Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Interleukin 6-guided antibiotic therapy
  In Interleukin-6 group, antibiotic prescription decisions will made according to the results of IL-6.
• Препарат GOLD-guided antibiotic therapy
  In guideline group, antibiotic prescription decisions will made according to the recommendations of GOLD guideline.

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06612476 · 2024-R046-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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