Mycoplasma pneumoniae pneumonia,fever
Conditions
Interventions
Dexibuprofen Treatment Group:treated with dexibuprofen
Ibuprofen Treatment Group:treated with ibuprofen
Sponsors
Foshan Maternity & Child Healthcare Hospital,
Eligibility
Sex/Gender
All
Age
1 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Age and Gender Both male and female children with a corrected age of 1 to 12 years (inclusive) at the time of screening are eligible. 2. Diagnostic Criteria Subjects must meet the diagnostic criteria for Mycoplasma pneumoniae pneumonia with fever (axillary temperature >= 38.5°C) as defined by the relevant expert consensus, including: Clinical Presentation: Symptoms such as fever, cough, and pulmonary rales. Radiological Evidence: Chest imaging confirming pulmonary infiltrates. Laboratory Confirmation: A positive serum MP-IgM antibody titer (>=1:160) and/or a positive MP-DNA/RNA test. 3. Informed Consent Written informed consent must be voluntarily provided by the parent(s) or legal guardian(s).
Exclusion criteria
Exclusion criteria: 1. Receipt of any antipyretic medication within 4 hours prior to screening. 2. Known hypersensitivity to dexibuprofen or ibuprofen. 3. History of asthma, bronchospasm, allergic rhinitis, urticaria, or angioedema induced by aspirin or other NSAIDs. 4. History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. 5. History of peptic ulcer or bleeding (at least two distinct episodes of ulceration or bleeding). 6. Presence of cerebral hemorrhage, other active bleeding, or high risk of bleeding. 7. Active Crohn's disease or active ulcerative colitis. 8. Presence of primary or acquired immunodeficiency diseases. 9. Presence of autoimmune diseases. 10. Presence of intracranial infection, autoimmune encephalitis, or acute disseminated encephalomyelitis. 11. Presence of central fever (e.g., due to cerebrovascular disease, hydrocephalus, brain trauma, etc.). 12. History of epileptic seizures. 13. Completion of bone marrow, stem cell, or other organ transplantation within the past 6 months, or planned transplantation during the study period, or current treatment with immunosuppressive drugs. 14. Any other significant disease that, in the investigator's judgment, may affect the trial, including but not limited to severe heart failure, severe hepatic impairment, severe renal impairment, hereditary or acquired metabolic (bone) diseases, hematologic diseases (e.g., hemophilia, thrombocytopenia), malignancy, or severe malnutrition. 15. Any of the following laboratory abnormalities at screening: a) ALT or AST >=2 × upper limit of normal (ULN), or total bilirubin >=2 × ULN. b) An increase in serum creatinine (sCr) by >=0.3 mg/dl within 2 days, or GFR <60 ml/min/1.73 m². 16. Clinically significant ECG abnormalities at screening (e.g., severe arrhythmia, changes suggestive of acute myocarditis/pericarditis, significant QTc interval prolongation). 17. Surgery within 30 days prior to screening, or planned surgery during the study period. 18. Currently hospitalized in the ICU and/or receiving mechanical ventilation. 19. Participation in any other investigational drug or device clinical trial within 30 days prior to screening. 20. Fever of unknown origin. 21. Signs of dehydration or manifestations of hyperpyrexic crisis. 22. Current use of systemic corticosteroids. 23. Co-infection with other severe bacterial or severe viral pathogens. 24. Any other condition that, in the investigator's judgment, renders the subject unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in body temperature; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comfort score;safety endpoints; | — |
Countries
China
Contacts
Public ContactBai Jun
Foshan Maternity & Child Healthcare Hospital,
Outcome results
None listed