Prognostic Significance of Bronchoscopy and CT Score Combined With Monocyte Subsets in Pediatric Patients With Refractory Mycoplasma Pneumoniae Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Time to fever resolution
研究概览
简要总结
This study evaluates whether a combined approach using bronchoscopy, chest CT scoring, and monocyte subpopulation analysis can improve clinical outcomes for children with refractory Mycoplasma pneumoniae pneumonia (RMPP) when compared to conventional treatment. The goal is to determine if this multi-dimensional assessment can lead to more personalized and effective treatment, resulting in shorter recovery times, lower recurrence rates, and better quality of life.
详细描述
Refractory Mycoplasma pneumoniae pneumonia (RMPP) is a significant clinical challenge in pediatrics, characterized by persistent symptoms despite standard macrolide therapy. This condition often results from a combination of pathogen resistance and excessive host inflammatory responses. Traditional management often fails to adequately assess airway obstruction, quantify lung damage, or characterize the patient's immune status, leading to delayed or suboptimal interventions. This single-center, prospective, randomized controlled trial was designed to address these gaps. A total of 260 children with RMPP were randomly assigned to either an experimental group or a control group. The control group received conventional treatment with sequential azithromycin. The experimental group received conventional treatment plus interventions guided by a multi-dimensional assessment: bronchoscopy with lavage to clear airways and guide antibiotic choice, CT scoring to quantify lung lesion severity and adjust treatment intensity, and monocyte subpopulation analysis to guide immunomodulatory therapy (e.g., corticosteroids). The study hypothesis is that this integrated, personalized approach will significantly improve clinical prognosis, reduce symptom duration and hospitalization, and enhance long-term outcomes compared to standard care.
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
- None
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 1-12 years.
- •Diagnosed with Mycoplasma pneumoniae pneumonia (MPP) based on clinical symptoms (persistent cough, fever ≥38.5°C for ≥5 days), positive serological tests (IgM antibodies ≥1:160), and chest imaging findings (consolidation or ground-glass opacity).
- •Defined as refractory MPP, with no improvement or worsening of symptoms (e.g., fever duration >7 days, increasing respiratory distress) after ≥7 days of standard macrolide therapy.
排除标准
- •Presence of severe comorbidities (e.g., congenital heart disease, primary immunodeficiency, chronic lung disease).
- •Confirmed bacterial or viral coinfection.
- •Known allergies to macrolides or sedatives used for bronchoscopy.
- •Guardians refused to provide informed consent.
- •Deemed unfit for bronchoscopy (e.g., unstable hemodynamics).
研究组 & 干预措施
Experimental: Combined Diagnostic and Therapeutic Approach
Participants received conventional treatment (supportive care and sequential azithromycin therapy) plus interventions guided by a multi-dimensional assessment. Treatment adjustments were made based on bronchoscopy, CT scoring, and monocyte analysis results. These included: removal of mucous plugs, switching to doxycycline for azithromycin resistance, and adding prednisone for excessive inflammation.
干预措施: Bronchoscopy with Bronchoalveolar Lavage (Procedure)
Experimental: Combined Diagnostic and Therapeutic Approach
Participants received conventional treatment (supportive care and sequential azithromycin therapy) plus interventions guided by a multi-dimensional assessment. Treatment adjustments were made based on bronchoscopy, CT scoring, and monocyte analysis results. These included: removal of mucous plugs, switching to doxycycline for azithromycin resistance, and adding prednisone for excessive inflammation.
干预措施: Chest CT with Scoring (Procedure)
Experimental: Combined Diagnostic and Therapeutic Approach
Participants received conventional treatment (supportive care and sequential azithromycin therapy) plus interventions guided by a multi-dimensional assessment. Treatment adjustments were made based on bronchoscopy, CT scoring, and monocyte analysis results. These included: removal of mucous plugs, switching to doxycycline for azithromycin resistance, and adding prednisone for excessive inflammation.
干预措施: Monocyte Subpopulation Analysis (Diagnostic Test)
Experimental: Combined Diagnostic and Therapeutic Approach
Participants received conventional treatment (supportive care and sequential azithromycin therapy) plus interventions guided by a multi-dimensional assessment. Treatment adjustments were made based on bronchoscopy, CT scoring, and monocyte analysis results. These included: removal of mucous plugs, switching to doxycycline for azithromycin resistance, and adding prednisone for excessive inflammation.
干预措施: Azithromycin, Doxycycline, Prednisone (Drug)
Control: Conventional Treatment
Participants received conventional treatment, including supportive care and sequential azithromycin therapy. The regimen consisted of intravenous azithromycin (10 mg/kg/day) for 5 days, followed by a 4-day break and then oral azithromycin for 3 days, repeated for 3 cycles (total duration: 21 days). Supportive care for both groups included antitussives, bronchodilators, and antipyretics as needed.
干预措施: Azithromycin, Doxycycline, Prednisone (Drug)
Control: Conventional Treatment
Participants received conventional treatment, including supportive care and sequential azithromycin therapy. The regimen consisted of intravenous azithromycin (10 mg/kg/day) for 5 days, followed by a 4-day break and then oral azithromycin for 3 days, repeated for 3 cycles (total duration: 21 days). Supportive care for both groups included antitussives, bronchodilators, and antipyretics as needed.
干预措施: Supportive Care (Other)
结局指标
主要结局
Time to fever resolution
时间窗: From date of randomization until the first date of sustained (≥24 hours) temperature <37.5°C, assessed daily for up to 21 days
Time in days from study enrollment until body temperature is maintained at \<37.5°C for at least 24 hours
Time to cough resolution
时间窗: From date of randomization until the first date of cough frequency ≤10 per day, assessed daily for up to 21 days
Time in days from study enrollment until cough frequency is ≤10 coughs per day.
Change in CT score
时间窗: Assessed at baseline and Day 14 post-treatment
The change in the total chest CT score from baseline to 14 days post-treatment. The score assesses lesion range, lesion type, pleural effusion, and lymphadenectasis. The score ranges from 0-13, where a lower score indicates less severe lung involvement; thus, a greater reduction in the score indicates a better outcome.
Change in serum Tumor Necrosis Factor-alpha (TNF-α) level
时间窗: Assessed at baseline and Day 14 post-treatment
Change in serum TNF-α level from baseline to post-treatment.
Change in serum Interleukin-6 (IL-6) level
时间窗: Assessed at baseline and Day 14 post-treatment
Change in serum IL-6 level from baseline to post-treatment.
Change in serum C-reactive protein (CRP) level
时间窗: Assessed at baseline and Day 14 post-treatment
Change in serum CRP level from baseline to post-treatment.
次要结局
- Duration of hospitalization(From date of hospital admission until date of hospital discharge, assessed up to 21 days)
- Duration of ICU stay(From date of ICU admission until date of ICU discharge, assessed up to 21 days)
- 6-month recurrence rate(Assessed at 6 months post-discharge)
- Quality of life score(Assessed at 6 months post-discharge)
研究者
Fangfang Li
Principal Investigator
Children's Hospital of Hebei Province