An Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care

Not Applicable

Recruiting

• Conditions: To Reduce Duration of Antibiotics Exposure in Patients With COPD Hospitalized in Intensive Care Unit With Pneumonia

• Registration Number: NCT06301841
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-08
• Study Start: 2024-05-07
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-24
• Primary Completion: 2026-04-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Duration of antibiotic therapy	from ICU admission to day 28 or hospital discharge	The number of antibiotic-days for the treatment of pneumonia

Trial Locations

Locations (1)

Medical Intensive Care Unit, CHU Caen; 🇫🇷 Caen, France