1) Patients with age of 20 and over at the time of obtaining informed consents.
2) Patients with symptoms of acute prostatitis or acute epididymitis.
3) Patients who meet the criteria for pyuria and have bacteria in the urine
4) Patients who require an injection treatment.(any of the following symptoms: pain and swelling of the epididymis, temperature of 38 degrees or more, nausea or vomiting, dehydration, suspicion of bacteremia, urine flow failure, anorexia, diarrhea)
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 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 (acute prostatitis or acute epididymitis).
7) Patients who have received levofloxacin within 30 days prior to the test drug administration.
8) Patients with a history of allergy/severe adverse effects to quinolone antibacterial agents.
9) Patients with a history of seizure/epilepsy/disturbance of consciousness.
10) 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).
11) Patients with severe hepatic impairment, renal impairment, or cardiac impairment.
12) Patients who require prohibited concomitant medications or treatments in this study.
13) Patients who participated in any other clinical trials within 30 days prior to this trial.
14) Patients who have participated in the clinical trial of DR-3355 injection previously, and have been treated with the test drug.
15) Other patients who are judged to be inappropriate by the investigator.
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, 60 minutes, intravenous administration of 500 mg
Bacteriological efficacy at the test of cure
The point estimate of the bacteriological efficacy rate and the two-sided 95% confidence interval are calculated by diagnosis.
Bacteriological and clinical efficacy, and bacteriological efficacy of different types of bacteria at the end of injection treatment
Clinical efficacy and bacteriological efficacy of different types of bacteria at the test of cure
Bacteriological and clinical efficacy at the test of recurrence
The point estimate of the bacteriological/clinical efficacy rate and the two-sided 95% confidence interval are calculated by diagnosis.
