Refractory Mycoplasma Pneumoniae PneumoniaNCT07064278
Combined Diagnostic Approach for Refractory Mycoplasma Pneumonia in Children
A study testing Bronchoscopy with Bronchoalveolar Lavage, Chest CT with Scoring and Monocyte Subpopulation Analysis in people with Refractory Mycoplasma Pneumoniae Pneumonia, run by Children's Hospital of Hebei Province at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Refractory Mycoplasma Pneumoniae Pneumonia
- What is being tested?
- Bronchoscopy with Bronchoalveolar Lavage, Chest CT with Scoring and Monocyte Subpopulation Analysis
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Significance of Bronchoscopy and CT Score Combined With Monocyte Subsets in Pediatric Patients With Refractory Mycoplasma Pneumoniae Pneumonia
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.
Read the 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.
- Being tested
- Bronchoscopy with Bronchoalveolar Lavage, Chest CT with Scoring, Monocyte Subpopulation Analysis, Azithromycin, Doxycycline, Prednisone, Supportive Care
- Keywords
- Pediatric refractory Mycoplasma pneumoniae pneumonia, Bronchoscopy, CT score, Monocyte subpopulation, Prognosis
- Medical subject headings
- Pneumonia, Mycoplasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy with Bronchoalveolar LavageProcedure or surgery
Flexible bronchoscopy to assess airway patency, remove mucous plugs, and collect bronchoalveolar lavage (BAL) fluid for microbiological and cytological analysis.
Chest CT with ScoringProcedure or surgery
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 AnalysisDiagnostic 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, PrednisoneDrug
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 CareOther
Management of cough, wheezing, and fever based on clinical symptoms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Azithromycin, Doxycycline, Prednisone; Other: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to fever resolution
Time in days from study enrollment until body temperature is maintained at <37.5°C for at least 24 hours
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at baseline and Day 14 post-treatment
Secondary outcomes (4)
Duration of hospitalization
Total length of stay in the hospital, measured in days.
Measured: From date of hospital admission until date of hospital discharge, assessed up to 21 days
Duration of ICU stay
Total length of stay in the Intensive Care Unit (ICU), measured in days.
Measured: From date of ICU admission until date of ICU discharge, assessed up to 21 days
6-month recurrence rate
Percentage of patients re-admitted for Mycoplasma pneumoniae pneumonia with positive IgM serology within 6 months of discharge.
Measured: Assessed at 6 months post-discharge
Quality of life score
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.
Measured: Assessed at 6 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Dec 2022
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Mycoplasma Pneumoniae PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Hebei Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fangfang Li, Children's Hospital of Hebei Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064278
- Sponsor's protocol ID
- 2022-HCH-032
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance of Bronchoscopy and CT Score Combined With Monocyte Subsets in Pediatric Patients With Refractory Mycoplasma Pneumoniae Pneumonia
- ClinicalTrials.gov ID
- NCT07064278
- Acronym / sponsor ID
- 2022-HCH-032
- Keywords
- Pediatric refractory Mycoplasma pneumoniae pneumonia, Bronchoscopy, CT score, Monocyte subpopulation, Prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Children's Hospital of Hebei ProvinceUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Combined Diagnostic and Therapeutic Approach | Experimental | Procedure: Bronchoscopy with Bronchoalveolar Lavage, Procedure: Chest CT with Scoring, Diagnostic Test: Monocyte Subpopulation Analysis, Drug: Azithromycin, Doxycycline, PrednisoneParticipants 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. |
| Control: Conventional Treatment | Active comparator | Drug: Azithromycin, Doxycycline, Prednisone, Other: Supportive CareParticipants 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. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscopy with Bronchoalveolar LavageFlexible bronchoscopy to assess airway patency, remove mucous plugs, and collect bronchoalveolar lavage (BAL) fluid for microbiological and cytological analysis. | Procedure or surgery | Experimental: Combined Diagnostic and Therapeutic Approach |
| Chest CT with ScoringChest CT scans at baseline and day 14 to quantitatively assess lesion range, lesion type, pleural effusion, and lymphadenectasis (Total score: 0-13). | Procedure or surgery | Experimental: Combined Diagnostic and Therapeutic Approach |
| Monocyte Subpopulation AnalysisFlow cytometry analysis of peripheral blood to phenotype monocyte subsets (Classical, Intermediate, Non-classical) at baseline and day 14 to guide immunomodulatory therapy. | Diagnostic test | Experimental: Combined Diagnostic and Therapeutic Approach |
| Azithromycin, Doxycycline, PrednisoneSequential 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%. | Drug | Control: Conventional Treatment, Experimental: Combined Diagnostic and Therapeutic Approach |
| Supportive CareManagement of cough, wheezing, and fever based on clinical symptoms. | Other | Control: Conventional Treatment |
Primary outcome
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
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.
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.
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.
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.
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.
4 secondary outcomes
Duration of hospitalization
Time frame: From date of hospital admission until date of hospital discharge, assessed up to 21 days
Duration of ICU stay
Time frame: From date of ICU admission until date of ICU discharge, assessed up to 21 days
6-month recurrence rate
Time frame: Assessed at 6 months post-discharge
Quality of life score
Time frame: Assessed at 6 months post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy with Bronchoalveolar Lavage, Chest CT with Scoring and Monocyte Subpopulation Analysis in people with Refractory Mycoplasma Pneumoniae Pneumonia, run by Children's Hospital of Hebei Province at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.