Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients

Ningbo No. 1 Hospital

Status: Not yet enrolling

Conditions: Chronic Obstructive Pulmonary Disease, COPD

Treatments: Drug: Interleukin 6-guided antibiotic therapy; Drug: GOLD-guided antibiotic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06612476

2024-R046-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 440 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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440 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: Interleukin 6-guided antibiotic therapy

GOLD-guided antibiotic therapy (GOLD group)

Active Comparator group

Description:

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).

Treatment:

Drug: GOLD-guided antibiotic therapy