Recurrent respiratory infections in children
Conditions
Interventions
Experimental group:Participants will receive Pidotimod solution 400 mg, twice daily (morning and evening at fasting status) orally up to Day 60.
Control group:Participants will receive placebo matched to Pidotimod solution 10ml, twice daily (morning and evening at fasting status) orally up to Day 60.
Sponsors
Shengjing Hospital of China Medical university
Eligibility
Sex/Gender
All
Age
3 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. The patients who meet the diagnosis of recurrent respiratory tract infection through clinical symptoms, signs, laboratory examination and auxiliary examination, and the course of disease is more than 1 year; 2. Patients aged 3-14 years (including the boundary value) have no gender limit; 3. The legal guardian of the subjects has signed the informed consent form (children over 10 years old and able to express their wishes independently should also sign the informed consent form); 4. Patients who did not participate in other clinical trials within 3 months.
Exclusion criteria
Exclusion criteria: 1. Known allergy or hypersensitivity reaction to Pidotimod; 2. Participants with any immunodeficiency condition, either primary or secondary, AIDS, congenital pulmonary dysplasia, congenital respiratory tract malformation or dysplasia, congenital heart disease, congenital ciliary immobility syndrome, GERD and other serious primary diseases; 3. Participants with severe malnutrition or moderate to severe anemia(HGB 1.5 times the upper limit of reference value) and abnormal renal function index (Scr > Upper limit of reference value); 9. Researchers believe that will impact effect evaluation or poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the number of respiratory tract infections within 180 days after the end of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the number of respiratory tract infections during 60 days of treatment and within 90 days after the end of treatment;Changes in the length of hospital stay due to respiratory tract infections within 60 days of treatment and within 180 days after the end of tretment;Antibiotic Use During 60 days of treatment and within 180 days after the end of treatment;Changes of immunological indexes from baseline at 60 days of treatment and 180 days after treatment; | — |
Countries
China
Contacts
Public ContactShang Yunxiao
Shengjing Hospital of China Medical University
Outcome results
None listed