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Combination therapy of the novel tetracycline drug doxycycline and the glucocorticoid methylprednisolone for the treatment of mycoplasma pneumoniae pneumonia in children: A prospective, multicenter, randomized controlled study.

Combination therapy of the novel tetracycline drug doxycycline and the glucocorticoid methylprednisolone for the treatment of mycoplasma pneumoniae pneumonia in children: A prospective, multicenter, randomized controlled study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104971
Enrollment
Unknown
Registered
2025-06-26
Start date
2024-12-19
Completion date
Unknown
Last updated
2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycoplasma pneumoniae pneumonia

Interventions

Experimental group:Doxycycline combined with methylprednisolone
Control group:Doxycycline

Sponsors

Children's Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Pneumonia patients who meet the hospitalization criteria (fever >= 5 days, oxygen saturation = 38.0 ?); (2) Coughing; 4.Course of disease < 10 days; 5.Meet the laboratory standards for mycoplasma infection, which means meeting any of the following criteria: (1) positive mycoplasma nucleic acid test: including MP-DNA or MP-RNA testing; (2)mycoplasma antigen test positive; 6.Meet the imaging findings: Chest X-ray or CT showing pulmonary consolidation of one or more lung lobes and no pulmonary complications such as pulmonary necrosis, pulmonary embolism, pleural effusion, etc; 7.The guardian of the subject who has signed the informed consent form fully understands the purpose of the trial, has a basic understanding of the pharmacological characteristics and possible adverse reactions of the trial drug, and voluntarily allows the child to participate in this trial and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Doxycycline or methylprednisolone has been used; 2.Contraindications for the use of methylprednisolone or doxycycline; 3.Course of fever>=10 days; 4.Existing pulmonary complications (pulmonary embolism, pulmonary necrosis, pleural effusion, plastic bronchitis, etc.); 5.Respiratory failure requiring mechanical ventilation; 6.Congenital bronchopulmonary dysplasia; 7.Serious basic diseases: including liver failure, kidney disease, heart failure, connective tissue disease, immunodeficiency disease, tumor, hypertension, diabetes, hemophagocytic syndrome, etc; 8.Children receiving other experimental drugs or instruments;

Design outcomes

Primary

MeasureTime frame
The fever reduction rate of children (with the fever subsiding and remaining normal for over 48 hours) within 5 days after enrollment;

Secondary

MeasureTime frame
Remission rate and remission time of cough;Recovery status of chest imaging (chest X-ray or CT scan);White blood cell count;C-reactive protein;Lactic dehydrogenase;Liver function;D-Dimer;Ferritin;Pulmonary necrosis;Pulmonary embolism;Pleural effusion;

Countries

China

Contacts

Public ContactChen Zhengrong

Children's Hospital of Soochow University

chenzhengrong@suda.edu.cn+86 512 80693506

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026