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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00769171
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : December 18, 2014
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infection, Intra-abdominal Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Ceftriaxone + Metronidazole Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : January 2007

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

Primary Outcome Measures :
  1. Clinical Response [ Time Frame: After 10-14 days of treatment ]

Secondary Outcome Measures :
  1. Clinical and bacteriological response [ Time Frame: During 3-5days of treatment ]
  2. Bacteriological and radiological response [ Time Frame: After 10-14 days of treatment ]
  3. Clinical response at the TOC visit in patients with bacteriological proven intra abdominal infection [ Time Frame: After 10-14 days of treatment ]
  4. Mortality attributable to intra abdominal infection [ Time Frame: 13-28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00769171

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

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer HealthCare AG Identifier: NCT00769171     History of Changes
Other Study ID Numbers: 11647
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Complicated Intra-Abdominal Infections

Additional relevant MeSH terms:
Communicable Diseases
Intraabdominal Infections
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Antiprotozoal Agents
Antiparasitic Agents