NCT06301841

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	experimental	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.

Timeline

• Start date: 2024-05-07
• Primary completion: 2026-04-15
• Completion: 2026-07-15
• First posted: 2024-03-08
• Last updated: 2025-07-24

Locations

1 site across 1 country: France