Combined Diagnostic Approach for Refractory Mycoplasma Pneumonia in Children

Children's Hospital of Hebei Province

Status: Completed

Conditions: Refractory Mycoplasma Pneumoniae Pneumonia

Treatments: Procedure: Chest CT with Scoring; Other: Supportive Care; Procedure: Bronchoscopy with Bronchoalveolar Lavage; Diagnostic Test: Monocyte Subpopulation Analysis; Drug: Azithromycin, Doxycycline, Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT07064278

2022-HCH-032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Experimental: Combined Diagnostic and Therapeutic Approach

Experimental group

Description:

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.

Treatment:

Drug: Azithromycin, Doxycycline, Prednisone

Diagnostic Test: Monocyte Subpopulation Analysis

Procedure: Bronchoscopy with Bronchoalveolar Lavage

Procedure: Chest CT with Scoring

Control: Conventional Treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Azithromycin, Doxycycline, Prednisone

Other: Supportive Care