ClinicalTrials.gg
RecruitingNCT05405491RESPIREUpdated Aug 7, 2026

Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Immunocompromised Patients With Hospital-acquired Pneumonia Requiring Mechanical Ventilation

An interventional study of PCR based strategy and Standard care in Pneumonia, Ventilator-Associated, Pneumonia, Hospital-Acquired and Immunodeficiency, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2023; still recruiting 3 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 80 studies in Pneumonia, Ventilator-Associated with a site in France — 21 open to participants now, 22 under way, 3 of them phase 3. Pneumonia, Ventilator-Associated · France.

Planned enrollment
39th of 47
31 · median 161
Started
2023
with 7 others
No phase
19 of 80
6 open now
Primary completion
2028-03
later than 17 of 21 live
Registered
55th of 80
by date
Lead sponsor
5 of 80
University Hospital, Lille

Among the 80 studies in Pneumonia, Ventilator-Associated with a site in France, this one is the 39th largest by planned enrollment of the 47 interventional ones that give a count, is one of 8 that started in 2023, is one of 19 with no phase, reaches primary completion later than 17 of the 21 other live ones, and was the 55th registered.

Pneumonia, Ventilator-Associated

420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 85 are open to participants now.

Browse Pneumonia, Ventilator-Associated studies →

Open to participants now

21 of the 80 studies in Pneumonia, Ventilator-Associated with a site in France are open now. Recruiting first, the newest first:

15 more — sign in →

All 21 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 48 Pneumonia, Ventilator-Associated studies recruiting now, 37 (77%) set no upper age limit and 6 (13%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

RESPIRE is a randomized, unblinded, controlled study to measure the impact of a strategy based on a PCR test on the adjustment of antimicrobial therapy in immunocompromised patients suspected with ventilator-associated or hospital-acquired pneumonia (VAP/HAP) requiring mechanical ventilation (MV) in Intensive Care Unit (ICU). The gold-standard microbiological diagnostic method for pneumonia in the ICU is based on culture identification and antimicrobial susceptibility testing. Results are obtained in several days after the initiation of empiric antimicrobial therapy, exposing patients to a potential inappropriate broad-spectrum antimicrobial treatment. We aim to measure the impact of a PCR-based strategy to improve the percentage of patients with VAP or HAP receiving targeted antimicrobial therapy 24 hours after diagnosis compared to standard care

03

Conditions studied

  • Pneumonia, Ventilator-Associated
  • Pneumonia, Hospital-Acquired
  • Immunodeficiency

Keywords

  • Ventilator-associated pneumonia
  • Hospital-acquired pneumonia
  • Immunodeficiency
  • Antimicrobial therapy
  • Polymerase chain reaction (PCR)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients hospitalized in ICU with suspected VAP or HAP requiring MV

Exclusion criteria

Exclusion Criteria:

  • No immunodeficiency Moribund patients (SAPS II > 90) Pregnant women Refuse to participate to the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
31 participants (estimated)

Study arms

  • Experimental
    PCR group

    Other: PCR based strategy

  • Sham comparator
    Control group

    Other: Standard care

Interventions

  • OtherPCR based strategy

    Early adjustment of antimicrobial therapy according to the results of a multiplex PCR-based testing, used in addition to standard microbiological culture of the tracheal aspirate, in immunocompromised patients with suspected VAP or HAP requiring MV

  • OtherStandard care

    Broad-spectrum antimicrobial therapy adjustment after results of standard microbiological culture of the tracheal aspirate in immunocompromised patients with suspected VAP or HAP requiring MV

06

What researchers measure

Primary outcomes

  1. Increase in percentage of patients with targeted antibiotics

    To determine the impact of a PCR-based strategy on the increase in percentage of patients with targeted antibiotics regimen 24 hours after starting empiric antimicrobial therapy in the experimental group compared to standard care

    Time frame: 24 hours after the initiation of empiric antimicrobial therapy

Secondary outcomes

  1. Percentage of patients receiving appropriate anticrobial treatment

    To determine the impact of a PCR-based strategy on the percentage of patients receiving approriate antimicrobial treatment 24 hours after starting empiric antimicrobial therapy in the experimental group compared to standard care

    Time frame: 24 hours after the initiation of empiric antimicrobial therapy

  2. Mechanical ventilation free days

    To determine the impact of a PCR-based strategy on the amount of days alive and free from mechanical ventilation at day 28 after the initiation of empiric antimicrobial therapy in the experimental group compared to standard care

    Time frame: 28 days after the initiation of empiric antimicrobial therapy

  3. ICU Length of stay

    To determine the impact of a PCR-based strategy on the length of stay in the Intensive Care Unit in the experimental group compared to standard care

    Time frame: Until 28 days after the initiation of empiric antimicrobial therapy

  4. 28 days mortality

    To determine the impact of a PCR-based strategy on the mortality at Day 28 after the initiation of empiric antimicrobial therapy in the experimental group compared to standard care

    Time frame: 28 days after the initiation of empiric antimicrobial therapy

  5. Incidence of ICU-acquired infections and colonization involving multidrug resistant bacteria

    To determine the impact of a PCR-based strategy on the incidence of ICU-acquired infections and ICU-acquired colonization involving multidrug resistant bacteria at Day 28 after the initiation of empiric antimicrobial therapy in the experimental group compared to standard care

    Time frame: 28 days after the initiation of empiric antimicrobial therapy

07

Study locations

1 of 1 sites recruiting
  • Houard
    Lille, France
    Recruiting
    • Marion · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2023 (actual). Primary completion is estimated for Mar 2028, 60 months after the start.

Of 81 non-industry interventional studies with no phase under Pneumonia, Ventilator-Associated, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 60 months is above that.

Counting every sponsor, half of 82 studies reached it within 20 months; a quarter within 10 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2022
First posted
Jun 6, 2022
StartActual
Mar 28, 2023
Primary completionEst.
Mar 2028
CompletionEst.
Mar 2028
Last update
Aug 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05405491
Responsible party
Sponsor
First posted
Jun 6, 2022
Start date
Mar 28, 2023
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Aug 7, 2026

Study contacts

Marion HOUARD, MD
Contact
marion.houard@chru-lille.fr
0320445962 ext. +33
Marion HOUARD, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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