Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients

NCT ID: NCT06612476

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2026-08-31

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 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.

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 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.

Conditions

Chronic Obstructive Pulmonary Disease, COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interleukin 6-guided antibiotic therapy (Interleukin-6 group)

After randomization, baseline blood samples will be drawn within 2 hours. Prescribing clinician are able to access the results of the IL-6 through the internal network of the hospital. Participants' antibiotic prescription decisions will made according to the results. The detailed recommendations are as follows: if Interleukin-6\<10 pg/ml，strongly discouraged；if Interleukin-6 (10-30 pg/ml) and no sputum purulence, discouraged; if Interleukin-6 (10-30 pg/ml) and sputum purulence, Recommended; Interleukin-6\>30 pg /ml, Strongly recommended.

Group Type: EXPERIMENTAL

Interleukin 6-guided antibiotic therapy

Intervention Type: DRUG

In Interleukin-6 group, antibiotic prescription decisions will made according to the results of IL-6.

GOLD-guided antibiotic therapy (GOLD group)

After randomization, baseline blood samples will also need to be drawn within 2 hours. Prescribing clinician are able to access all results through the internal network of the hospital. Participants' antibiotic prescription decisions will made according to the recommendations of GOLD guideline. The guideline recommends antibiotic therapy for the following patients: those with COPD exacerbations presenting with all three cardinal symptoms (increased dyspnea, sputum volume, and sputum purulence); those with two of the cardinal symptoms, provided that increased purulence of sputum is one of them; or those who need mechanical ventilation (either invasive or noninvasive).

Group Type: ACTIVE_COMPARATOR

GOLD-guided antibiotic therapy

Intervention Type: DRUG

In guideline group, antibiotic prescription decisions will made according to the recommendations of GOLD guideline.

Interventions

Interleukin 6-guided antibiotic therapy

In Interleukin-6 group, antibiotic prescription decisions will made according to the results of IL-6.

Intervention Type: DRUG

GOLD-guided antibiotic therapy

In guideline group, antibiotic prescription decisions will made according to the recommendations of GOLD guideline.

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningbo No. 1 Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

依婷 Cao

Role: CONTACT

liyiting1022@163.com

+86-0574-87089878

Other Identifiers

2024-R046-02

Identifier Type: -

Identifier Source: org_study_id