Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Incidence of antibiotic use [Time frame: During the 30-day period after randomization]
• Proportion of successful treatments [Time frame: During the 30-day period after randomization]

Secondary outcome measures (12)

• Incidence of antibiotic use [Time frame: During the first day period after randomization]
• Antibiotic utilization in the hospital [Time frame: Between randomization and discharge, limited to 30 days]
• Duration of hospitalization [Time frame: Between randomization and discharge, limited to 30 days]
• Frequency of subsequent exacerbations [Time frame: During the 30-day period after randomization]
• Incidence of hospital readmission [Time frame: Between the discharge date and 30 days post-randomization]
• All-cause mortality [Time frame: During the 30-day period after randomization]
• Frequency of ICU admissions [Time frame: During the 30-day period after randomization]
• noninvasive mechanical ventilation [Time frame: During the 30-day period after randomization]
• Change in COPD assessment test [Time frame: From the initial hospital admission baseline to 30 days after randomization]
• Change in St. George's Respiratory Questionnaire [Time frame: From the initial hospital admission baseline to 30 days after randomization]
• Change in modified Medical Research Council (mMRC) score [Time frame: From the initial hospital admission baseline to 30 days after randomization]
• Change in Hospital Anxiety and Depression Scale [Time frame: From the initial hospital admission baseline to 30 days after randomization]

Eligibility criteria

Inclusion criteria

• AECOPD patients admitted to hospitals
• The exacerbation has lasted for at least 24 hours but equal to or less than 21 days
• ≥40 years of age but no more than 80 years old
• With at least 10 pack-year history of smoking
• Able to provide written informed consent and ensure the completion of the trial

Exclusion criteria

• Axillary temperature≥38°C
• Acute pneumonia identified by X-Ray or CT of the chest
• Severe respiratory failure requiring admittance to ICU
• Comorbidities require antibiotic therapy (i.e. infection at another site, systematic infection, active chronic inflammatory condition, specific viral infection)
• Immunosuppression status (i.e., patients with HIV infection, with malignant tumor of blood system, receiving chemotherapy)
• Concurrent diseases requiring corticosteroids (equivalent to 60mg prednisone/day or more than 30 days)
• Antibiotic use in the previous four weeks
• Current tracheotomy status
• Bronchiectasis of origin other than COPD
• Invasive mechanical ventilation
• Patients diagnosed malignant tumors
• Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception.
• Newly diagnosed pulmonary embolism
• Participation in another clinical trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06612476 · 2024-R046-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗