Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients

NCT06612476 | Not Yet Recruiting

• 1 other identifier: 2024-R046-02
• Study Type: interventional
• Target: 440
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease, COPD

Keywords

Aecopd; Interleukin 6; antibiotic therapy

Outcome Measures

Primary Outcomes (2)

• Incidence of antibiotic use

  Ratio of AECOPD patients given antibiotics

  During the 30-day period after randomization

• Proportion of successful treatments

  Treatment success is achieved when there is a cure (full resolution of all symptoms and signs of the exacerbation) or improvement (diminishment or resolution of symptoms and signs from the exacerbation, with no additional symptoms or signs).

  During the 30-day period after randomization

Secondary Outcomes (12)

• Incidence of antibiotic use

  During the first day period after randomization

• Antibiotic utilization in the hospital

  Between randomization and discharge, limited to 30 days

• Duration of hospitalization

  Between randomization and discharge, limited to 30 days

• Frequency of subsequent exacerbations

  During the 30-day period after randomization

• Incidence of hospital readmission

  Between the discharge date and 30 days post-randomization

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: Interleukin 6-guided antibiotic therapy

GOLD-guided antibiotic therapy (GOLD group)

ACTIVE COMPARATOR

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).

Drug: GOLD-guided antibiotic therapy

Interventions

Interleukin 6-guided antibiotic therapy DRUG

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

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

GOLD-guided antibiotic therapy DRUG

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

GOLD-guided antibiotic therapy (GOLD group)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

依婷 Cao

CONTACT

+86-0574-87089878; liyiting1022@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: September 25, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share