Procalcitonin-guided Initiation of Antibiotics in AECOPD Inpatients: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 500
- 主要终点
- Antibiotic prescription rate
研究概览
简要总结
Current antibiotic prescription for patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is generally based on the Anthonisen criteria in The Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline, that has a potential risk of antibiotics overuse. The dilemma is to identify patients who are most likely to benefit from antibiotics while avoiding unnecessary antibiotic use. Procalcitonin (PCT), a more sensitive and specific biomarker of bacterial infection than other conventional laboratory tests, has the potential to determine those patients in whom antibiotics would be beneficial. It is unclear whether PCT-guided antibiotic therapy is safe and effective for inpatients with AECOPD. The investigators aim to conduct a 2-arm, multicenter randomized controlled trial in China to determine whether PCT-guided antibiotic therapy will reduce the antibiotic prescription rate for AECOPD without negatively impacting the treatment success rate, compared with the GOLD guideline antibiotic recommendations.
详细描述
This trial will recruit 500 hopitalized patients with AECOPD. The eligible participants will be randomly assigned to either PCT group or guideline group.The investigators aim to compare the efficacy and safety between PCT-gudied antibiotic therapy and guideline-guided antibiotic recommendations. The primary hypothesis is that PCT-guided antibiotic therapy will reduce the antibiotic prescription rate for AECOPD without negatively impacting the treatment success rate, compared with the GOLD guideline antibiotic recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients with AECOPD
- •≥40 years of age
- •Able to understand and communicate to ensure the completion of the trial
- •Voluntary participation and provide written informed consent
排除标准
- •Fever, Axillary temperature≥38°C
- •Pneumonia identified by X-Ray or CT of the chest
- •Severe respiratory failure requiring admittance to ICU
- •Concurrent infection at another site (e.g. urinary tract infection)
- •Immunosuppression secondary to chemotherapy, AIDS or malignant tumor of blood system
- •Comorbidities requiring corticosteroids (prednisone 30mg/d or equivalent more than 30 days )
- •Invasive mechanical ventilation
- •Patients with malignant tumors receiving chemotherapy or radiotherapy
- •Pregnancy
- •Participation in another clinical trial
- •Previously enrollment into the study
- •Refuse to attend
研究组 & 干预措施
PCT-guided antibiotic therapy (PCT group)
Participants in the PCT group will complete a PCT test within 2 hours after randomization and the results will be sent back to the clinician by laboratory through the internal network of the hospital. The prescribing clinician will use the results of the PCT to help guide their antibiotic prescription decision. The detailed recommendations are as follows: if PCT<0.1ng/ml，strongly discouraged；if PCT (0.1-0.25ng/ml) and no sputum purulence, discouraged; if PCT (0.1-0.25ng/ml) and sputum purulence, Recommended; PCT>0.25 ng/ml, Strongly recommended.
干预措施: procalcitonin-guided antibiotic therapy (Drug)
Guideline-guided antibiotic therapy (guideline group)
Participants in the guideline group will also need to complete a PCT test within 2 hours after randomization, however, the laboratory will save the results and do not sent back to the clinician. The clinician will make an antibiotic prescribing decision on the basis of the recommendations of GOLD guideline. The guideline recommend the following patients to receive antibiotic therapy. Patients with exacerbations of COPD who have three cardinal symptoms: increase in dyspnea, sputum volume, and sputum purulence; have two of the cardinal symptoms, if increased purulence of sputum is one of the two symptoms; or require mechanical ventilation (invasive or noninvasive).
干预措施: guideline-guided antibiotic therapy (Drug)
结局指标
主要结局
Antibiotic prescription rate
时间窗: within 30 days post randomization
proportion of patients receiving antibiotics for AECOPD
Treatment success rate
时间窗: day 30 post randomization
Treatment success is defined as cure (a complete resolution of signs and symptoms associated with the exacerbation) or improvement (a resolution or reduction of the symptoms and signs associated with the exacerbation, without new symptoms or signs).
次要结局
- ICU admission rate(within 30 days post randomization)
- Rate of subsequent exacerbation(within 30 days post randomization)
- Antibiotic prescription rate(day 1 post randomization)
- Hospital antibiotic exposure(from randomization to hospital discharge, up to 30 days)
- Length of hospital stay(from randomization to hospital discharge, up to 30 days)
- rate of hospital readmission(from the date of discharge to day 30 post randomization)
- overall mortality(within 30 days post randomization)
- Change in COPD assessment test(from the baseline of hospital admission to day 30 post randomization)
- Change in modified Medical Research Council (mMRC) score(from the baseline of hospital admission to day 30 post randomization)
研究者
Bin Cao
professor
Capital Medical University