Status:
COMPLETED
Dragon Study (the Safety and Efficacy for Treatment of Patients With Complicated Intra Abdominal Infections)
Lead Sponsor:
Bayer
Conditions:
Infection, Intra-abdominal
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT00769171
Start Date
October 1 2005
End Date
January 1 2007
Last Update
December 18 2014
Active Locations (25)
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1
Nanjing, Jiangsu, China
2
Chengdu, Sichuan, China, 610041
3
Hangzhou, Zhejiang, China, 310003
4
Beijing, China, 100044