An Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: experimental.
- Who it may be relevant to
- Registry conditions: To Reduce Duration of Antibiotics Exposure in Patients With COPD Hospitalized in Intensive Care Unit With Pneumonia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Randomized Clinical Trial Assessing the Value of an Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care
Overview
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.
Interventions
- Other experimental
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 docu
Primary outcome measures
- Duration of antibiotic therapy [Time frame: from ICU admission to day 28 or hospital discharge]
Eligibility criteria
Inclusion criteria
- Patients over 18 years
- Documented or suspected clinically COPD according to the criteria of GOLD
- Community-acquired pneumonia defined as the presence of a radiological (i.e., chest X-ray or CTscan) infiltrates consistent with an infectious site and associated with one or more of the following items: dyspnea, cough, sputum, fever above 38 ° C, chest pain, localized crackles with or without signs of pleural effusion, higher leukocytosis at 10,000 / mm³ or leukopenia below 4000 / mm³
- Admitted to the hospital for less than 48 hours
- ICU Admission
- Informed Consent signed by the patient or his representative
Exclusion criteria
- Patient immunocompromised including congenital immunodeficiency, haematologic malignancy, immunosuppressive drugs (including anticancer chemotherapy and post-transplantation therapies), neutropenia neutrophil count below 500 / mm³ secondary to chemotherapy, corticosteroids greater than 0.5 mg / kg / day for more than 10 days, HIV infection
- Therapeutic limitation Existence
- Minor patient or under guardianship or custody
- Pregnant woman
- Refusal to participate in the study
- The inclusion of the subject in another biomedical research protocol in progress or for less than 30 day
- Patients treated with antibiotics before ICU referral are no excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Medical Intensive Care Unit, CHU Caen — Caen
Identifiers
NCT: NCT06301841 · 2023-A00903-42