Clinical trial NCT06612476: Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients
Official title: Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease, COPD
Keywords: Aecopd
Interleukin 6
antibiotic therapy
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 440
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of antibiotic use
timeFrame: During the 30-day period after randomization
measure: Proportion of successful treatments
timeFrame: During the 30-day period after randomization
Secondary outcomes:
measure: Incidence of antibiotic use
timeFrame: During the first day period after randomization
measure: Antibiotic utilization in the hospital
timeFrame: Between randomization and discharge, limited to 30 days
measure: Duration of hospitalization
timeFrame: Between randomization and discharge, limited to 30 days
measure: Frequency of subsequent exacerbations
timeFrame: During the 30-day period after randomization
measure: Incidence of hospital readmission
timeFrame: Between the discharge date and 30 days post-randomization
measure: All-cause mortality
timeFrame: During the 30-day period after randomization
measure: Frequency of ICU admissions
timeFrame: During the 30-day period after randomization
measure: noninvasive mechanical ventilation
timeFrame: During the 30-day period after randomization
measure: Change in COPD assessment test
timeFrame: From the initial hospital admission baseline to 30 days after randomization
measure: Change in St. George&#39;s Respiratory Questionnaire
timeFrame: From the initial hospital admission baseline to 30 days after randomization
measure: Change in modified Medical Research Council (mMRC) score
timeFrame: From the initial hospital admission baseline to 30 days after randomization
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: From the initial hospital admission baseline to 30 days after randomization
Other outcomes:
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