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

This is an interventional treatment trial for Infection, Intra-abdominal focused on measuring Complicated Intra-Abdominal Infections Read More

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