Prospective Randomized Clinical Trial Assessing the Value of an Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Medical Intensive Care Unit, CHU Caen
RECRUITING
Caen
Contact Information
Primary
cedric daubin, MD
daubin-c@chu-caen.fr
33 2 31 06 47 16
Time Frame
Start Date: 2024-05-07
Estimated Completion Date: 2026-07-15
Participants
Target number of participants: 64
Treatments
No_intervention: control
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
Experimental: Intervention
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.
Sponsors
Leads: University Hospital, Caen

This content was sourced from clinicaltrials.gov