Mechanical Ventilation ComplicationPhase 4TAVeM2NCT03012360
Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis
A Phase 4 study testing ceftriaxone, ciprofloxacin and imipenem in people with Mechanical Ventilation Complication and Critical Illness, run by University Hospital, Lille at 1 site in France.
Trial summary
Antimicrobial treatment could be beneficial in patients with ventilator-associated tracheobronchitis (VAT). The hypothesis of this study is that antibiotic treatment for VAT (3 or 7 days), compared with no antibiotic treatment, would reduce the incidence of transition from VAT to ventilator-associated pneumonia (VAP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Critical Illness
- What is being tested?
- ceftriaxone, ciprofloxacin and imipenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2018to 7 Jul 2024
- Phase
- Phase 4
- 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
- All adult patients hospitalized in the ICU with a first episode of VAT diagnosed >48 hours after starting invasive mechanical ventilation are eligible for this study.
- VAT is defined using the following criteria:
- absence of new infiltrate on chest X ray
- two of the three following conditions: fever > 38.5 °C or <36.5, leucocyte count > than 12 000 cells per μL or <than 4000 cells per μL purulent tracheal secretions
- and positive tracheal aspirate (≥105 cfu/mL)
Who cannot join
- long-term tracheostomy at ICU admission
- patients who develop VAP before VAT
- patients already receiving antibiotics active against all the microorganisms responsible for VAT
- severe immunosuppression
- pregnancy or breastfeeding
- patients <18 years
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- patients already included in another study, with potential interaction with the primary objective of the current study
- known resistance to imipenem and ciprofloxacin of bacteria responsible for VAT
- treatment limitation decisions
- moribund patients (likely to die within 24 h)
- allergy to any of study drugs: hypersensitivity to any carbapenem, severe hypersensitivity (for example anaphylactic reaction or severe cutaneous reaction) to any other antibiotic form beta-lactam group (such as penicillin or cephalosporin), severe hypersensitivity (for example anaphylactic reaction) to any other antibiotic from beta-lactam group (penicillin, monobactam or carbapenem), hypersensitivity to quinolones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis: a Prospective Randomized Placebo-controlled Double-blind Multicenter Trial
Antimicrobial treatment could be beneficial in patients with ventilator-associated tracheobronchitis (VAT). The hypothesis of this study is that antibiotic treatment for VAT (3 or 7 days), compared with no antibiotic treatment, would reduce the incidence of transition from VAT to ventilator-associated pneumonia (VAP).
Read the detailed description
The main objective of this randomized controlled multicenter double-blind trial is to assess the efficiency of two durations (3 or 7 days) of antibiotic treatment for VAT, compared with no antibiotic treatment, in reducing the incidence of transition from VAT to ventilator-associated pneumonia (VAP).
Secondary objectives are to determine the impact of two durations (3 or 7 days) of antibiotic treatment for VAT, compared with no antibiotic treatment, on:
- duration of mechanical-ventilation free days
- duration of antibiotic free days
- length of ICU stay
- mortality at day 28 and day 90
- incidence of ICU-acquired colonization related to multidrug resistant (MDR) bacteria
- incidence of ICU-acquired infection related to MDR bacteria
- incidence of ventilator-associated events After informed consent, patients will be randomized (1:1:1) to receive 0 (control group), 3 or 7 days (experimental groups) of antibiotic treatment for VAT
Antibiotic treatment is standardized, based on the time of onset of VAT, and presence of risk factors for MDR bacteria:
- patients with early-onset VAT with no risk factor for MDR bacteria will receive ceftriaxone (2 g iv every 24h).
- patients with late-onset VAT (after day 4 of mechanical ventilation), or with at least one risk factor for MDR bacteria will receive imipenem (1 g iv every 8h), and ciprofloxacin (400 mg iv every 8h) as empirical treatment. When methicillin-resistant Staphylococcus aureus is suspected, linezolid (600 mg iv every 12h) will be added to empirical treatment.
Patients randomized in control group will receive 7 days of placebo, and those randomized in the first experimental arm (3 days of antibiotics) will receive 4 days of placebo.
- Being tested
- ceftriaxone, ciprofloxacin, imipenem, linezolid, placebo
- Keywords
- Infectiology, Biology of infectious agents, Hygiene, Pneumology, Critical Care
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftriaxoneDrug
2 g iv every 24h
ciprofloxacinDrug
400 mg iv every 8h
imipenemDrug
1 g iv every 8h
linezolidDrug
600 mg iv every 12h
placeboDrug
The SSI 0.9% or dextrose 5% used are based on routine procedure in different participating centers.Placebo will be prepared using IV bags, with the same of quantity as IMP
| Study group | Role | What they receive |
|---|---|---|
| no antibiotic treatment for VAT | Placebo comparator | 3 days of placebo Receives: Drug: placebo |
| antibiotic treatment for 3 days | Experimental | Patients randomized in one of the two experimental groups will receive 3 days of antimicrobials. Antibiotic treatment is standardized, based on the time of onset of VAT, and presence of risk factors for MDR bacteria:
* patients with early-onset VAT (< 5 days of mechanical ventilation), with no risk factor for MDR will receive ceftriaxone .
* patients with late-onset VAT (≥5 days of mechanical ventilation), or with at least one risk factor for multidrug resistant bacteria will receive imipenem , and ciprofloxacin as empirical treatment.
When methicillin-resistant Staphylococcus aureus (MRSA) is suspected linezolid will be added to empirical treatment.
3 days of imipenem and ciprofloxacin with optional linezolid, followed by 4 d of placebo Receives: Drug: ceftriaxone; Drug: ciprofloxacin; Drug: imipenem; Drug: linezolid; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with a transition from VAT to VAP,
VAP is defined using the following criteria:
- new or progressive pulmonary infiltrate
- two of the following criteria: temperature >38°C or <36.5°C leukocyte count >12,000/μL or <4,000/μL purulent endotracheal aspirate
- positive tracheal aspirate (≥105 cfu/mL) or bronchoalveolar lavage (≥104 cfu/mL).
VAP will be considered as subsequent to VAT, when it is diagnosed >24h after VAT occurrence. Only first episodes of VAP diagnosed >48h after starting mechanical ventilation will be taken into account.
Measured: from randomization to day 28 (4 weeks)
Secondary outcomes (7)
duration of mechanical ventilation-free days
Measured: from randomization to day 28 (4 weeks)
duration of antibiotic free-days
Measured: from randomization to day 28 (4 weeks)
length of ICU stay
Measured: from randomization to day 28 (4 weeks)
mortality
Measured: at day 28 and day 90 after randomization
percentage of patients with ICU-acquired colonization related to MDR bacteria
Measured: from randomization to day 28 (4 weeks)
percentage of patients with ventilator-associated events
Measured: from randomization to day 28 (4 weeks)
percentage of patients with ICU-acquired infection related to MDR bacteria
Measured: from randomization to day 28 (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start8 Feb 2018
- Primary completion7 Jul 2024
- Study completion7 Jul 2024
Why it stopped: lack of inclusion pandemic, investigator reluctance, lower than expected incidence of infection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Saad NSEIR, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012360
- Sponsor's protocol ID
- 2015_66
- Other IDs
- 2016-000735-41, 2016
- Acronym
- TAVeM2
- Status last verified
- Dec 2025
- First submitted
- 13 Dec 2016
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis: a Prospective Randomized Placebo-controlled Double-blind Multicenter Trial
- ClinicalTrials.gov ID
- NCT03012360
- Acronym / sponsor ID
- TAVeM2 / 2015_66
- Keywords
- Infectiology, Biology of infectious agents, Hygiene, Pneumology, Critical Care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusion pandemic, investigator reluctance, lower than expected incidence of infection
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 7 Jul 2024 (actual)
- Study completion
- 7 Jul 2024 (actual)
- First posted
- 6 Jan 2017 (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.
Antimicrobial treatment could be beneficial in patients with ventilator-associated tracheobronchitis (VAT). The hypothesis of this study is that antibiotic treatment for VAT (3 or 7 days), compared with no antibiotic treatment, would reduce the incidence of transition from VAT to ventilator-associated pneumonia (VAP).
Detailed description
The main objective of this randomized controlled multicenter double-blind trial is to assess the efficiency of two durations (3 or 7 days) of antibiotic treatment for VAT, compared with no antibiotic treatment, in reducing the incidence of transition from VAT to ventilator-associated pneumonia (VAP).
Secondary objectives are to determine the impact of two durations (3 or 7 days) of antibiotic treatment for VAT, compared with no antibiotic treatment, on:
- duration of mechanical-ventilation free days
- duration of antibiotic free days
- length of ICU stay
- mortality at day 28 and day 90
- incidence of ICU-acquired colonization related to multidrug resistant (MDR) bacteria
- incidence of ICU-acquired infection related to MDR bacteria
- incidence of ventilator-associated events After informed consent, patients will be randomized (1:1:1) to receive 0 (control group), 3 or 7 days (experimental groups) of antibiotic treatment for VAT
Antibiotic treatment is standardized, based on the time of onset of VAT, and presence of risk factors for MDR bacteria:
- patients with early-onset VAT with no risk factor for MDR bacteria will receive ceftriaxone (2 g iv every 24h).
- patients with late-onset VAT (after day 4 of mechanical ventilation), or with at least one risk factor for MDR bacteria will receive imipenem (1 g iv every 8h), and ciprofloxacin (400 mg iv every 8h) as empirical treatment. When methicillin-resistant Staphylococcus aureus is suspected, linezolid (600 mg iv every 12h) will be added to empirical treatment.
Patients randomized in control group will receive 7 days of placebo, and those randomized in the first experimental arm (3 days of antibiotics) will receive 4 days of placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no antibiotic treatment for VAT | Placebo comparator | Drug: placebo3 days of placebo |
| antibiotic treatment for 3 days | Experimental | Drug: ceftriaxone, Drug: ciprofloxacin, Drug: imipenem, Drug: linezolid, Drug: placeboPatients randomized in one of the two experimental groups will receive 3 days of antimicrobials. Antibiotic treatment is standardized, based on the time of onset of VAT, and presence of risk factors for MDR bacteria: * patients with early-onset VAT (< 5 days of mechanical ventilation), with no risk factor for MDR will receive ceftriaxone . * patients with late-onset VAT (≥5 days of mechanical ventilation), or with at least one risk factor for multidrug resistant bacteria will receive imipenem , and ciprofloxacin as empirical treatment. When methicillin-resistant Staphylococcus aureus (MRSA) is suspected linezolid will be added to empirical treatment. 3 days of imipenem and ciprofloxacin with optional linezolid, followed by 4 d of placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All adult patients hospitalized in the ICU with a first episode of VAT diagnosed >48 hours after starting invasive mechanical ventilation are eligible for this study.
- absence of new infiltrate on chest X ray
- two of the three following conditions: fever > 38.5 °C or <36.5, leucocyte count > than 12 000 cells per μL or <than 4000 cells per μL purulent tracheal secretions
- and positive tracheal aspirate (≥105 cfu/mL)
Key exclusion criteria (11 listed)
- long-term tracheostomy at ICU admission
- patients who develop VAP before VAT
- patients already receiving antibiotics active against all the microorganisms responsible for VAT
- severe immunosuppression
- pregnancy or breastfeeding
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 |
|---|---|---|
| ceftriaxone2 g iv every 24h | Drug | antibiotic treatment for 3 days |
| ciprofloxacin400 mg iv every 8h | Drug | antibiotic treatment for 3 days |
| imipenem1 g iv every 8h | Drug | antibiotic treatment for 3 days |
| linezolid600 mg iv every 12h | Drug | antibiotic treatment for 3 days |
| placeboThe SSI 0.9% or dextrose 5% used are based on routine procedure in different participating centers.Placebo will be prepared using IV bags, with the same of quantity as IMP | Drug | antibiotic treatment for 3 days, no antibiotic treatment for VAT |
Primary outcome
The percentage of patients with a transition from VAT to VAP,
Time frame: from randomization to day 28 (4 weeks)
VAP is defined using the following criteria: 1. new or progressive pulmonary infiltrate 2. two of the following criteria: temperature >38°C or <36.5°C leukocyte count >12,000/μL or <4,000/μL purulent endotracheal aspirate 3. positive tracheal aspirate (≥105 cfu/mL) or bronchoalveolar lavage (≥104 cfu/mL). VAP will be considered as subsequent to VAT, when it is diagnosed >24h after VAT occurrence. Only first episodes of VAP diagnosed >48h after starting mechanical ventilation will be taken into account.
7 secondary outcomes
duration of mechanical ventilation-free days
Time frame: from randomization to day 28 (4 weeks)
duration of antibiotic free-days
Time frame: from randomization to day 28 (4 weeks)
length of ICU stay
Time frame: from randomization to day 28 (4 weeks)
mortality
Time frame: at day 28 and day 90 after randomization
percentage of patients with ICU-acquired colonization related to MDR bacteria
Time frame: from randomization to day 28 (4 weeks)
percentage of patients with ventilator-associated events
Time frame: from randomization to day 28 (4 weeks)
percentage of patients with ICU-acquired infection related to MDR bacteria
Time frame: from randomization to day 28 (4 weeks)
Results and safety
The study was stopped early (reason given: lack of inclusion pandemic, investigator reluctance, lower than expected incidence of infection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Saad NSEIR, MD, PhD 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 Phase 4 study testing ceftriaxone, ciprofloxacin and imipenem in people with Mechanical Ventilation Complication and Critical Illness, 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 11 Dec 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: lack of inclusion pandemic, investigator reluctance, lower than expected incidence of infection). Results are not available in the source record.
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?
The percentage of patients with a transition from VAT to VAP, (time frame: from randomization to day 28 (4 weeks)). 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 11 Dec 2025.