臨床研究等提出・公開システム

Clinical trial of DR-3355 injection in patients with gynecological infection

DAIICHISANKYO Co.,Ltd.

http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html

Interventional

Multicenter, Open-label

3

Patients who meet the following criteria and have diagnosis of intrauterine infection or uterine adnexitis.
1)Patients who have a fever of over 37.0°C.
2)Patients who have lower abdominal pain (spontaneous pain or pressure pain)
3)Patients who have at least one of the following.
- white blood cell count increase
- CRP level increase
- presence of purulent vaginal discharge or secretory fluid
- presence of pelvic abscess confirmed by an imaging test

1)Pregnant or breastfeeding patients, patients who have the possibility of being pregnant or patients who hope for cyesis in the study drug exposure period.
2)Patients with a history of allergy or dermatological disorder to quinolone antibacterial agents.
3)Patients with severe nervous system disorder, severe cardiac impairment, severe hepatic impairment, or severe renal impairment.
4)Patients with infections caused by single pathogens which are known to be resistant or ineffective to the study drug.
5)Patients administrated other antibacterial drugs within 7 days prior to the start of the test drug, and whose symptoms have shown improvement.
6)Patients who have received levofloxacin, azithromycin, or other antibacterial drugs (more than twice, except clinical failure patients)within 7 days prior to the start of test drug administration.
7)Patients who require prohibited concomitant medications or treatment in this study.
8)Patients who participated in any other clinical trials within the previous 30 days.
9)Patients who have participated in the clinical trial of DR-3355 injection previously, and have been treated with the test drug.
10)Patients who are judged to be inappropriate by the investigator.

Female

Intrauterine infection, Uterine adnexitis

investigational material(s)
Generic name etc : DR-3355inj
INN of investigational material : levofloxacin
Therapeutic category code : 624 Synthetic antibacterials
Dosage and Administration for Investigational material : Intravenous administration of DR-3355 injection 500 mg, 60 minutes, once a day.

Clinical efficacy at the test of cure in the per protocol set
Calculate the point estimation and the two sided 95% confidence interval

- Clinical efficacy and bacteriological efficacy at the end of treatment
- Bacteriological efficacy at the test of cure
- Clinical efficacy and bacteriological efficacy at the end of injection treatment

Calculate the point estimation in the per protocol set