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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Combined Diagnostic and Therapeutic Approach | Experimental | 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. |
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| Control: Conventional Treatment | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchoscopy with Bronchoalveolar Lavage | Procedure | Flexible bronchoscopy to assess airway patency, remove mucous plugs, and collect bronchoalveolar lavage (BAL) fluid for microbiological and cytological analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to fever resolution | Time in days from study enrollment until body temperature is maintained at <37.5°C for at least 24 hours | From date of randomization until the first date of sustained (≥24 hours) temperature <37.5°C, assessed daily for up to 21 days |
| Time to cough resolution | Time in days from study enrollment until cough frequency is ≤10 coughs per day. | From date of randomization until the first date of cough frequency ≤10 per day, assessed daily for up to 21 days |
| Change in CT score | 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. | Assessed at baseline and Day 14 post-treatment |
| Change in serum Tumor Necrosis Factor-alpha (TNF-α) level | Change in serum TNF-α level from baseline to post-treatment. | Assessed at baseline and Day 14 post-treatment |
| Change in serum Interleukin-6 (IL-6) level | Change in serum IL-6 level from baseline to post-treatment. | Assessed at baseline and Day 14 post-treatment |
| Change in serum C-reactive protein (CRP) level | Change in serum CRP level from baseline to post-treatment. | Assessed at baseline and Day 14 post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospitalization | Total length of stay in the hospital, measured in days. | From date of hospital admission until date of hospital discharge, assessed up to 21 days |
| Duration of ICU stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Children's Hospital | Shijiazhuang | Hebei | 050031 | China |
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| Chest CT with Scoring | Procedure | Chest CT scans at baseline and day 14 to quantitatively assess lesion range, lesion type, pleural effusion, and lymphadenectasis (Total score: 0-13). |
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| Monocyte Subpopulation Analysis | Diagnostic Test | Flow cytometry analysis of peripheral blood to phenotype monocyte subsets (Classical, Intermediate, Non-classical) at baseline and day 14 to guide immunomodulatory therapy. |
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| Azithromycin, Doxycycline, Prednisone | Drug | Sequential azithromycin as baseline therapy. Doxycycline (4 mg/kg/day) was used if BAL results confirmed azithromycin resistance. Oral prednisone (1 mg/kg/day for 5 days) was added if intermediate monocytes were >15%. |
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| Supportive Care | Other | Management of cough, wheezing, and fever based on clinical symptoms. |
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Total length of stay in the Intensive Care Unit (ICU), measured in days.
| From date of ICU admission until date of ICU discharge, assessed up to 21 days |
| 6-month recurrence rate | Percentage of patients re-admitted for Mycoplasma pneumoniae pneumonia with positive IgM serology within 6 months of discharge. | Assessed at 6 months post-discharge |
| Quality of life score | Assessed using the Pediatric Quality of Life Inventory (PedsQL 4.0) Generic Core Scales. The questionnaire assesses physical, emotional, social, and school functioning. Scores are transformed to a 0-100 scale, where 0 is the minimum value and 100 is the maximum value. A higher score indicates a better quality of life. | Assessed at 6 months post-discharge |
| ID | Term |
|---|---|
| D011019 | Pneumonia, Mycoplasma |
| ID | Term |
|---|---|
| D009175 | Mycoplasma Infections |
| D009180 | Mycoplasmatales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018410 | Pneumonia, Bacterial |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D018893 | Bronchoalveolar Lavage |
| D017963 | Azithromycin |
| D004318 | Doxycycline |
| D011241 | Prednisone |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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