A clinical study of pazufloxacin administered at a dose of 1,000mg twice daily in patients with sepsis due to urogenital infection

A clinical study of pazufloxacin administered at a dose of 1,000mg twice daily in patients with sepsis due to urogenital infection - A clinical study of pazufloxacin in patients with sepsis due to urogenital infection

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010036

Enrollment

100

Registered

2013-02-14

Start date

2013-03-01

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

Sepsis

Interventions

Pazufloxacin is administered at a dose of 1000mg twice daily.Time course of intravenous drip infusion is over 1hour.The administration is started wuthin 1 hr at the diagnosis of sepsis. Assessment sh

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (Entry criteria) The patients diagnose clinically sepsis due to pyelonephritis,acute bacterial prostatitis and acute epididymitis with positive blood culture or suspective.SIRS can be diagnosed when two or more of these criteria are present. 1.Body temperature:greater than 38 orless than 36 2.Heart rate: greater than 90 beats per minute 3.Tachypnea(high respiratory rate): greater than 20 breaths per minute or an arterial partial presure of carbon dioxide less than 32mmHg 4.White blood cell count:greater than 12000 cells/mm3 or the presence of greater than 10% immature neutrophils band forms Procalsitonin is keasured as possible according to reference of the diagnosis of sepsis.

Exclusion criteria

Exclusion criteria: (Exclusion criteria) Complicated pyelonephritis with catheter detention (exclusion an indwelling catheter in the living body) Acute epididymitis with Chlamydia. Bacterial count Viable bacterial count before initiation of medication less than 104CFU/ml(medstream urine less than 105CFU/ml) Pyuria: Patients meeting any of the following criteria Prescribed equipment that uses non-centrifuged urine less than 10WBCs/ul Counting chamber method that uses noncentrifuged urine less than 10WBCs/mm3 Uinary test strip that uses nonentrifuged urine negative Microscopy of urinary sediment less than 5WBCs/hpf (Omission criteria) 1 Patients who has an anamnesis of hypersensitivity to the ingredient of this agent 2 Patients who has a critical obstacle of heaet,liver or kidney 3 Patients with the anamnesis of a spasm or epilepsy 4 Pregnant women or patients at a risk of pregnancy 5 Patients who are already improved with an antimicrobial agent before PZFX medication 6 Patients who admitted that a doctor in charge is unsuitable

Design outcomes

Primary

Measure	Time frame
Clinical outcome and microbiological outcome of sepsis at the end or discontinuation of administration	—

Countries

Japan

Contacts

Public ContactKiyohito Ishikawa

FUJITA HEALTH UNIVERSITY Urology

0562-93-2000

Outcome results

None listed

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