ClinicalTrialsFinder
RecruitingNot ApplicableNCT06301841

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

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

Sponsor

University Hospital, Caen

Enrollment

64 participants

Start Date

May 7, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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.

Interventions

OTHERexperimental

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.

Locations(1)

Medical Intensive Care Unit, CHU Caen

Caen, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06301841