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Completed

NCT Number: NCT07064278

Combined Diagnostic Approach for Refractory Mycoplasma Pneumonia in Children

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.

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Key information

Conditions

Refractory Mycoplasma Pneumoniae Pneumonia Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Lung Diseases Mycoplasma Infections Mycoplasmatales Infections Pneumonia Pneumonia, Bacterial Pneumonia, Mycoplasma Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hebei Children's Hospital

Shijiazhuang, Hebei, 050031, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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).

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.

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%.

Supportive Care

Other

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

Primary outcomes

  1. Time to fever resolution

    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 in days from study enrollment until body temperature is maintained at <37.5°C for at least 24 hours

  2. Time to cough resolution

    Time frame: From date of randomization until the first date of cough frequency ≤10 per day, assessed daily for up to 21 days

    Time in days from study enrollment until cough frequency is ≤10 coughs per day.

  3. Change in CT score

    Time frame: Assessed at baseline and Day 14 post-treatment

    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.

  4. Change in serum Tumor Necrosis Factor-alpha (TNF-α) level

    Time frame: Assessed at baseline and Day 14 post-treatment

    Change in serum TNF-α level from baseline to post-treatment.

  5. Change in serum Interleukin-6 (IL-6) level

    Time frame: Assessed at baseline and Day 14 post-treatment

    Change in serum IL-6 level from baseline to post-treatment.

  6. Change in serum C-reactive protein (CRP) level

    Time frame: Assessed at baseline and Day 14 post-treatment

    Change in serum CRP level from baseline to post-treatment.

Secondary outcomes

  1. Duration of hospitalization

    Time frame: From date of hospital admission until date of hospital discharge, assessed up to 21 days

    Total length of stay in the hospital, measured in days.

  2. Duration of ICU stay

    Time frame: From date of ICU admission until date of ICU discharge, assessed up to 21 days

    Total length of stay in the Intensive Care Unit (ICU), measured in days.

  3. 6-month recurrence rate

    Time frame: Assessed at 6 months post-discharge

    Percentage of patients re-admitted for Mycoplasma pneumoniae pneumonia with positive IgM serology within 6 months of discharge.

  4. Quality of life score

    Time frame: Assessed at 6 months post-discharge

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Hebei Province

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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