NCT07064278

Combined Diagnostic Approach for Refractory Mycoplasma Pneumonia in Children

Prognostic Significance of Bronchoscopy and CT Score Combined With Monocyte Subsets in Pediatric Patients With Refractory Mycoplasma Pneumoniae Pneumonia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Children's Hospital of Hebei Province · Academic / Other
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Refractory Mycoplasma Pneumoniae Pneumonia

Interventions

Type	Name	Description
PROCEDURE	Bronchoscopy with Bronchoalveolar Lavage	Flexible bronchoscopy to assess airway patency, remove mucous plugs, and collect bronchoalveolar lavage (BAL) fluid for microbiological and cytological analysis.
PROCEDURE	Chest CT with Scoring	Chest CT scans at baseline and day 14 to quantitatively assess lesion range, lesion type, pleural effusion, and lymphadenectasis (Total score: 0-13).
DIAGNOSTIC_TEST	Monocyte Subpopulation Analysis	Flow cytometry analysis of peripheral blood to phenotype monocyte subsets (Classical, Intermediate, Non-classical) at baseline and day 14 to guide immunomodulatory therapy.
DRUG	Azithromycin, Doxycycline, Prednisone	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%.
OTHER	Supportive Care	Management of cough, wheezing, and fever based on clinical symptoms.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2025-07-14
• Last updated: 2025-07-14

Locations

1 site across 1 country: China