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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000735-41 | EudraCT Number |
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lack of inclusion pandemic, investigator reluctance, lower than expected incidence of infection
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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).
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:
Antibiotic treatment is standardized, based on the time of onset of VAT, and presence of risk factors for MDR bacteria:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no antibiotic treatment for VAT | Placebo Comparator | 3 days of 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:
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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ceftriaxone | Drug | 2 g iv every 24h |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients with a transition from VAT to VAP, | VAP is defined using the following criteria:
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. | from randomization to day 28 (4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| duration of mechanical ventilation-free days | from randomization to day 28 (4 weeks) | |
| duration of antibiotic free-days | from randomization to day 28 (4 weeks) | |
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Inclusion Criteria:
VAT is defined using the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saad NSEIR, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Roger Salengro, CHRU | Lille | France |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002443 | Ceftriaxone |
| D002939 | Ciprofloxacin |
| D015378 | Imipenem |
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
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| ciprofloxacin |
| Drug |
400 mg iv every 8h |
|
| imipenem | Drug | 1 g iv every 8h |
|
| linezolid | Drug | 600 mg iv every 12h |
|
| placebo | Drug | 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 |
|
| length of ICU stay |
| from randomization to day 28 (4 weeks) |
| mortality | at day 28 and day 90 after randomization |
| percentage of patients with ICU-acquired colonization related to MDR bacteria | from randomization to day 28 (4 weeks) |
| percentage of patients with ventilator-associated events | from randomization to day 28 (4 weeks) |
| percentage of patients with ICU-acquired infection related to MDR bacteria | from randomization to day 28 (4 weeks) |
| D007769 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D000081 | Acetamides |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |