MxA and CRP-Guided Use of Antimicrobial Agents for AECOPD

Официальное название

Myxovirus Resistance Protein a and C-Reactive Protein-Guided Antimicrobial Treatment in Outpatients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Обзор

This randomized controlled trial will investigate the clinical impact of Myxovirus Resistance A (MxA) and C-Reactive Protein (CRP)-guided antimicrobial treatment compared to usual care in outpatients with acute exacerbations of chronic obstructive pulmonary disease (AECOPD).

Подробное описание

Respiratory viral infections are a leading cause of acute exacerbations of chronic obstructive pulmonary disease (AECOPD). However, there is currently a lack of rapid diagnostic methods to differentiate the cause of AECOPD, resulting in insufficient attention to viral-induced exacerbations, with antibiotic treatment remaining the primary treatment.

Myxovirus resistance protein A (MxA) has been identified as a potential biomarker to distinguish respiratory viral infections, while C-reactive protein (CRP) has been confirmed as a useful guide for antibiotic therapy in AECOPD.

This randomized controlled trial aims to investigate the clinical value of MxA and CRP-guided antimicrobial treatment in outpatients with AECOPD, with the goal of reducing antibiotic overuse and improving patient outcomes.

Вмешательства

• Другое MxA and CRP tests
  A whole blood sample will be collected on the day of randomization for MxA and CRP testing.
• Другое MxA and CRP feedback
  MxA and CRP results will be reported to the attending physcian within 4 hours, along with antimicrobial treatment guidelines based on these results.
• Другое Follow up
  Telephone visit will be conducted on Day 14, Day 30, and Day 90 after randomization. Day 14 and Day 30 follow-up: antimicrobial usage; additional medical visits, hospitalization, death, symptom scores (CAT score and mMRC score). Day 90 follow-up: Occurrence of another exacerbation of COPD, symptom scores (CAT score and mMRC score), death.

Первичные конечные точки

• 30-day treatment failure rate [Срок оценки: 30 days]

Вторичные конечные точки (9)

• 30-day hospitalization rate [Срок оценки: 30 days]
• 14-day treatment failure rate [Срок оценки: 14 days]
• The rate of antibiotic prescriptions [Срок оценки: 24 hours]
• The rate of antiviral prescriptions [Срок оценки: 24 hours]
• The rate of corticosteroids prescriptions [Срок оценки: 24 hours]
• 30-day antibiotic use rate [Срок оценки: 30 days]
• 30-day antiviral use rate [Срок оценки: 30 days]
• 30-day corticosteroids use rate [Срок оценки: 30 days]
• the rate of next exacerbation [Срок оценки: 90 days]

Критерии участия

Критерии включения

• ≥40 years old；
• Current or former smoker with a minimum smoking history of 10 pack years, clinical diagnosed with mild-to-severe COPD;
• Presenting with an acute exacerbation of COPD
• The severity of AECOPD is mild to moderate.

Критерии исключения

• Required urgent hospitalization
• Received interferon therapy within 30 days before screening
• Had an active systemic inflammatory condition within 30 days prior to screening, such as cerebral infarction, myocardial infarction, or surgery
• Received vaccine in the past 30 days
• Active tuberculosis
• Immunocompromised
• Presenting with current respiratory failure
• Clinical suspicion of pneumonia or pulmonary edema.
• Coexisting bronchiectasis, cystic fibrosis, or asthma
• Had a concurrent infection at another site, such as urinary tract infections or sinusitis;
• Contraindications to antibiotics and/or antivirals
• Known etiology of the present exacerbation
• Pre-treatment with corticosteroids (cumulative dose of methylprednisolone ≥ 80 mg or equivalent dose) for the present exacerbation.

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

Китай · 1 центр

• China-Japan Friendship hospital — Пекин

Идентификаторы

NCT: NCT06779344 · CAP-China AECOPD-bundle

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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