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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Flexible bronchoscopy to assess airway patency, remove mucous plugs, and collect bronchoalveolar lavage (BAL) fluid for microbiological and cytological analysis.
Chest CT scans at baseline and day 14 to quantitatively assess lesion range, lesion type, pleural effusion, and lymphadenectasis (Total score: 0-13).
Flow cytometry analysis of peripheral blood to phenotype monocyte subsets (Classical, Intermediate, Non-classical) at baseline and day 14 to guide immunomodulatory therapy.
Hebei Children's Hospital
Shijiazhuang, Hebei, China
Time to fever resolution
Time in days from study enrollment until body temperature is maintained at \<37.5°C for at least 24 hours
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed at baseline and Day 14 post-treatment
Duration of hospitalization
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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%.
Management of cough, wheezing, and fever based on clinical symptoms.
Total length of stay in the hospital, measured in days.
Time frame: From date of hospital admission until date of hospital discharge, assessed up to 21 days
Duration of ICU stay
Total length of stay in the Intensive Care Unit (ICU), measured in days.
Time frame: 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.
Time frame: 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.
Time frame: Assessed at 6 months post-discharge