Search / Trial NCT06612476

Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients

Launched by NINGBO NO. 1 HOSPITAL · Sep 21, 2024

Trial Information

Current as of October 07, 2024

Not yet recruiting

Keywords

Aecopd Interleukin 6 Antibiotic Therapy

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 whe...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. AECOPD patients admitted to hospitals
  • 2. The exacerbation has lasted for at least 24 hours but equal to or less than 21 days
  • 3. ≥40 years of age but no more than 80 years old
  • 4. With at least 10 pack-year history of smoking
  • 5. Able to provide written informed consent and ensure the completion of the trial
  • Exclusion Criteria:
  • 1. Axillary temperature≥38°C
  • 2. Acute pneumonia identified by X-Ray or CT of the chest
  • 3. Severe respiratory failure requiring admittance to ICU
  • 4. Comorbidities require antibiotic therapy (i.e. infection at another site, systematic infection, active chronic inflammatory condition, specific viral infection)
  • 5. Immunosuppression status (i.e., patients with HIV infection, with malignant tumor of blood system, receiving chemotherapy)
  • 6. Concurrent diseases requiring corticosteroids (equivalent to 60mg prednisone/day or more than 30 days)
  • 7. Antibiotic use in the previous four weeks
  • 8. Current tracheotomy status
  • 9. Bronchiectasis of origin other than COPD
  • 10. Invasive mechanical ventilation
  • 11. Patients diagnosed malignant tumors
  • 12. Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception.
  • 13. Newly diagnosed pulmonary embolism
  • 14. Participation in another clinical trial

About Ningbo No. 1 Hospital

Ningbo No. 1 Hospital is a leading medical institution located in Ningbo, China, dedicated to advancing healthcare through innovative clinical research and trials. With a strong emphasis on patient-centered care, the hospital is equipped with state-of-the-art facilities and a multidisciplinary team of experienced professionals. As a clinical trial sponsor, Ningbo No. 1 Hospital aims to contribute to the development of new therapies and treatment protocols, ensuring the highest standards of safety and efficacy while fostering collaboration with national and international research organizations. Their commitment to excellence in clinical research underpins their mission to enhance patient outcomes and promote medical advancements.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0