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NCT Number: NCT06301841

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Intensive Care Unit, CHU Caen

Caen, 14000, France

Location status: Recruiting

Location contact

Cédric Daubin, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental

Other

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.

Primary outcomes

  1. Duration of antibiotic therapy

    Time frame: from ICU admission to day 28 or hospital discharge

    The number of antibiotic-days for the treatment of pneumonia

Study contacts

Contact information is provided by the study sponsor or research team.

cedric daubin, MD

CONTACT

[email protected]

33 2 31 06 47 16

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: BPCTréa2

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 8, 2024
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.