recurrent respiratory tract infection
Conditions
Sponsors
Guangdong Women and Children Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age 6 months to 6 years old (including boundary value), gender unlimited; (2) RRTIs was diagnosed according to the diagnostic criteria; (3) At the time of screening, the disease was in non acute infection stage or recovered from acute infection for more than 1 week; (4) The legal guardian agreed to participate in the test and signed the informed consent.
Exclusion criteria
Exclusion criteria: (1) Primary immune deficiency, acquired immune deficiency syndrome (AIDS), congenital respiratory malformation, congenital heart disease, congenital ciliated immobility syndrome, gastroesophageal reflux disease (GERD) and other primary respiratory infections. (2) Respiratory tract infection caused by pneumonia, pulmonary abscess, tuberculosis, bronchiectasis, asthma, bronchial foreign body, hyperthyroidism, rheumatic fever and other diseases. (3) In the three months before screening, immunomodulators or other drugs for RRTIs were used according to the doctor's order. (4) Diabetes, rickets, calcium / phosphorus metabolism, or severe malnutrition. (5) Serious primary diseases such as heart, liver, kidney and hematopoiesis, or abnormal examination of liver and kidney function (alt, AST >= 1.5 times of the upper limit of normal value, SCR > the upper limit of normal value). (6) Suspected or confirmed hypersensitivity to test drug components. (7) Participate in clinical trials of other drugs within one month before screening. (8) Poor compliance with the trial protocol, possible dropout / loss of follow-up (at the discretion of the investigator). (9) According to the judgment of the researchers, there are other conditions that are not suitable for the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of respiratory tract infection within one year (after medication) during the follow-up period.; | — |
Secondary
| Measure | Time frame |
|---|---|
| IgA, IgG, IgM, C3, C4;CD3+, CD4+, CD8+;Score and change of single symptom in non attack period;Number of upper and lower respiratory tract infections, proportion of respiratory tract infections, duration of infection, days of taking antibiotics, fever or not, number of hospitalizations during the trial;Medical expenses for treatment of respiratory tract infection, days of parents' absence from work and days of children's absence during the trial period; | — |
Countries
China
Contacts
Public ContactChen Yunbin
Outcome results
None listed