NCT06612476

Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients

Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients: a Multicenter Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Ningbo No. 1 Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this multicenter, prospective, randomized controlled study, we aimed to figure out, compared with the global chronic obstructive pulmonary disease initiative (GOLD) guideline -guided antibiotic therapy, whether Interleukin 6 (IL6)-guided antibiotic therapy for acute exacerbation of chronic obstructive pulmonary disease (AECOPD) can lead to a reduction in the use of antibiotics without increasing the rate of treatment failure.

Detailed description

Acute exacerbation is the first leading cause of hospitalization and mortality among patients with COPD. Infection of bacteria has been detected in 49.59% of patients with AECOPD. Antibiotic prescriptions for AECOPD patients are usually based on GOLD guideline. However, the newest study reported that more than 85% of AECOPD inpatients received antibiotic prescription in the United States, Europe and China. Not all patients will equally experience benefit from antibiotics. Interleukin 6 (IL6) was determined as a reliable clinical biomarker in guiding antimicrobial use. It remains unclear whether IL6-guided antibiotic therapy is safe and effective for hospitalized patients with AECOPD. The study will recruit 440 AECOPD inpatients from at least six hospitals based in China. Eligible participants will be assigned to receive either IL6-guided antibiotic therapy or GOLD-guided antibiotic therapy in 1:1 ratio randomly. The hypothesis for this study is that IL-6 guided antibiotic therapy will reduce the rate of antibiotic prescriptions for AECOPD without increasing the rate of treatment failure, compared with the group treated with GOLD-guided antibiotic therapy.

Conditions

• Chronic Obstructive Pulmonary Disease, COPD

Interventions

Type	Name	Description
DRUG	Interleukin 6-guided antibiotic therapy	In Interleukin-6 group, antibiotic prescription decisions will made according to the results of IL-6.
DRUG	GOLD-guided antibiotic therapy	In guideline group, antibiotic prescription decisions will made according to the recommendations of GOLD guideline.

Timeline

• Start date: 2024-09-20
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2024-09-25
• Last updated: 2024-09-25