Surgical infection
Conditions
Sponsors
DAIICHISANKYO Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with age of 20 or older at the time of obtaining informed consents 2) Inpatients 3) Patients who need the treatment using injection 4) Patients who satisfied the below criteria at the start of therapy, Fever, increased WBC count, marked left shift, increased CRP level, increased pulse rate, or increased respiration rate Local findings Redness, spontaneous pain/tenderness, pulsation, local warmth, swelling/induration, or discharge of pus/effusion Patients who satisfied No. or 2, and 3, and below criteria of acute cholecystitis or cholangitis, and receive initial treatment this time 1. Patients scheduled for surgery, percutaneous drainage, or biliary drainage, or done. 2. Patients confirmed bile or purulent fluid from indwelling drain 3. Malfunctioning gastrointestinal tract (ex. nausea/vomiting, hypoactive bowel sound, obstruction to the discharge of intestinal tract gas, symptoms of ileus) > At least one item in A, one or more item in B, and C A) Fever, increased WBC count, increased CRP level B) RUQ mass/pain/tenderness or Murphy's sign C) Imaging findings characteristic of acute cholecystitis > All items in A, or at least one item in A and all items in B A) Fever, abdominal pain (RUQ or upper abdominal), jaundice B) Increased serum ALP, or gamma-GT levels; increased WBC count, or increased CRP level; biliary dilatation, or evidence of an etiology (stricture, stone, etc) on imaging findings
Exclusion criteria
Exclusion criteria: 1) Patients with a history of allergy/adverse effect to quinolone antibacterial agents. 2) Patients with a history of seizure/epilepsy. 3) Pregnant or breastfeeding patients, or patients who have the possibility of being pregnant. 4) Patients with severe hepatic impairment, renal impairment, or cardiac impairment. 5) Patients with disease which is difficult in judgment of the efficacy and the safety of the study drug (including patients suffering from cancer or other underlying diseases which prevent the evaluation). 6) Patients with severe disease required ICU care or mechanical ventilator. 7) Patients required prohibited concomitant medications or treatments in this study. 8) Patients received levofloxacin or azithromycin within seven days prior to the test drug. 9) Patients received other antibacterial agents (except levofloxacin or azithromycin) within seven days prior to the test drug, however patients received antibacterials as the prophylactic drug within 3 days (including the day of operation) or once (at the time of drainage) are permitted. Furthermore, patients received antibacterials only once within 24 hours prior to the test drug are permitted. 10) Patients who resolve only with surgery. 11) Patients showing apparent improvement of symptoms/clinical findings by surgery. 12) Patients with infection by non-susceptible microbes to DR-3355 (ex. MRSA, levofloxacin resistant Escherichia coli, fungi, or virus). 13) Patients with osteomyelitis or infectious arthritis, patients with infection involving a foreign or artifactitious body who cannot remove the foreign or artifactitious body, patients with multiple infectious ulcer, patients with third-degree burn covering more than 10% of the body surface area. 14) Patients who attended any other clinical trial within 30 days prior to this trial. 15) Patients who attended clinical trial of DR-3355 injection in the past and received the drug. 16) Other patients judged to be inappropriate by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy at the test of cure The point estimate of the efficacy rate and the two-sided 95% confidence interval are calculated by diagnosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Bacteriological efficacy at the test of cure 2) Clinical efficacy and bacteriological efficacy at the end of treatment 3) Clinical efficacy and bacteriological efficacy at the end of injection's treatment The point estimate of the efficacy rate and the two-sided 95% confidence interval are calculated by diagnosis. | — |
Outcome results
None listed