Uncomplicated UTI, rUTI acute onset, no chills and fever, complicated UTI
Conditions
Interventions
Uncomplicated UTI and rUTI acute attack group:On the day of enrollment, 2 capsules (0.5g) of nelofloxacin malate were taken orally, once a day, for 3 consecutive days.
Complexity UTI Group:On the day of enrollment, 2 capsules (0.5g) of nelofloxacin malate were taken orally, once a day, for 14 consecutive days.
Sponsors
Beijing Tongren Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Patients with uncomplicated UTI, acute onset of rUTI, and complicated UTI without chills and fever, aged 18 to 79 (including 18 and 79 years old), are not limited to men and women; 2. Before the start of the trial, obtain the informed consent form approved by the ethics committee from the patient or his legal representative; 3. There are one or more symptoms of dysuria, urgency, frequent urination, suprapubic pain and the course of disease is less than 7 days; 4. No urinary tract symptoms within 4 weeks before the onset of urinary tract infection; 5. The patient has pyuria, which is confirmed by at least one of the following: urine test paper method is positive for leukocyte esterase; or flow cytometry indicates that urine leukocytes exceed the upper limit of normal; or urine sediment microscopic examination of leukocytes > 5/HP.
Exclusion criteria
Exclusion criteria: 1. Those who received effective antimicrobial treatment for more than 24 hours within 72 hours before enrollment; 2. Those who have a history of allergies to quinolone drugs, or have serious adverse reactions to quinolone drugs; 3. People who may need to continue to use antibacterial drugs to prevent after treatment (such as patients with vesicoureteral reflux); 4. Those who may use other drugs that have antibacterial, anti-inflammatory or relieve urinary tract symptoms during or before the end of the trial (including proprietary Chinese medicines, Chinese herbal medicines; other antibacterial drugs; non-steroidal anti-inflammatory drugs; a-receptor blockers) Agent, M receptor antagonist); 5. Those who have participated in other drug clinical trials within 1 month before being selected; 6. Fever (>37.3 degree C) or symptoms of upper urinary tract infection such as low back pain and percussion pain in the kidney area; 7. The patient has a urinary catheter indwelled during the treatment, and it is expected that the patient will not be able to remove it at the end of the treatment; 8. Patients with weakened immunity or immunosuppressive agents; 9. Those who are considering or confirming reproductive system infections or sexually transmitted diseases; 10. Any of the following conditions during the screening period (1) Patients with perirenal abscess or renal abscess; (2) Patients with polycystic kidney disease; (3) Patients with a history of kidney transplantation or undergoing hemodialysis or peritoneal dialysis; (4) Patients with urinary tract diversion (such as ileal loop, ureteral skin fistula); (5) Fungal urinary tract infection; (6) Recent history of various pelvic or urinary tract trauma; 11. Those who are pregnant or breastfeeding or who have planned pregnancy in the near future and who are unwilling to use effective contraceptive measures; 12. Renal insufficiency, creatinine clearance rate lower than 50ml/min; 13. Patients with a history of prolonged QTc interval, patients who need to use antiarrhythmic drugs, or patients with a history of cardiac insufficiency. The 12-lead ECG showed clinically significant abnormalities during the screening, the QTc during screening was greater than 450ms, or the potassium ion during screening was less than 3.5mmol/L/or less than the lower limit of the reference value; 14. Patients with liver disease, with ALT or AST greater than 2 times the upper limit of normal; 15. Other researchers believe that there may be any circumstances that increase the risk of subjects or interfere with clinical trials.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Resting ECG; | — |
Primary
| Measure | Time frame |
|---|---|
| Urinary tract symptoms and signs;Urine routine;Urine culture;Minimum inhibitory concentration (MIC); | — |
Countries
China
Contacts
Public ContactChen Shan
Beijing Tongren Hospital Affiliated to Capital Medical University
Outcome results
None listed