Phase III clinical study of DR-3355 injection in patients with surgical infection.

Phase 3

• Conditions: Surgical infection

• Registration Number: JPRN-jRCT2080221802
• Lead Sponsor: DAIICHISANKYO Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 30

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)
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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
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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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified