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

University Hospital, Caen1 site in 1 country64 target enrollmentMay 7, 2024

ConditionsTo Reduce Duration of Antibiotics Exposure in Patients With COPD Hospitalized in Intensive Care Unit With Pneumonia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: To Reduce Duration of Antibiotics Exposure in Patients With COPD Hospitalized in Intensive Care Unit With Pneumonia
Sponsor: University Hospital, Caen
Enrollment: 64
Locations: 1
Primary Endpoint: Duration of antibiotic therapy
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 7, 2024

End Date

July 15, 2026

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Caen

Responsible Party

Sponsor

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.