Using procalcitonin and rapid respiratory PCR to shorten antibiotics for ICU COPD patients with pneumonia

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

This will test whether using blood procalcitonin levels together with a broad-panel respiratory PCR can shorten antibiotic treatment for adults with COPD admitted to the ICU for pneumonia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Caen (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Caen)
• Trial ID: NCT06301841 on ClinicalTrials.gov

What this trial studies

This is a multicenter, prospective, randomized, controlled protocol that guides antibiotic duration using a combined strategy of serum procalcitonin (PCT) monitoring and a broad-panel respiratory multiplex PCR (mPCR). Adults with documented or suspected COPD admitted to the ICU for community-acquired pneumonia are randomized to the PCT+mPCR-guided protocol or standard care. The primary endpoint is the total number of antibiotic-days prescribed for the pneumonia episode. Immunocompromised patients are excluded and enrollment occurs at the participating intensive care units.

Who should consider this trial

Good fit: Adults (≥18) with documented or suspected COPD per GOLD criteria admitted to the ICU within 48 hours for community-acquired pneumonia who can provide informed consent or have an authorized representative.

Not a fit: Immunocompromised patients (for example those on chemotherapy, high-dose steroids, with severe neutropenia, or advanced HIV) and patients not treated at the enrolling ICU are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the protocol could safely reduce total antibiotic days, lowering drug side effects and the risk of antibiotic resistance.

How similar studies have performed: Randomized trials of procalcitonin-guided algorithms have reduced antibiotic duration in respiratory and ICU settings, while broad-panel respiratory multiplex PCR is promising for faster pathogen identification and their combined use is relatively novel.

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.

Where this trial is running

Caen

• Medical Intensive Care Unit, CHU Caen — Caen, France (Recruiting)

Study contacts

• Principal investigator: cedric daubin, MD — CHU de Caen Normandie, Médecine Intensive et Réanimation Médicale, 14000 CAEN, France
• Study coordinator: cedric daubin, MD

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