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Evaluation of the efficacy of biapenem for complicated urinary tract infections and the pharmacokinetic-pharmacodynamic parameter

Evaluation of the efficacy of biapenem for complicated urinary tract infections and the pharmacokinetic-pharmacodynamic parameter - Evaluation of the efficacy of biapenem for complicated urinary tract infections and the pharmacokinetic-pharmacodynamic parameter

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000003216
Enrollment
20
Registered
2010-02-22
Start date
2010-02-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

complicated urinary tract infections

Interventions

None listed

Sponsors

Department of Urology,Gifu University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.patients who are admitted to Gifu University Hospital with complicated urinary tract infections 2.20 years old or older 3.written informed consent must be obtained from patients

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
The decision of the PK-PD parameter of biapenem which is effective for complicated urinary infections disease

Countries

Japan

Contacts

Public ContactKensaku Seike

Gifu University Graduate School of Medicine Department of Urology

k.seike-04.6.26@leaf.ocn.ne.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026