SYNOPSIS
Name of Sponsor/Company
Name of Finished ProductName of Active Ingredient
Title of Study
Investigators
Study Centre(s)Publication (reference)
Studied Period
Phase of Development
Objectives
Methodology
Number of Patients(planned and analyzed)

Diagnosis and Main Criteria
for Inclusion

Daiichi Sankyo Co., Ltd.
CRAVIT ® INTRAVENOUS DRIP INFUSION
Levofloxacin
Clinical trial of DR-3355 injection in patients with peritonitis
14 sites
None
Date of obtaining first consent: August, 2012
Date of last observation: October, 2013
Phase 3To evaluate the efficacy and safety in patients with peritonitis
receiving a dose of 500 mg DR-3355 injection once a day.
Multicenter, Open-label study
Planned: 20 patients (As the patient that a bacteriological evaluationis possible: more than 10 subjects)
Registered: 21 patients
Analyzed:
Analysis set of efficacy (PPS) 19 subjects
Analysis set of bacteriological efficacy 14 subjects
Analysis set of PK 4 subjects
Analysis set of safety 21 subjects
Diagnosis: peritonitis (including peritonitis caused by pelvic
inflammatory disease)
Inclusion criteria:
1) Patients with age of 20 or older at the time of obtaining informed
consents
2) Inpatients
3) Patients who suffer intra-abdominal infections clinicallydemonstrated by the inflammatory, abdominal or imaging findings,
and who meet any of the following criteria.
a) Patients who are to undergo percutaneous drainage ofinfectious focus, or had received such treatment within 24hours. However, patients with PID whose treating physicians
do not perform drainage at their discretion can be also selected
as the subjects.
b) In the case of postoperative infection, patients who areconfirmed to have gastrointestinal tract fluid or purulent
exudate from the drains left during surgery.
4) Initial treatment patients or clinical failure patients with otherantimicrobial drugs.
5) Patients that the investigator can obtain a sample from forbacteriologicalExclusion criteria:
1) Traumatic injury or operative procedure within 12 hours ofsustaining a perforation during lower gastrointestinal tract
endoscopy2) Surgery within 24 hours due to ruptured gastroduodenal ulcer3) Patients who are managed by open peritoneal drainage
4) Uncomplicated appendicitis, necrotizing pancreatitis, infectiousmononucleosis, cystic fibrosis, spontaneous bacterial peritonitis,
anaerobe's feeding pathophysiology upon significant role isTest Product, Dose andMode of Administration,
Batch Number

Duration of Treatment
Reference Therapy, Doseand Mode ofAdministration, Batch
NumberCriteria for Evaluation

Statistical Method
Summary - Conclusion

expected5) Patients who are yet to receive appropriate treatment such as
drainage, despite that obvious abscess formation from perforative
peritonitis has been confirmed from diagnostic imaging6) Patients whose IAI symptoms are improving because of surgicalintervention including drainage
7) Pregnant or breastfeeding patients, patients who have thepossibility of being pregnant or patients who hope for cyesis in thestudy drug exposure period
8) Patients with a history of allergy or dermatological disorder toquinolone antibacterial agents.
9) Patients with severe nervous system disorder, severe cardiacimpairment, severe hepatic impairment, or severe renal impairment
10) Patients with infections caused by single pathogens which areknown to be resistant or ineffective to the study drug.
11) Patients administrated other antibacterial drugs within 7 days
prior to the start of the test drug, and whose symptoms have shown
improvement.
12) Patients who have received levofloxacin, azithromycin, or otherantibacterial drugs (more than twice, except clinical failure
patients) within 7 days prior to the start of test drug administration.
13) Patients who require prohibited concomitant medications in thisstudy.
14) Patients who participated in any other clinical trials within theprevious 30 days.
15) Patients who have participated in the clinical trial of DR-3355
injection previously, and have been treated with the test drug.
16) Patients who are judged to be inappropriate by the investigator.
Test product (batch number):
DR-3355 injection (D3355I0H11T01A)
Dosage and administration:
Intravenous administration of DR-3355 injection at 500 mg, once aday
Three to fourteen days
None

Primary endpoint: Clinical efficacy at the test of cure (TOC)
Secondary endpoint:- Clinical efficacy and bacteriological efficacy at the end oftreatment (EOT)- Bacteriological efficacy at the test of cure (TOC)
The point estimate of the efficacy rate and the two-sided 95%
confidence interval were calculated.
Efficacy summary:
The rate of clinical efficacy and bacteriological efficacy at TOC in
the peritonitis patients was 70.6% (12/17) and 66.7% (6/9),
respectively. The rate of clinical effect at TOC in patients thatanaerobic bacteria was found was 47.1% (8/17). In particularly, therate of clinical efficacy of the patients whom Bacteroides species wasfound was 33.3% (2/6).
The peritoneal exudate/plasma drug concentration ratio at six toeight hours after end of treatment of DR-3355 injection was 1.95.

Safety summary:
The incidence of adverse events was 71.4% (15/21), and theincidence of adverse drug reactions was 28.6% (6/21).

Date of Report

Conclusion:
From these results, DR-3355 injection is useful for treatment ofperitonitis (including peritonitis caused by pelvic inflammatory
disease), except case that anaerobe get involved an important role inpathologic condition of peritonitis, and there is no important problem
in the safety.
January 23, 2015