check_circleStudy Completed

Infection, intra-abdominal

Bayer Identifier:

11647

ClinicalTrials.gov Identifier:

NCT00769171

EudraCT Number:

Not Available

EU CT Number:

Not Available
Dragon study (the safety and efficacy for treatment of patients with complicated intra abdominal infections)

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
364
Trial Dates
October 2005 - January 2007
Phase
Phase 3
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Beijing, 100730, China
Completed
Beijing, 100730, China
Completed
Beijing, 100044, China
Completed
Shanghai, 200233, China
Completed
Shanghai, 200032, China
Completed
Hangzhou, 310003, China
Completed
Shanghai, 200127, China
Withdrawn
Tianjin, 300000, China
Withdrawn
Shanghai, 200127, China
Completed
Beijing, 100050, China
Completed
Seoul, 150-713, Korea, Republic Of
Completed
Uijeongbu-si, 480-130, Korea, Republic Of
Completed
Incheon, 21565, Korea, Republic Of
Withdrawn
Kaoshiung, 81346, Taiwan
Completed
Shanghai, 200080, China
Completed
Shanghai, 200092, China
Completed
Chengdu, 610041, China
Completed
Nanjing, China
Withdrawn
Tianjin, 300000, China
Completed
Bandung, 40161, Indonesia
Completed
Seoul, 110-744, Korea, Republic Of
Completed
Bucheon-si, 420-717, Korea, Republic Of
Withdrawn
Tainan, Taiwan
Completed
Hong Kong, Hong Kong
Completed
Sarawak, 93400, Malaysia
Withdrawn
Terengganu, 20400, Malaysia
Withdrawn
Taipei, Taiwan
Completed
Hong Kong, Hong Kong

Primary Outcome

  • Clinical Response
    date_rangeTime Frame:
    After 10-14 days of treatment
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Clinical and bacteriological response
    date_rangeTime Frame:
    During 3-5days of treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Bacteriological and radiological response
    date_rangeTime Frame:
    After 10-14 days of treatment
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    Safety Issue:
    yes
  • Clinical response at the TOC visit in patients with bacteriological proven intra abdominal infection
    date_rangeTime Frame:
    After 10-14 days of treatment
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    Safety Issue:
    yes
  • Mortality attributable to intra abdominal infection
    date_rangeTime Frame:
    13-28 days
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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