NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Peritonitis (include pelvic peritonitis)
Date of first enrollment	07/06/2012
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	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

Outcome(s)

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

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Patients who require hospitalization 2) Patients who suffer intra-abdominal infections clinically demonstrated by the inflammatory, abdominal or imaging findings, and who meet any of the following criteria. i) Patients who are to undergo percutaneous drainage of infectious focus, or had received such treatment within 24 hours. However, patients with pelvic inflammatory disease whose treating physicians do not perform drainage at their discretion can be also selected as the subjects. ii) In the case of postoperative infection, patients who are confirmed to have gastrointestinal tract fluid or purulent exudate from the drains left during surgery. 3) Initial treatment patients or clinical failure patients with other antimicrobial drugs. 4) Patients that the investigator can obtain a sample from for bacteriological evaluation prior to the start of the test drug or within 24 hours of the test drug administration.
Exclude criteria	1) Patients with gastrointestinal tract perforation operated on within 12 hours or gastric duodenal perforation operated on within 24 hours. 2) Patients who are managed by open peritoneal drainage. 3) Patients with the following diseases (include suspicion) i) simple appendicitis, ii) necrotizing pancreatitis, iii) infectious mononucleosis, iv) cystic fibrosis, v) spontaneous bacterial peritonitis, vi) peritonitis which is involved in anaerobic bacterium 4) Patients without appropriate procedure such as drainage despite abscess formation confirmed by imaging studies. 5) Patients who have shown improvement in symptoms because of surgical treatment. 6) Pregnant or breastfeeding patients, patients who have the possibility of being pregnant or patients who hope for cyesis in the study drug exposure period. 7) Patients with a history of allergy or dermatological disorder to quinolone antibacterial agents. 8) Patients with severe nervous system disorder, severe cardiac impairment, severe hepatic impairment, or severe renal impairment. 9) Patients with infections caused by single pathogens which are known to be resistant or ineffective to the study drug. 10) Patients administrated other antibacterial drugs within 7 days prior to the start of the test drug, and whose symptoms have shown improvement. 11) Patients who 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. 12) Patients who require prohibited concomitant medications in this study. 13) Patients who participated in any other clinical trials within the previous 30 days. 14) Patients who have participated in the clinical trial of DR-3355 injection previously, and have been treated with the test drug. 15) Patients who are judged to be inappropriate by the investigator.