Evaluation of the efficacy of biapenem for complicated urinary tract infections and the pharmacokinetic-pharmacodynamic parameter
- Conditions
- complicated urinary tract infections
- Registration Number
- JPRN-UMIN000003216
- Lead Sponsor
- Department of Urology,Gifu University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Not provided
1.The patients who need surgical management or drainage 2.any severe rapidly progressive disease(ex. Central Nerve System disease,advanced malignant neoplasms) 3.Case clearly has a poor prognosis 4.inadequate liver or renal function 6.history of serious allergy to study therapy 7.case that valproic acid formulation (anticonvulsant) is given to or the case with the central nerve disorder such as epilepsy 8.pregnancy orlactation in women 9.treatment with a systemic antimicrobial agent prior to the baseline urine culture 10.The case (chlamydia, a fungus) that the effect of the study drug is hard to expect from an aspect of the susceptibility for an infection due to the pathogen resistant in BIPM 11.Patients with prostatic hyperplasia postoperative infection that occurred (TUR-P) within one month (however, it is assumed that the patients whom total prostatectomy was performed in by prostate cancer are possible) 12. The patients (however, it is assumed that the patients whom ureterocutaneous fistula technique was performed in are possible) whom intestinal use urinary diversion technique (ileal conduits) was performed in 13.Urethritis, prostatitis, epididymitis perinephric or intrarenal abscess 14.The case that excluded by the judgment of the person in charge
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The decision of the PK-PD parameter of biapenem which is effective for complicated urinary infections disease
- Secondary Outcome Measures
Name Time Method