Infection, Intra-abdominal
Conditions
Keywords
Complicated Intra-Abdominal Infections
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.
Interventions
Moxifloxacin 400 mg every 24 h
DRUGCeftriaxone + Metronidazole
Ceftriaxone 2 g every 24 h and Metronidazole 500 mg every 12 h
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Response | After 10-14 days of treatment |
Secondary
| 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 |
Countries
China, Hong Kong, Indonesia, Malaysia, South Korea, Taiwan
Outcome results
None listed