Used for adjuvant treatment of chronic or recurrent respiratory and urinary tract infections
Conditions
Interventions
experimental group:Give conventional treatment medicines while taking Pidimod dispersible tablets.
control group:Give conventional treatment drugs while taking placebo.
Sponsors
Shengjing Hospital of China Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Aged 18-70 years (including 18 and 70 years), regardless of gender (subject to the day of signing the informed consent); (2) The body mass index (BMI) is between 18-28 kg / m2 (including 18 kg / m2 and 28kg / m2), and the body weight is between 45-90kg (including 45kg and 90kg, the calculation formula = weight / height2); (3) Meet the diagnostic criteria for recurrent urinary tract infections (Chinese expert consensus on the diagnosis and treatment of urinary tract infections): patients with urinary tract infections >= 2 times within 6 months (excluding the current screening), and patients who require antimicrobial treatment ; (4) Subjects who have not used antibacterial drugs for 48 hours before screening, or who have used antibacterial drugs but still have obvious signs of infection; (5) Having at least one symptom of urinary tract infection, including dysuria, urinary frequency, urgency, hematuria, back pain, tenderness of the costal rib angle, suprapubic tenderness, etc.; (6) The number of leukocytes in the mid-clean urine sediment > 5 / HP; (7) Women of reproductive age and male subjects agreed and promised to use effective contraceptive measures (such as condoms, intrauterine devices, contraceptive rings, ligations, abstinence, etc.) throughout the trial period (from the beginning of the signed informed consent to the last visit); Contraceptive methods are not included); (8) Willing to participate in and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) Those who have a positive urine fungal test; (2) Have used immunosuppressants or immune enhancers within 2 weeks before screening; (3) Have a history of allergies to the test preparation or its excipients (lactose, microcrystalline cellulose, silicon dioxide, povidone K30, aspartame, sweet orange flavor, sodium starch glycolate, magnesium stearate); (4) Have a history of allergies to the test preparation or its excipients (lactose, microcrystalline cellulose, silicon dioxide, povidone K30, aspartame, sweet orange flavor, sodium starch glycolate, magnesium stearate); (5) Diabetics with unstable blood sugar control; (6) Congenital immunodeficiency (high IgE syndrome); (7) Patients with a history of major gastrointestinal surgery or disease that may alter the absorption and activity of the drug in the body (including active peptic ulcer, inflammatory bowel disease, lactose intolerance, malabsorption syndrome); (8) Those with inherited fructose intolerance and glucose-galactose malabsorption; (9) According to the judgment of the investigator, there are serious heart, brain, liver, kidney, hematopoietic system and other diseases, including serum AST / ALT more than twice the upper limit of the normal range and Cr exceeding the upper limit of the normal range, 12-lead ECG Prompt QT interval is prolonged and has clinical significance, arrhythmia or acute myocardial ischemia, etc.; (10) Those with a history of central nervous system diseases and epilepsy, and / or mental states that cannot cooperate; (11) Patients with malignant tumors; (12) Women who are pregnant, breastfeeding, or may become pregnant in the study and cannot take effective contraceptive measures; (13) (14) Past alcoholism (that is, men drink more than 28 standard units per week and women drink more than 21 standard units per week) (1 standard unit contains 14g alcohol, such as 360 ml beer or 45 ml spirits with 40% alcohol Or 150 ml wine); (15) Those who are expected to use other antibiotics and antibacterial drugs in combination during the trial; (16) Patients who participated in other clinical trials or are participating in other clinical trials within 3 months before the first dose of the trial; (17) The researchers believe that it is not appropriate to be included in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of recurrences of urinary tract infection within 6 months after the end of medication.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time for the first recovery of urinary tract infection from the screening period;;The interval of the first recurrent urinary tract infection after recovery;;CD4 +, CD8 +, CD4 + / CD8 + values of T lymphocyte subsets on day 61 of the experiment;Immunoglobulin (IgA, IgG, IgM) values on day 61 of the test; | — |
Countries
China
Contacts
Public ContactZheng Huixiao
The Second Affiliated Hosptial of Xingtai Medical College
Outcome results
None listed