Dragon Study (the Safety and Efficacy for Treatment of Patients With Complicated Intra Abdominal Infections) (DRAGON)

A Prospective, Randomized, Double-blinded, Multi-center Trial Assessing the Safety and Efficacy of Intravenous Administration BAY12-8039 (Moxifloxacin) 400mg Every 24 h Compared to Intravenous Ceftriaxone 2g Every 24h and Metronidazole 500mg Every 12h for the Treatment of Patients With Complicated Intra-abdominal Infections

The purpose of this study is to assess the safety and efficacy of intravenous administration Moxifloxacin (BAY 12-8039) compared to intravenous ceftriaxone and metronidazole for the treatment of patients with complicated intra abdominal infections. In view of the fact that intra abdominal infections are typically polymicrobial and are often treated empirically, the selected antibacterial agent must cover the likely spectrum of bacterial pathogens. Combination antibiotics therapy has been widely used with great success.

Study Overview

• Status: Completed
• Conditions: Infection, Intra-abdominal
• Intervention / Treatment: Drug: Ceftriaxone + Metronidazole; Drug: Avelox (Moxifloxacin, BAY12-8039)

• Study Type: Interventional
• Enrollment (Actual): 364
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
  • Beijing, China, 100044
  • Beijing, China, 100050
  • Beijing, China, 100730
  • Shanghai, China
  • Shanghai, China, 200032
  • Shanghai, China, 200127
  • Shanghai, China, 200233
  • Tianjin, China, 300000
  • Jiangsu
    • Nanjing, Jiangsu, China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
• Hong Kong
  • Hong Kong, Hong Kong
  • New Territories
    • Shatin, New Territories, Hong Kong
• Indonesia
  • West Java
    • Bandung, West Java, Indonesia, 40161
• Korea, Republic of
  • Incheon, Korea, Republic of, 405-760
  • Seoul, Korea, Republic of, 137-701
  • Seoul, Korea, Republic of, 150-713
  • Seoul, Korea, Republic of, 420-717
  • Kyonggi-do
    • Uijeongbu, Kyonggi-do, Korea, Republic of, 480-130
• Malaysia
  • Terengganu, Malaysia, 20400
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93400
• Taiwan
  • Kaoshiung, Taiwan, 813
  • Tainan, Taiwan, 70428
  • Taipei, Taiwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hospitalized males or females >/= 18 years of age
• Expected duration of treatment with intravenous antibiotics in hospital is anticipated to be >/= 3 full days but not exceeding 14 days
• Ability to provide written informed consent
• Confirmed or suspected intra abdominal infection through surgical procedure or Radiological evidence. For suspected intra abdominal infection, The patient must be scheduled for a surgical procedure

Exclusion Criteria:

• Known hypersensitivity to fluoroquinolones, or other quinolones, and/or to beta lactams antibiotic drugs, or metronidazole or any of the excipients. History of tendon disease/disorder related to quinolone treatment
• Known congenital or documented acquired QT prolongation; uncorrected hypokalemia; clinically relevant bradycardia; clinically relevant heart failure with reduced left ventricular ejection fraction; previous history of symptomatic arrhythmias. Concomitant use of any of the following drugs, reported to increase the QT interval:
• Known severe end stage liver disease (Child Pugh C)
• Systemic antibacterial therapy for more than 24 h within 7 days of enrollment
• Indwelling peritoneal catheter, Pre existing ascites and presumed spontaneous bacterial peritonitis
• All pancreatic processes including pancreatic sepsis, peripancreatic sepsis, or an intra abdominal infection secondary to pancreatitis
• Traumatic perforation of the upper gastrointestinal tract (stomach, duodenum) or perforated peptic ulcer if duration of perforation is < 24 h or if operated on within 24 h of perforation
• Traumatic perforation of the small or large bowel if duration of perforation is < 12 h or if operated on within 12 h of perforation
• Transmural necrosis of the intestine due to acute embolic, thrombotic, or obstructive occlusions
• Acute cholecystitis with infection confined to the gallbladder unless there is evidence of an abscess or necrotic tissue or purulent exudate surrounding the gallbladder indicating a transition of bacteria and the inflammatory process into the abdominal cavity
• Early acute or suppurative, nonperforated appendicitis unless there is evidence of an abscess or peritoneal fluid containing leukocytes and micro organisms suggestive of regional contamination
• Infections originating from the female genital tract. Perinephric infections
• Severe, life threatening disease with a life expectancy of < 48 h or APS and APACHE scores of > 35, Known rapidly fatal underlying disease (death expected within 6 months)
• Neutropenia (neutrophil count < 1,000/microliter) caused by immunosuppressive therapy or malignancy
• Patients known to have AIDS or HIV seropositives who are receiving HAART

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 2	Drug: Ceftriaxone + Metronidazole; Ceftriaxone 2 g every 24 h and Metronidazole 500 mg every 12 h
Experimental: Arm 1	Drug: Avelox (Moxifloxacin, BAY12-8039); Moxifloxacin 400 mg every 24 h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical Response	After 10-14 days of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical and bacteriological response	During 3-5days of treatment
Bacteriological and radiological response	After 10-14 days of treatment
Clinical response at the TOC visit in patients with bacteriological proven intra abdominal infection	After 10-14 days of treatment
Mortality attributable to intra abdominal infection	13-28 days

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: October 7, 2008
• First Submitted That Met QC Criteria: October 7, 2008
• First Posted (Estimate): October 8, 2008

Study Record Updates

• Last Update Posted (Estimate): December 18, 2014
• Last Update Submitted That Met QC Criteria: December 17, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Complicated Intra-Abdominal Infections
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Intraabdominal Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Antiprotozoal Agents; Antiparasitic Agents; Moxifloxacin; Metronidazole; Ceftriaxone; Norgestimate, ethinyl estradiol drug combination
• Other Study ID Numbers: 11647

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No