Combined Diagnostic Approach for Refractory Mycoplasma Pneumonia in Children

NCT ID: NCT07064278

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Bronchoscopy with Bronchoalveolar Lavage

Intervention Type: PROCEDURE

Flexible bronchoscopy to assess airway patency, remove mucous plugs, and collect bronchoalveolar lavage (BAL) fluid for microbiological and cytological analysis.

Chest CT with Scoring

Intervention Type: PROCEDURE

Chest CT scans at baseline and day 14 to quantitatively assess lesion range, lesion type, pleural effusion, and lymphadenectasis (Total score: 0-13).

Monocyte Subpopulation Analysis

Intervention Type: 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.

Azithromycin, Doxycycline, Prednisone

Intervention Type: 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%.

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.

Group Type: ACTIVE_COMPARATOR

Supportive Care

Intervention Type: OTHER

Management of cough, wheezing, and fever based on clinical symptoms.

Azithromycin, Doxycycline, Prednisone

Intervention Type: 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%.

Interventions

Supportive Care

Management of cough, wheezing, and fever based on clinical symptoms.

Intervention Type: OTHER

Bronchoscopy with Bronchoalveolar Lavage

Flexible bronchoscopy to assess airway patency, remove mucous plugs, and collect bronchoalveolar lavage (BAL) fluid for microbiological and cytological analysis.

Intervention Type: 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).

Intervention Type: PROCEDURE

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.

Intervention Type: DIAGNOSTIC_TEST

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%.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Hebei Province

OTHER

Sponsor Role: lead

Responsible Party

Fangfang Li

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hebei Children's Hospital

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

2022-HCH-032

Identifier Type: -

Identifier Source: org_study_id