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Investigators propose to conduct a multicenter, prospective, randomized, controlled, assessing the interests of an antibiotic protocol guided by the combined use of serum procalcitonin (PCT) and a broad-panel respiratory multiplex PCR (mPCR) to reduce duration of antibiotics exposure in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) with pneumonia. The primary endpoint is the number of antibiotic-days for the treatment of pneumonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | Conventional microbiological investigations are performed as soon as possible after ICU admission including blood cultures, non-invasive or invasive respiratory tract sample, urine antigen assays and viral PCR. Antibiotics have to be started as soon as possible after ICU admission and during at less 3 days | |
| Intervention | Experimental | In addition to conventional microbiological investigations, a non-invasive or invasive respiratory tract sample is collected as soon as possible and tested with the respiratory broad-panel mPCR (Biofire FilmArray Pneumonia plus Panel de Biomérieux). This test detects 18 bacteria, 9 viruses and 7 antibiotic resistance markers. In addition a procalcitonin assay is performed on day-3 of ICU admission. Antibiotics have to be started as soon as possible after ICU admission and during at less 3 days. At day 3, clinicians have to consider all the early microbiological results (including the respiratory broad-panel mPCR (Biofire FilmArray Pneumonia plus Panel de Biomérieux) and procalcitonin, and subsequently to apply an algorithm of early antibiotics discontinuation or de-escalation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| experimental | Other | At day 3, clinicians have to consider all the early microbiological results (including the respiratory broad-panel mPCR (Biofire FilmArray Pneumonia plus Panel de Biomérieux) and procalcitonin, and subsequently to apply an algorithm of early antibiotics discontinuation or de-escalation. Discontinuation is encouraged in case of no bacteria documentation and a procalcitonin < 1 ng/L; discontinuation is even encouraged if a viral documentation is concurrently obtained. In case of no bacteria documentation and a procalcitonin > 1 nd/L, antibiotic continuation is encouraged for additional two days. In case of bacteria documentation, antibiotic continuation is encouraged, but with narrowing the spectrum as much as possible. The duration of antibiotics is based on a procalcitonin algorithm: procalcitonin < 0.1 nd/l: discontinuation; 0.1 ng/l < procalcitonin < 0.25 ng/l: additional 1 day; procalcitonin > 0.25 ng/l: additional 2 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of antibiotic therapy | The number of antibiotic-days for the treatment of pneumonia | from ICU admission to day 28 or hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| cedric daubin, MD | Contact | 33 2 31 06 47 16 | daubin-c@chu-caen.fr |
| Name | Affiliation | Role |
|---|---|---|
| cedric daubin, MD | CHU de Caen Normandie, Médecine Intensive et Réanimation Médicale, 14000 CAEN, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Intensive Care Unit, CHU Caen | Recruiting | Caen | 14000 | France |
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