Combined Diagnostic Approach for Refractory Mycoplasma Pneumonia in Children

NCT07064278 | Completed

• 1 other identifier: 2022-HCH-032
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Mycoplasma Pneumoniae Pneumonia

Keywords

Pediatric refractory Mycoplasma pneumoniae pneumonia; Bronchoscopy; CT score; Monocyte subpopulation; Prognosis

Outcome Measures

Primary Outcomes (6)

• Time to fever resolution

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

  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.

  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.

  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.

  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.

  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.

  Assessed at baseline and Day 14 post-treatment

Secondary Outcomes (4)

• Duration of hospitalization

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

• Duration of ICU stay

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

• 6-month recurrence rate

  Assessed at 6 months post-discharge

• Quality of life score

  Assessed at 6 months post-discharge

Study Arms (2)

Experimental: Combined Diagnostic and Therapeutic Approach

EXPERIMENTAL

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.

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

Control: Conventional Treatment

ACTIVE COMPARATOR

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.

Drug: Azithromycin, Doxycycline, Prednisone; Other: Supportive Care

Interventions

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.

Experimental: Combined Diagnostic and Therapeutic Approach

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).

Experimental: Combined Diagnostic and Therapeutic Approach

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.

Experimental: Combined Diagnostic and Therapeutic Approach

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%.

Control: Conventional Treatment; Experimental: Combined Diagnostic and Therapeutic Approach

Supportive Care OTHER

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

Control: Conventional Treatment

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Children's Hospital of Hebei Province: lead

Study Sites (1)

Hebei Children's Hospital

Shijiazhuang, Hebei, 050031, China

Location

MeSH Terms

Conditions

Pneumonia, Mycoplasma

Interventions

Bronchoalveolar Lavage; Azithromycin; Doxycycline; Prednisone; Palliative Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 14, 2025
• Study Start: December 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: July 14, 2025

Record last verified: 2025-06

Locations

CN (1)