lower respiratory tract infection with fever
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All participants must meet the following inclusion criteria: (1) Children whose parents or legal guardians have signed the informed consent form; (2) Patients aged 1–9 years, regardless of gender; (3) Meeting the diagnostic criteria for acute lower respiratory tract infections as outlined in Zhu Futang's Practical Pediatrics, including acute bronchitis and pneumonia (bronchopneumonia, lobar pneumonia); (4) Presenting with fever symptoms, with an axillary temperature between 38.5°C and 41°C; (5) The time since the first onset of clinical symptoms in this episode is <=7 days.
Exclusion criteria
Exclusion criteria: The following conditions will exclude participants from the clinical trial: (1) Use of antipyretic drugs within the past 6 hours; (2) Use of hormonal medications within the past 72 hours; (3) Severe pneumonia; (4) Severe malnutrition; (5) Accompanied by heart failure or other organ dysfunction; (6) Signs of dehydration; (7) History of hyperthermia crisis within the past 6 months; (8) Gastrointestinal diseases (e.g., ulcerative colitis, Crohn's disease, etc.); (9) Bleeding tendency; (10) Allergy to this class of drugs; asthma, rhinitis, or urticaria induced by aspirin or other non-steroidal anti-inflammatory drugs; (11) Chronic diseases of the liver, kidneys, endocrine system (e.g., uncontrolled diabetes, etc.), blood, heart, respiratory system, genetic metabolic disorders, or other critical illnesses; (12) Central nervous system diseases; (13) Rheumatic or autoimmune diseases (e.g., systemic lupus erythematosus, mixed connective tissue disease, etc.); (14) Participation in other drug clinical trials within 1 month before screening; (15) Other conditions deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body temperature 4 hours after administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with normal body temperature (<=37.2°C) at 4 hours after administration;change in body temperature at 6 hours after administration;average time to normalization of body temperature (<=37.2°C);change in fever comfort score; | — |
Countries
China
Contacts
Department of Pediatrics, Xijing Hospital, the Fourth Military Medical University, Xi'an, China