NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Urinary tract infection (Acute uncomplicated pyelonephritis, Complicated pyelonephritis, Complicated cystitis)
Date of first enrollment	20/04/2012
Target sample size	324
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : DR-3355inj(levofloxacin hydrate) INN of investigational material : levofloxacin Therapeutic category code : 624 Synthetic antibacterials Dosage and Administration for Investigational material : Once a day, intravenous administration of 500 mg control material(s) Generic name etc : Pazufloxacin Mesilate INN of investigational material : pazufloxacin Therapeutic category code : 624 Synthetic antibacterials Dosage and Administration for Investigational material : Twice a day, intravenous administration of 500 mg once

Outcome(s)

Primary Outcome	Bacteriological efficacy, safety
Secondary Outcome	Clinical efficacy

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 79age old
Gender	Both
Include 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)
Exclude 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.