Status:

NOT_YET_RECRUITING

Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients

Lead Sponsor:

Ningbo No. 1 Hospital

Conditions:

Chronic Obstructive Pulmonary Disease, COPD

Eligibility:

All Genders

40-80 years

Phase:

NA

Brief 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 the...

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 prescript...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 20 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 31 2026

Estimated Enrollment :

440 Patients enrolled

Trial Details

Trial ID

NCT06612476

Start Date

September 20 2024

End Date

August 31 2026

Last Update

September 25 2024

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