The prospective, non controlled, open, single and multi center clinical trial of the treatment of complicated urinary tract infections with phosphorus

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OPN-16009553

Enrollment

Unknown

Registered

2016-10-23

Start date

2017-03-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complicated urinary tract infection

Interventions

complicated urinary tract infections :oral Fosfomycin Trometamol Powder

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-70 years old, male or female; 2. voluntary subjects, the subjects signed a written informed consent; 3. diagnostic criteria for complicated urinary tract infection: positive and includes at least 1 factors combined with urine culture: indwelling catheter and stent or intermittent bladder catheterization; residual urine, 100ml; any cause of obstructive urinary tract diseases, such as bladder outlet obstruction, neurogenic bladder, stones and tumors; vesicoureteral reflux or other dysfunction; urinary diversion; chemotherapy or radiation injury urothelium; perioperative and postoperative urinary tract infection; renal insufficiency, renal transplantation diabetes, immunodeficiency and etc.

Exclusion criteria

Exclusion criteria: 1. To be known allergy for fosfomycin; 2. according to the results of drug susceptibility test subjects for drug resistance; 3. the symptoms of fever; 4. cardiac insufficiency, cardiac function grade 3-4; 5. pregnant and lactating women and women of childbearing age positive pregnancy test; 6. acute renal pelvis nephritis and acute exacerbation of chronic pyelonephritis; 7. renal insufficiency, creatinine clearance rate of less than 30ml/min; 8. liver disease, ALT or AST is greater than 2 times the upper limit of the normal value; 9. white blood cell count below 2 * 10^9/L; 10. other anti infective drugs effective application within 72 hours before the selected; 11. may use other anti infective drugs or before the end of the test; 12. malignant tumor subjects; 13. With a large number of long-term use of hormone or immunosuppressive agents; 14. With a history of epilepsy Central nervous system injury; 15. severe diarrhea; 16. in the first three months of the previous clinical trials have participated in other drugs.

Design outcomes

Primary

Measure	Time frame
clinical observation index;blood routine test;urine routine test;blood biochemistry;electrocardiogram;bacterial culture of urine;adverse event;	—

Countries

China

Contacts

Public ContactZheng Junhua

Shanghai Tenth People's Hospital

zhengjh0471@sina.com+86 13901722408

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026