CompletedNot Applicable

Combined Diagnostic Approach for Refractory Mycoplasma Pneumonia in Children

China260 participantsStarted 2022-12-01

Plain-language 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.

Who can participate

Age range

1 Year – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to fever resolution

Timeframe: 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

Timeframe: 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

Timeframe: Assessed at baseline and Day 14 post-treatment

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

Timeframe: Assessed at baseline and Day 14 post-treatment

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

Timeframe: Assessed at baseline and Day 14 post-treatment

Change in serum C-reactive protein (CRP) level

Timeframe: Assessed at baseline and Day 14 post-treatment

Trial details

NCT IDNCT07064278

SponsorChildren's Hospital of Hebei Province

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-31

View on ClinicalTrials.gov More Refractory Mycoplasma Pneumoniae Pneumonia trials

Plain-language summary

Who can participate

Age range

1 Year – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Time to fever resolution

Timeframe: 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

Timeframe: 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

Timeframe: Assessed at baseline and Day 14 post-treatment

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

Timeframe: Assessed at baseline and Day 14 post-treatment

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

Timeframe: Assessed at baseline and Day 14 post-treatment

Change in serum C-reactive protein (CRP) level

Timeframe: Assessed at baseline and Day 14 post-treatment