RUTI
Conditions
Interventions
experimental group:V1 (Day 1)-Inject 0.5ml of "Pseudomonas aeruginosa injection" for the first time. For the next 4 weeks, take 1ml/time every week for 5 times.
control group::V1 (Day 1)-One dose of fosfomycin tromethamine for 10 days, 9 consecutive doses (serving Usage: add water (50~70ml) or other non-alcoholic beverage to each bottle, take it immediately a
follow-up 0.5-1 Years (the follow-up period starts from the day of medication).
Sponsors
Beijing Tongren Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years RUTI (2 episodes or more within 6 months before enrollment or 3 episodes or more within 1 year before enrollment, according to the most; Female patients whose recent seizures are more than 1 week apart); 2. The patient has no obvious symptoms of urinary tract irritation, and the routine white blood cell count in the middle part of the urine is normal (according to the regulations of each unit) or centrifuge microscopy <= 3HP, white blood cell esterase, nitrite negative, urine culture negative; 3. No abnormal urinary tract anatomy (such as urinary tract obstruction, stones congenital urinary tract malformations) And residual urine <= 50ml; 4. Subject or agent sign the informed consent form; 5. A clear consciousness, able to answer questions independently, and complete the research questionnaire according to the requirements of the test plan.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to the above drugs; 2. Any complicated signs of urinary tract infection or pyelonephritis (shown as low back pain, fever >= 37.3 degrees C, systemic disease); 3. Use drugs that affect immune function within 7 days before randomization (1. Immunosuppressive drugs: glucocorticoids , neurocalcin inhibitors, etc.; 2. Immune enhancing drugs: BCG, levamisole, thymosin, etc.); 4. There are basic diseases of the urinary system such as: obstruction, stones, urinary tract stricture, vesicoureteral reflux or other functional abnormalities, urinary diversion, indwelling catheter or stent, or intermittent catheterization; 5. Combination or existence of systemic lupus erythematosus, AIDS and other diseases that can cause systemic immune function abnormalities; 6. Patients with malignant tumors and mental patients; 7. Patients who are known/suspected to be pregnant, breastfeeding or planning to become pregnant within 3 months after drug withdrawal; 8. Those who have received any other experimental drug treatment or participated in another interventional clinical trial within 4 weeks before screening; 9. Failure to comply with the trial protocol or other situations deemed unsuitable by the investigator.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Urine routine;Urine culture;Record of urinary tract symptoms;Time to relapse;Recurrence rate;Resistance rate of pathogenic bacteria after recurrence.; | — |
Primary
| Measure | Time frame |
|---|---|
| Urine SIgA.;Determination of T cell subsets in peripheral blood; | — |
Countries
China
Contacts
Public ContactShan Chen
Outcome results
None listed