Chronic Obstructive Pulmonary Disease, COPDNCT06612476
Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients
A study testing Interleukin 6-guided antibiotic therapy and GOLD-guided antibiotic therapy in people with Chronic Obstructive Pulmonary Disease, COPD, run by Ningbo No. 1 Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD
- What is being tested?
- Interleukin 6-guided antibiotic therapy and GOLD-guided antibiotic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients: a Multicenter Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Interleukin 6-guided antibiotic therapy, GOLD-guided antibiotic therapy
- Keywords
- Aecopd, Interleukin 6, antibiotic therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin 6-guided antibiotic therapyDrug
In Interleukin-6 group, antibiotic prescription decisions will made according to the results of IL-6.
GOLD-guided antibiotic therapyDrug
In guideline group, antibiotic prescription decisions will made according to the recommendations of GOLD guideline.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: GOLD-guided antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of antibiotic use
Ratio of AECOPD patients given antibiotics
Measured: 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).
Measured: During the 30-day period after randomization
Secondary outcomes (12)
Incidence of antibiotic use
Ratio of AECOPD patients given antibiotics
Measured: During the first day period after randomization
Antibiotic utilization in the hospital
Duration of antibiotic consumption for AECOPD and the percentage of patients treated with antibiotics for AECOPD from randomization to hospital discharge
Measured: Between randomization and discharge, limited to 30 days
Duration of hospitalization
Total days of hospitalization until study completion, averaging 30 days
Measured: Between randomization and discharge, limited to 30 days
Frequency of subsequent exacerbations
Ratio of patients who develop a subsequent acute exacerbation following recovery
Measured: During the 30-day period after randomization
Incidence of hospital readmission
Ratio of patients rehospitalized for AECOPD following discharge
Measured: Between the discharge date and 30 days post-randomization
All-cause mortality
Death due to any cause
Measured: During the 30-day period after randomization
Frequency of ICU admissions
Ratio of patients admitted to the intensive care unit
Measured: During the 30-day period after randomization
noninvasive mechanical ventilation
Ratio of patients provided with non-invasive mechanical ventilation
Measured: During the 30-day period after randomization
Change in COPD assessment test
The variation from the baseline at hospital admission to 30 days after randomization
Measured: From the initial hospital admission baseline to 30 days after randomization
Change in St. George's Respiratory Questionnaire
The variation from the baseline at hospital admission to 30 days after randomization
Measured: From the initial hospital admission baseline to 30 days after randomization
Change in modified Medical Research Council (mMRC) score
The variation from the baseline at hospital admission to 30 days after randomization
Measured: From the initial hospital admission baseline to 30 days after randomization
Change in Hospital Anxiety and Depression Scale
The variation from the baseline at hospital admission to 30 days after randomization
Measured: From the initial hospital admission baseline to 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start20 Sep 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease, COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612476
- Sponsor's protocol ID
- 2024-R046-02
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06612476
- Acronym / sponsor ID
- 2024-R046-02
- Keywords
- Aecopd, Interleukin 6, antibiotic therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 20 Sep 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interleukin 6-guided antibiotic therapy (Interleukin-6 group) | Experimental | Drug: Interleukin 6-guided antibiotic therapyAfter 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. |
| GOLD-guided antibiotic therapy (GOLD group) | Active comparator | Drug: GOLD-guided antibiotic therapyAfter 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). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interleukin 6-guided antibiotic therapyIn Interleukin-6 group, antibiotic prescription decisions will made according to the results of IL-6. | Drug | Interleukin 6-guided antibiotic therapy (Interleukin-6 group) |
| GOLD-guided antibiotic therapyIn guideline group, antibiotic prescription decisions will made according to the recommendations of GOLD guideline. | Drug | GOLD-guided antibiotic therapy (GOLD group) |
Primary outcome
Incidence of antibiotic use
Time frame: During the 30-day period after randomization
Ratio of AECOPD patients given antibiotics
Proportion of successful treatments
Time frame: During the 30-day period after randomization
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).
12 secondary outcomes
Incidence of antibiotic use
Time frame: During the first day period after randomization
Antibiotic utilization in the hospital
Time frame: Between randomization and discharge, limited to 30 days
Duration of hospitalization
Time frame: Between randomization and discharge, limited to 30 days
Frequency of subsequent exacerbations
Time frame: During the 30-day period after randomization
Incidence of hospital readmission
Time frame: Between the discharge date and 30 days post-randomization
All-cause mortality
Time frame: During the 30-day period after randomization
Frequency of ICU admissions
Time frame: During the 30-day period after randomization
noninvasive mechanical ventilation
Time frame: During the 30-day period after randomization
Change in COPD assessment test
Time frame: From the initial hospital admission baseline to 30 days after randomization
Change in St. George's Respiratory Questionnaire
Time frame: From the initial hospital admission baseline to 30 days after randomization
Change in modified Medical Research Council (mMRC) score
Time frame: From the initial hospital admission baseline to 30 days after randomization
Change in Hospital Anxiety and Depression Scale
Time frame: From the initial hospital admission baseline to 30 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Interleukin 6-guided antibiotic therapy and GOLD-guided antibiotic therapy in people with Chronic Obstructive Pulmonary Disease, COPD, run by Ningbo No. 1 Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact 依婷 Cao (+86-0574-87089878, liyiting1022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of antibiotic use (time frame: During the 30-day period after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.