Comparative study of DR-3355 injection and pazufloxacin injection in patients with urinary tract infectio

Phase 3

• Conditions: rinary tract infection (Acute uncomplicated pyelonephritis, Complicated pyelonephritis, Complicated cystitis)

• Registration Number: JPRN-jRCT2080221777
• Lead Sponsor: DAIICHISANKYO Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 324

Inclusion Criteria

1) Patients between the ages of 20 to 79 at the time of obtaining informed consents.
2) Patients who require hospitalization at the time of enrollment.
3) Patients with symptoms of pyelonephritis or cystitis.
4) Patients who meet the criteria for pyuria and have bacteria in the urine
5) Patients who require an injection treatment.(any of the following symptoms: temperature of 38 degrees or more, nausea or vomiting, dehydration, suspicion of bacteremia, urine flow failure, anorexia, diarrhea)

Exclusion Criteria

1) Patients who have indwelling catheter in the urinary tract.
2) Patients whose urinary tract is routed through bowels.
3) Patients who had a prostate biopsy immediately prior to enrollment.
4) Patients whose symptoms have shown improvement due to the administration of other antibacterial agents within 7 days prior to the test drug administration.
5) Patients with infectious diseases for whom levofloxacin or pazufloxacin did not work obviously, or patients having fungus that has been detected in a bacteria test prior to this trial.
6) Patients with urinary tract infection other than target diseases (pyelonephritis or cystitis).
7) Patients who have received levofloxacin or pazufloxacin within 30 days prior to the test drug administration.
8) Patients with a history of allergy/severe adverse effects to quinolone antibacterial agents.
9) Pregnant or breastfeeding patients, or patients who have the possibility of being pregnant.
10) Patients with a history of seizure/epilepsy/disturbance of consciousness.
11) Patients who have difficulty in judging the efficacy of the study drug(including patients suffering from progressive cancer or other underlying diseases which prevent the evaluation).
12) Patients with severe hepatic impairment, renal impairment, or cardiac impairment.
13) Patients who require prohibited concomitant medications or treatments in this study.
14) Patients who participated in any other clinical trials within 30 days prior to this trial.
15) Patients who have participated in the clinical trial of DR-3355 injection previously, and have been treated with the test drug.
16) Other patients who are judged to be inappropriate by the attending urology doctor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bacteriological efficacy, safety

Secondary Outcome Measures

Name	Time	Method
Clinical efficacy