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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00769171
First received: October 7, 2008
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Infection, Intra-abdominal
Drug: Avelox (Moxifloxacin, BAY12-8039)
Drug: Ceftriaxone + Metronidazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Clinical Response [ Time Frame: After 10-14 days of treatment ] [ Designated as safety issue: Yes ]

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

Enrollment: 365
Study Start Date: October 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769171

Locations
China, Jiangsu
Nanjing, Jiangsu, China
China, Sichuan
Chengdu, Sichuan, China, 610041
China, Zhejiang
Hangzhou, Zhejiang, China, 310003
China
Beijing, China, 100050
Beijing, China
Beijing, China, 100044
Beijing, China, 100730
Shanghai, China, 200233
Shanghai, China
Shanghai, China, 200032
Shanghai, China, 200127
Tianjin, China, 300000
Hong Kong
Shatin, New Territories, Hong Kong
Hong Kong, Hong Kong
Indonesia
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, 420-717
Seoul, Korea, Republic of, 150-713
Malaysia
Kuching, Sarawak, Malaysia, 93400
Terengganu, Malaysia, 20400
Taiwan
Kaoshiung, Taiwan, 813
Tainan, Taiwan, 70428
Taipei, Taiwan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00769171     History of Changes
Other Study ID Numbers: 11647
Study First Received: October 7, 2008
Last Updated: June 28, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Bayer:
Complicated Intra-Abdominal Infections

Additional relevant MeSH terms:
Infection
Communicable Diseases
Intraabdominal Infections
Moxifloxacin
Ceftriaxone
Metronidazole
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
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
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 16, 2014