNAUD, PH, 02 72 27 80 07 ext. +33, f.reynaud@ch-saintnazaire.fr
- Recruiting
CH de Saint-Malo
St-Malo, 35403
Nicolae-Vlad BOTOC, 02 99 21 21 21 ext. +33, v.botoc@ch-stmalo.fr
- Recruiting
CHRU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, 67091
Antoine STUDER, 03 69 55 10 23 ext. +33, antoine.studer@chru-strasbourg.fr
- Recruiting
CHRU de Strasbourg -Hôpital de Hautepierre
Strasbourg, 67098
Vincent CASTELAIN, 03 88 12 82 69 ext. +33, vincent.castelain@chru-strasbourg.fr
- Recruiting
Hôpital Foch
Suresnes, 92150
Jérôme DEVAQUET, 01 46 25 24 74 ext. +33, j.devaquet@hopital-foch.com
- Recruiting
CHRU De Tours
Tours, 37044
Denis GAROT, 02 47 47 37 18 ext. +33, d.garot@chu-tours.fr
- Recruiting
CH de Valenciennes
Valenciennes, 59300
Fabien LAMBIOTTE, 03 27 14 30 70 ext. +33, lambiotte-f@ch-valenciennes.fr
- Recruiting
CH Bretagne Atlantique
Vannes, 56017
Agathe DELBOVE, 02 97 01 43 06 ext. +33, agathe.delbove@ch-bretagne-atlantique.fr
Guadeloupe1 site, 1 recruiting
- Recruiting
CHU La Guadeloupe
Pointe-à-Pitre, 97159
Laurent CAMOUS, 05 90 89 20 34 ext. +33, laurent.camous@chuguadeloupe.fr
About this study
Official title: Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia: A Randomized Controlled Trial
Ventilator-associated pneumonia is the leading nosocomial infection in the intensive care units, and is associated with prolonged mechanical ventilation and overuse of antibiotics. Initiating antibiotic therapy immediately after bacteriological sampling (immediate strategy) may expose uninfected patients to unnecessary treatment, while waiting for bacteriological confirmation (conservative strategy) may delay ventilator-associated pneumonia in infected patients.
The decision to start antibiotic therapy for ventilator-associated pneumonia takes three points into account: diagnostic probability, the risks to the patient if Antibiotic Therapy is delayed, and the risk of selection of resistant bacteria. Diagnostic probability is limited, given the subjective and non-specific nature of the diagnostic criteria, and only 30-50% of suspected cases are confirmed bacteriologically (whereas samples are only taken when the pre-test probability is sufficient). The risks associated with delayed antibiotic therapy are unknown, as few observational studies have directly assessed the impact of the timing of Antibiotic Therapy initiation on outcome (frequent confusion between delayed and inappropriate Antibiotic Therapy).
Read more
Iregui et al. found that delaying Antibiotic Therapy by more than 24 hours was associated with higher mortality. However, more recent before-and-after studies have shown that the conservative strategy was associated with lower mortality, more frequently appropriate initial Antibiotic Therapy and shorter duration of Antibiotic Therapy. Similarly, in a recent before-and-after study by our team, initiating antibiotic therapy only upon microbiological confirmation of ventilator-associated pneumonia without septic shock or severe acute respiratory distress syndrome was not associated with an increase in ventilation time, length of stay or excess mortality at D28; but was associated with antibiotic therapy that was more often appropriate (DELAVAP, MARTIN et al, Annals of Intensive Care, 2024). Finally, the recent multicenter TARPP pilot study in surgical intensive care suggests that antibiotic therapy initiated on the basis of microbiological data in patients with suspected ventilator-associated pneumonia not requiring vasopressor support is not associated with a poorer outcome than immediate antibiotic therapy without documentation (the only randomized study on this subject).
Antibiotic Therapy for suspected ventilator-associated pneumonia that is not subsequently confirmed is an unnecessary use of antibiotics and carries a risk of selection of resistant bacteria, with adverse effects on public health. It has been reported that a conservative Antibiotic Therapy prescription strategy for intensive care units -acquired infections reduces Antibiotic Therapy use and the incidence of acquired β-lactamase-producing Enterobacteriaceae infections.
Overall, in patients with suspected ventilator-associated pneumonia but no signs of clinical severity, given the uncertainty about attributable mortality and concerns about bacterial resistance, the evaluation of the conservative Antibiotic Therapy strategy is reasonable. Some French intensive care units already delay Antibiotic Therapy until confirmation of ventilator-associated pneumonia, except in patients with severe hypoxemia or the need for vasopressor support.
- Conditions
- Ventilator-Associated Pneumonia (VAP)
- Being tested
- control group, Conservative strategy
- Keywords
- Intensive care medicine, Intensive care, Ventilator-associated pneumonia, antibiotic sparing
- 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.
control groupProcedure or surgery
immediate empiric Antibiotic Therapy (started within 1 hour after randomization) with antibiotic(s) chosen by the bedside physician based on time of ventilator-associated pneumoniaoccurrence, risk of antimicrobial resistance, local ecology, and local protocol. If the respiratory samples are negative, Antibiotic Therapy will be stopped. If ventilator-associated pneumonia is confirmed by positive samples, Antibiotic Therapy active against the recovered bacterial specie(s) will be given for a total of 7 days.
Conservative strategyProcedure or surgery
No Antibiotic Therapy until receipt of the respiratory sample culture and/or polymerase chain reaction results. If these results are negative, no Antibiotic Therapy is given. If they are positive (confirmed ventilator-associated pneumonia), Antibiotic Therapy is started as appropriate for the bacterial specie(s) detected by culture and/or polymerase chain reaction, without considering gram-stain results and without waiting for antimicrobial susceptibility testing results, and continued for a total of 7 days of Antibiotic Therapy active against the identified bacterial specie(s).
| Study group | Role | What they receive |
|---|---|---|
| Immediate strategy | Active comparator | Usual Care Receives: Procedure: control group |
| Conservative strategy | Experimental | Conservative strategy Receives: Procedure: Conservative strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who die whithin 28 days or are still on invasive mechanical ventilation on day 28
To assess, in intensive care units patients with suspected nonsevere ventilator-associated pneumonia (no septic shock or severe acute respiratory distress syndrome), whether delaying antibiotic therapy until ventilator-associated pneumonia is confirmed by a positive respiratory-sample culture and/or polymerase chain reaction test (conservative strategy) neither increases day-28 mortality nor prolongs invasive mechanical ventilation , compared to antibiotic therapy initiation immediately after sampling (immediate strategy).
Measured: From day 0 to day 28
Secondary outcomes (31)
Sequential Organ Failure Assessment (SOFA) score
Daily Sequential Organ Failure Assessment (SOFA)
Measured: From day 0 to day 7
Modified clinical pulmonary infection score (mCPIS)
Daily mcPIS
Measured: From day 0 to day 7
Clinical cure
Clinical cure is defined as the combination of resolution of signs and symptoms present at enrollment, and improvement or lack of progression of radiological signs
Measured: day 7
Invasive mechanical ventilation duration
Days of invasive mechanical ventilation
Measured: From day 0 to day 28
Ventilator free days
Measured: From day 0 to day 28
Use of vasopressors
Days on vasopressors
Measured: From day 0 to day 28
Use of renal replacement therapy
Days on renal replacement therapy
Measured: From day 0 to day 28
Mortality rates
ICU discharge mortality rates
Measured: ICU discharge, an average of 10 days
Mortality rates
Mortality rates at day 28
Measured: day 28
Mortality rates
Mortality rates at day 90
Measured: day 90
Mortality rates
Mortality rates at hospital discharge
Measured: Hospital discharge, an average of 20 days
ICU stay lenghts
ICU stay lenghts (days)
Measured: From day 0 until the day of discharge from ICU, an average of 10 days
Hospital stay lenghts
Hospital stay lenghts (days)
Measured: From day 0 until the day of discharge from Hospital, an average of 20 days
Incidence of ventilator associated pneumonia related abscess
Measured: From day 0 until the day of discharge from ICU, an average of 10 days
Incidence of ventilator associated pneumonia related bacteria
Measured: From day 0 until the day of discharge from ICU, an average of 10 days
Incidence and timing of subsequent ventilator associated pneumonia during the hospital stay
Incidence and timing of subsequent ventilator associated pneumonia during the hospital stay: relapse, recurrence, superinfection, ventilator associated pneumonia occurrence after a suspected but refuted ventilator associated pneumonia episode; recurrence is defined as improvements in manifestations (fever, secretions, vasopressor needs, inflammatory biomarkers, and chest radiograph infiltrates) after 7 days' treatment with at least ne antibiotic active on all documented bacteria, followed by the return or worsening of these manifestations with a new respiratory sample (culture, with or without PCR) positive for at least one bacterial species in significant concentrations; the same scenario with a respiratory sample positive for at least one of the initial causative bacteria defined relapse; no improvement in manifestations after 7 days' active treatment with a respiratory sample positive for at least one of the initial causative bacteria defined superinfection.
Measured: From day 0 until the day of discharge from Hospital, an average of 20 days
Incidence of noscomial infections between randomisation and hospital discharge
Nosocomial infections including ventilator asssociated pneumonia, nosocomial pneumonia, bacteremia, catheter-related bloodstream infection, urinary-tract infection, soft-tissue infection, C. difficile infection, and other infections
Measured: From day 0 until the day of discharge from Hospital, an average of 20 days
Incidence of in-hospital nosocomial infections by multiresistant bacteria (MRB)
Defined as any of the following: methicillin-resistant Staphylococcus aureus (MRSA), glycopeptide-intermediate S. aureus (GISA), vancomycin-resistant Enterococcus (VRE), extended-spectrum beta-lactamase-producing Enterobacterales (ESBL-e), carbapenemase-producing Enterobacterales (CPE), and imipenem-resistant Acinetobacter baumannii (IRAB).
Measured: From day 0 until the day of discharge from Hospital, an average of 20 days
Incidences of allergies and of diarrhea
Measured: From day 0 until the day of discharge from Hospital, an average of 20 days
Antibiotic-free days
Measured: day 10
Number of antibotic therapy days by day 28
computed as days of therapy (DOT), defined as the number of days on AT, with each day multiplied by the number of individual antimicrobial agents given on that day, irrespective of the number of doses given.
Measured: day 28
Broad-spectrum days of therapy (DOT) by day 28
(ceftazidime, piperacillin/tazobactam, cefepime, fluoroquinolones, carbapenems, or new AT for multidrug-resistant Gram-negative bacilli) (number of days on broad-spectrum AT multiplied by the number of individual antimicrobial agents given on each of those days, irrespective of the number of doses given)
Measured: day 28
Carbapenom days of therapy (DOT) by day 28
Carbapenem DOT by day 28 (number of calendar days during which the patient received at least one carbapenem dose multiplied by the number of individual antimicrobial agents given on each of those days, until day 28, irrespective of the number of doses given).
Measured: day 28
Ventilator associated pneumonia antibiotic therapy
Descriptive data : dual therapy, median time from respiratory sampling to AT, duration, de-escalation (defined as empirical AT stopped or number of empirical antimicrobials decreased or spectrum of empirical AT narrowed, based on AST results)
Measured: From day 0 to day 28
Descriptive antibiotic therapy data
Ventilator associated pneumonia antibiotic therapy: antimicrobial(s), dual therapy, median time from respiratory sampling to antibiotic therapy, duration, de-escalation (defined as empirical AT stopped or number of empirical antimicrobials decreased or spectrum of empirical antibiotic therapy narrowed, based on AST results) , antibiotic therapy for reasons other than suspected VAP: antimicrobial, duration, reason
Measured: From day 0 to day 28
Descriptive bacteriological data
gram stain, organisms recovered (cultured and/or identified by PCR), and antimicrobial resistance profiles
Measured: From day 0 to day 28
Descriptive clinical, laboratory and radiological data 48 hours before ventilator associated pneumonia suspicion
Measured: 48 hours before ventilator asociated pneumonia suspicion
Proportion of patients with confirmed ventilator associated pneumonia
Measured: From day 0 to day 28
Number of patients given active/inactive/unnecessary antibiotic therapy on day 0 and on the day of antibiotic therapy initiation
Number of patients given active/inactive/unnecessary antibiotic therapy on day 0 and on the day of antibiotic therapy initiation (with active defined as at least one antimicrobial agent active against each bacterial species isolated from respiratory samples in concentrations greater than prespecified thresholds, based on AST; inactive defined as not meeting criteria for active AT; and unnecessary defined as antibiotic therapy given before sample results with these being negative)
Measured: Day 0 and on the day of antibiotic therapy initiation, an average of 1 day
Number of patients with suitable antibotic therapy (defined as active antibiotic therapy or spared antibiotic therapy as defined below) on day 0 and on the day of antibiotic therapy initiation in the conservative strategy arm
- Number of patients given substantiated antibotic therapy defined as started upon receipt of positive respiratory-sample culture and/or PCR test results
- Number of patients given rescue antibotic therapy defined as started, in a conservative group patient, after sampling but before culture and/or PCR results, due to the development of ventilator associated pneumonia severity criteria (shock or severe ARDS)
- Number of patients spared antibotic therapy for the suspected ventilator associated pneumonia episode, that is, not given antibotic therapy after sampling and having negative respiratory-sample results
Measured: Day 0 and on the day of antibiotic therapy initiation, until discharge from intensive care unit or up to 28 days
Incremental cost-utility ratio (ICUR)
The incremental cost-utility ratio (ICUR, cost per quality-adjusted life year [QALY] gained) of the two strategies will be computed from a collective perspective and with a 90-day time horizon then compared between the two groups.
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start11 Nov 2025
- Primary completion11 Dec 2028 (estimated)
- Study completion11 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Associated Pneumonia (VAP)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 686 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743529
- Sponsor's protocol ID
- RC24_0466
- Acronym
- POSTPONE
- Status last verified
- Oct 2026
- First submitted
- 10 Dec 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06743529
- Acronym / sponsor ID
- POSTPONE / RC24_0466
- Conditions
- Ventilator-Associated Pneumonia (VAP)
- Keywords
- Intensive care medicine, Intensive care, Ventilator-associated pneumonia, antibiotic sparing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 686 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 11 Dec 2028 (estimated)
- Study completion
- 11 Feb 2029 (estimated)
- First posted
- 20 Dec 2024 (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.
Ventilator-associated pneumonia is the leading nosocomial infection in the intensive care units, and is associated with prolonged mechanical ventilation and overuse of antibiotics. Initiating antibiotic therapy immediately after bacteriological sampling (immediate strategy) may expose uninfected patients to unnecessary treatment, while waiting for bacteriological confirmation (conservative strategy) may delay ventilator-associated pneumonia in infected patients.
The decision to start antibiotic therapy for ventilator-associated pneumonia takes three points into account: diagnostic probability, the risks to the patient if Antibiotic Therapy is delayed, and the risk of selection of resistant bacteria. Diagnostic probability is limited, given the subjective and non-specific nature of the diagnostic criteria, and only 30-50% of suspected cases are confirmed bacteriologically (whereas samples are only taken when the pre-test probability is sufficient). The risks associated with delayed antibiotic therapy are unknown, as few observational studies have directly assessed the impact of the timing of Antibiotic Therapy initiation on outcome (frequent confusion between delayed and inappropriate Antibiotic Therapy).
Iregui et al. found that delaying Antibiotic Therapy by more than 24 hours was associated with higher mortality. However, more recent before-and-after studies have shown that the conservative strategy was associated with lower mortality, more frequently appropriate initial Antibiotic Therapy and shorter duration of Antibiotic Therapy. Similarly, in a recent before-and-after study by our team, initiating antibiotic therapy only upon microbiological confirmation of ventilator-associated pneumonia without septic shock or severe acute respiratory distress syndrome was not associated with an increase in ventilation time, length of stay or excess mortality at D28; but was associated with antibiotic therapy that was more often appropriate (DELAVAP, MARTIN et al, Annals of Intensive Care, 2024). Finally, the recent multicenter TARPP pilot study in surgical intensive care suggests that antibiotic therapy initiated on the basis of microbiological data in patients with suspected ventilator-associated pneumonia not requiring vasopressor support is not associated with a poorer outcome than immediate antibiotic therapy without documentation (the only randomized study on this subject).
Antibiotic Therapy for suspected ventilator-associated pneumonia that is not subsequently confirmed is an unnecessary use of antibiotics and carries a risk of selection of resistant bacteria, with adverse effects on public health. It has been reported that a conservative Antibiotic Therapy prescription strategy for intensive care units -acquired infections reduces Antibiotic Therapy use and the incidence of acquired β-lactamase-producing Enterobacteriaceae infections.
Overall, in patients with suspected ventilator-associated pneumonia but no signs of clinical severity, given the uncertainty about attributable mortality and concerns about bacterial resistance, the evaluation of the conservative Antibiotic Therapy strategy is reasonable. Some French intensive care units already delay Antibiotic Therapy until confirmation of ventilator-associated pneumonia, except in patients with severe hypoxemia or the need for vasopressor support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate strategy | Active comparator | Procedure: control groupUsual Care |
| Conservative strategy | Experimental | Procedure: Conservative strategyConservative strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Invasive mechanical ventilation for longer than 48 hours
- Respiratory sample collection taken less than two hours ago (at physician discretion, according to local protocol) for a first episode of suspected ventilator-associated pneumonia (meeting the following prespecified criteria) :
- Age ≥18 years
- Informed consent from the patient or next of kin to participation in the trial, or emergency procedure if no next of kin is available
- Patients affiliated to a social security system
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| control groupimmediate empiric Antibiotic Therapy (started within 1 hour after randomization) with antibiotic(s) chosen by the bedside physician based on time of ventilator-associated pneumoniaoccurrence, risk of antimicrobial resistance, local ecology, and local protocol. If the respiratory samples are negative, Antibiotic Therapy will be stopped. If ventilator-associated pneumonia is confirmed by positive samples, Antibiotic Therapy active against the recovered bacterial specie(s) will be given for a total of 7 days. | Procedure or surgery | Immediate strategy |
| Conservative strategyNo Antibiotic Therapy until receipt of the respiratory sample culture and/or polymerase chain reaction results. If these results are negative, no Antibiotic Therapy is given. If they are positive (confirmed ventilator-associated pneumonia), Antibiotic Therapy is started as appropriate for the bacterial specie(s) detected by culture and/or polymerase chain reaction, without considering gram-stain results and without waiting for antimicrobial susceptibility testing results, and continued for a total of 7 days of Antibiotic Therapy active against the identified bacterial specie(s). | Procedure or surgery | Conservative strategy |
Primary outcome
Proportion of patients who die whithin 28 days or are still on invasive mechanical ventilation on day 28
Time frame: From day 0 to day 28
To assess, in intensive care units patients with suspected nonsevere ventilator-associated pneumonia (no septic shock or severe acute respiratory distress syndrome), whether delaying antibiotic therapy until ventilator-associated pneumonia is confirmed by a positive respiratory-sample culture and/or polymerase chain reaction test (conservative strategy) neither increases day-28 mortality nor prolongs invasive mechanical ventilation , compared to antibiotic therapy initiation immediately after sampling (immediate strategy).
31 secondary outcomes
Sequential Organ Failure Assessment (SOFA) score
Time frame: From day 0 to day 7
Modified clinical pulmonary infection score (mCPIS)
Time frame: From day 0 to day 7
Clinical cure
Time frame: day 7
Invasive mechanical ventilation duration
Time frame: From day 0 to day 28
Ventilator free days
Time frame: From day 0 to day 28
Use of vasopressors
Time frame: From day 0 to day 28
Use of renal replacement therapy
Time frame: From day 0 to day 28
Mortality rates
Time frame: ICU discharge, an average of 10 days
Mortality rates
Time frame: day 28
Mortality rates
Time frame: day 90
Mortality rates
Time frame: Hospital discharge, an average of 20 days
ICU stay lenghts
Time frame: From day 0 until the day of discharge from ICU, an average of 10 days
Hospital stay lenghts
Time frame: From day 0 until the day of discharge from Hospital, an average of 20 days
Incidence of ventilator associated pneumonia related abscess
Time frame: From day 0 until the day of discharge from ICU, an average of 10 days
Incidence of ventilator associated pneumonia related bacteria
Time frame: From day 0 until the day of discharge from ICU, an average of 10 days
Incidence and timing of subsequent ventilator associated pneumonia during the hospital stay
Time frame: From day 0 until the day of discharge from Hospital, an average of 20 days
Incidence of noscomial infections between randomisation and hospital discharge
Time frame: From day 0 until the day of discharge from Hospital, an average of 20 days
Incidence of in-hospital nosocomial infections by multiresistant bacteria (MRB)
Time frame: From day 0 until the day of discharge from Hospital, an average of 20 days
Incidences of allergies and of diarrhea
Time frame: From day 0 until the day of discharge from Hospital, an average of 20 days
Antibiotic-free days
Time frame: day 10
Number of antibotic therapy days by day 28
Time frame: day 28
Broad-spectrum days of therapy (DOT) by day 28
Time frame: day 28
Carbapenom days of therapy (DOT) by day 28
Time frame: day 28
Ventilator associated pneumonia antibiotic therapy
Time frame: From day 0 to day 28
Descriptive antibiotic therapy data
Time frame: From day 0 to day 28
Descriptive bacteriological data
Time frame: From day 0 to day 28
Descriptive clinical, laboratory and radiological data 48 hours before ventilator associated pneumonia suspicion
Time frame: 48 hours before ventilator asociated pneumonia suspicion
Proportion of patients with confirmed ventilator associated pneumonia
Time frame: From day 0 to day 28
Number of patients given active/inactive/unnecessary antibiotic therapy on day 0 and on the day of antibiotic therapy initiation
Time frame: Day 0 and on the day of antibiotic therapy initiation, an average of 1 day
Number of patients with suitable antibotic therapy (defined as active antibiotic therapy or spared antibiotic therapy as defined below) on day 0 and on the day of antibiotic therapy initiation in the conservative strategy arm
Time frame: Day 0 and on the day of antibiotic therapy initiation, until discharge from intensive care unit or up to 28 days
Incremental cost-utility ratio (ICUR)
Time frame: day 90
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 21 Oct 2026.
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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.
42 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative strategy in people with Ventilator-Associated Pneumonia (VAP), run by Nantes University Hospital at 42 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 29 inclusion and 0 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in France, Guadeloupe. 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 Maëlle MARTIN (0240 087 365 ext. +33, maelle.martin@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who die whithin 28 days or are still on invasive mechanical ventilation on day 28 (time frame: From day 0 to day 28). 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 21 Oct 2026.