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Treatment of mycoplasma pneumoniae infection in children using the macrocyclic lactone drug azithromycin and the novel tetracycline drug doxycycline: A prospective, multicenter, randomized controlled study.

Treatment of mycoplasma pneumoniae infection in children using the macrocyclic lactone drug azithromycin and the novel tetracycline drug doxycycline: A prospective, multicenter, randomized controlled study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098426
Enrollment
Unknown
Registered
2025-03-07
Start date
2025-03-15
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

mycoplasma pneumoniae infection

Interventions

Trial 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. Children in the outpatient and emergency department; 2. Age: 5-18 years old; 3. At the same time, the following clinical manifestations are met: (1) Fever (body temperature >=37.3°C); (2) cough; 4. Onset of disease <=5 days; 5. Meet the laboratory criteria for mycoplasma infection, that is, meet any of the following: (1) Positive mycoplasma nucleic acid test: including MP-DNA or MP-RNA detection; (2) Positive mycoplasma antigen test; 6. The guardian of the subject who has signed the informed consent form has a full understanding of the purpose of the trial, a basic understanding of the pharmacological characteristics of the experimental drug and possible adverse reactions, and voluntarily allows the child to participate in the trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Doxycycline or azithromycin has been used; 2.Evidence of typical bacterial infection (clinical manifestations of coughing purulent sputum, laboratory test CRP >= 40mg/L); 3.Imaging findings: Chest X-ray or CT showing pulmonary consolidation of one or more lung lobes; 4.Respiratory failure requiring hospitalization; 5.Congenital bronchopulmonary dysplasia; 6.Serious basic diseases: including liver failure, kidney disease, heart failure, connective tissue disease, immunodeficiency disease, tumor, hypertension, diabetes, hemophagocytic syndrome, etc; 7.Contraindications for the use of azithromycin or doxycycline; 8.Children receiving other experimental drugs or instruments.

Design outcomes

Primary

MeasureTime frame
Hospitalization;

Secondary

MeasureTime frame
Remission rate and remission time of major symptoms (fever, cough, sputum, etc.);

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