NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-121858

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedIntrauterine infection, Uterine adnexitis
Date of first enrollment01/6/2012
Target sample size30
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : DR-3355inj INN of the intervention : levofloxacin Dosage And administration of the intervention : Intravenous administration of DR-3355 injection 500 mg, 60 minutes, once a day. Control intervention name : null

Outcome(s)

Primary OutcomeClinical efficacy at the test of cure in the per protocol set Calculate the point estimation and the two sided 95% confidence interval
Secondary Outcome- 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

Key inclusion & exclusion criteria

Age minimum18
Age maximum
GenderFemale
Include criteriaPatients who meet the following criteria and have diagnosis of intrauterine infection or uterine adnexitis. 1)Patients who have a fever of over 37.0 degrees 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
Exclude criteria1)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.

Related Information

Contact

public contact
Name DAIICHISANKYO Co.,Ltd. Contact for Clinical Traial Information
Address http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html
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