MxA and CRP-Guided Use of Antimicrobial Agents for AECOPD

NCT06779344 | Not Yet Recruiting

• 1 other identifier: CAP-China AECOPD-bundle
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Exacerbation Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 30-day treatment failure rate

  Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 30.

  30 days

Secondary Outcomes (9)

• 30-day hospitalization rate

  30 days

• 14-day treatment failure rate

  14 days

• The rate of antibiotic prescriptions

  24 hours

• The rate of antiviral prescriptions

  24 hours

• The rate of corticosteroids prescriptions

  24 hours

Other Outcomes (2)

• The CAT symptom score

  14 days, 30 days, 90 days

• mMRC symptom score

  14 days, 30 days, 90 days

Study Arms (2)

MxA and CRP-guided group

EXPERIMENTAL

Perform MxA and CRP test; Report MxA and CRP results to attending clinicians; Provide MxA and CRP-based guidelines for antimicrobial treatment to the attending clinicians; Conduct follow-up telephone visits on Day 14, Day 30, and Day 90

Other: MxA and CRP tests; Other: MxA and CRP feedback; Other: Follow up

Usual-care group

ACTIVE COMPARATOR

Conduct follow-up telephone visits on Day 14, Day 30, and Day 90.

Other: Follow up

Interventions

MxA and CRP tests OTHER

A whole blood sample will be collected on the day of randomization for MxA and CRP testing.

MxA and CRP-guided group

MxA and CRP feedback OTHER

MxA and CRP results will be reported to the attending physcian within 4 hours, along with antimicrobial treatment guidelines based on these results.

MxA and CRP-guided group

Follow up OTHER

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.

MxA and CRP-guided group; Usual-care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

China-Japan Friendship hospital

Beijing, Beijing Municipality, 100029, China

Location

Study Officials

• Bin Cao

  China-Japan Friendship Hospital

  STUDY DIRECTOR

Central Study Contacts

Yeming Wang, M.D.

CONTACT

+86 84206264; wwyymm_love@163.com

Mengwei Yan, M.D.

CONTACT

yanmengwei_happy@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 16, 2025
• Study Start: January 13, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CN (1)