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Combined Diagnostic Approach for Refractory Mycoplasma Pneumonia in Children

NCT07064278 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-07-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Children's Hospital of Hebei Province

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07064278 on ClinicalTrials.gov