Using procalcitonin and rapid respiratory PCR to shorten antibiotics for ICU COPD patients with pneumonia
Official title: Prospective Randomized Clinical Trial Assessing the Value of an Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care
Run by University Hospital, Caen · NCT06301841 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 64 (estimated) |
| Sponsor | University Hospital, Caen Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Caen) |
| Status | Recruiting |
| Started | May 7, 2024 |
| Main results expected | April 15, 2026 |
| Study ends | July 15, 2026 |
| Registry record updated | July 24, 2025 |
| Trial ID | NCT06301841 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
- Email: daubin-c@chu-caen.fr
- Phone: 33 2 31 06 47 16
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.