Pneumonia, Ventilator-AssociatedRESPIRENCT05405491
Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Immunocompromised Patients With Hospital-acquired Pneumonia Requiring Mechanical Ventilation
A study testing PCR based strategy in people with Pneumonia, Ventilator-Associated and Pneumonia, Hospital-Acquired, run by University Hospital, Lille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated, Pneumonia, Hospital-Acquired, Immunodeficiency
- What is being tested?
- PCR based strategy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2023to Mar 2028
- 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 immunocompromised patients hospitalized in ICU with suspected VAP or HAP requiring MV
Who cannot join
- No immunodeficiency Moribund patients (SAPS II > 90) Pregnant women Refuse to participate to the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of a Strategy Based on the PCR Testing System on Appropriate and Targeted Antimicrobial Treatment in Immunocompromised Patients With Suspected Ventilator-associated Pneumonia or Hospital-acquired Pneumonia Requiring Mechanical Ventilation : a Randomized Controlled Unblinded Trial
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
- Being tested
- PCR based strategy, Standard care
- Keywords
- Ventilator-associated pneumonia, Hospital-acquired pneumonia, Immunodeficiency, Antimicrobial therapy, Polymerase chain reaction (PCR)
- Medical subject headings
- Pneumonia, Ventilator-Associated, Healthcare-Associated Pneumonia, Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR based strategyOther
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
Standard careOther
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
| Study group | Role | What they receive |
|---|---|---|
| PCR group | Experimental | Not described Receives: Other: PCR based strategy |
| Control group | Sham comparator | Not described Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours after the initiation of empiric antimicrobial therapy
Secondary outcomes (5)
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
Measured: 24 hours after the initiation of empiric antimicrobial therapy
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
Measured: 28 days after the initiation of empiric antimicrobial therapy
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
Measured: Until 28 days after the initiation of empiric antimicrobial therapy
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
Measured: 28 days after the initiation of empiric antimicrobial therapy
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
Measured: 28 days after the initiation of empiric antimicrobial therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start28 Mar 2023
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion HOUARD, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405491
- Sponsor's protocol ID
- 2021_0344
- Other IDs
- 2021-A02900-41
- Acronym
- RESPIRE
- Status last verified
- Dec 2025
- First submitted
- 31 May 2022
- Last updated
- 7 Aug 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Strategy Based on the PCR Testing System on Appropriate and Targeted Antimicrobial Treatment in Immunocompromised Patients With Suspected Ventilator-associated Pneumonia or Hospital-acquired Pneumonia Requiring Mechanical Ventilation : a Randomized Controlled Unblinded Trial
- ClinicalTrials.gov ID
- NCT05405491
- Acronym / sponsor ID
- RESPIRE / 2021_0344
- Keywords
- Ventilator-associated pneumonia, Hospital-acquired pneumonia, Immunodeficiency, Antimicrobial therapy, Polymerase chain reaction (PCR)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 6 Jun 2022 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCR group | Experimental | Other: PCR based strategy |
| Control group | Sham comparator | Other: Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult immunocompromised patients hospitalized in ICU with suspected VAP or HAP requiring MV
Key exclusion criteria (1 listed)
- No immunodeficiency Moribund patients (SAPS II > 90) Pregnant women Refuse to participate to the study
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 |
|---|---|---|
| PCR based strategyEarly 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 | Other | PCR group |
| Standard careBroad-spectrum antimicrobial therapy adjustment after results of standard microbiological culture of the tracheal aspirate in immunocompromised patients with suspected VAP or HAP requiring MV | Other | Control group |
Primary outcome
Increase in percentage of patients with targeted antibiotics
Time frame: 24 hours after the initiation of empiric antimicrobial therapy
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
5 secondary outcomes
Percentage of patients receiving appropriate anticrobial treatment
Time frame: 24 hours after the initiation of empiric antimicrobial therapy
Mechanical ventilation free days
Time frame: 28 days after the initiation of empiric antimicrobial therapy
ICU Length of stay
Time frame: Until 28 days after the initiation of empiric antimicrobial therapy
28 days mortality
Time frame: 28 days after the initiation of empiric antimicrobial therapy
Incidence of ICU-acquired infections and colonization involving multidrug resistant bacteria
Time frame: 28 days after the initiation of empiric antimicrobial therapy
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 7 Aug 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.
Marion HOUARD, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCR based strategy in people with Pneumonia, Ventilator-Associated and Pneumonia, Hospital-Acquired, run by University Hospital, Lille at 1 site 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 1 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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Marion HOUARD, MD (0320445962 ext. +33, marion.houard@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in percentage of patients with targeted antibiotics (time frame: 24 hours after the initiation of empiric antimicrobial therapy). 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 7 Aug 2026.