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

NCT00769171 | Completed Phase 3

• 1 other identifier: 11647
• Study Type: interventional
• Target: 364
• Locations: 6 countries
• Sites: 25

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.

Conditions

Infection, Intra-abdominal

Keywords

Complicated Intra-Abdominal Infections

Outcome Measures

Primary Outcomes (1)

• Clinical Response

  After 10-14 days of treatment

Secondary Outcomes (4)

• 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

Study Arms (2)

Arm 2

ACTIVE COMPARATOR

Drug: Ceftriaxone + Metronidazole

Arm 1

EXPERIMENTAL

Drug: Avelox (Moxifloxacin, BAY12-8039)

Interventions

Avelox (Moxifloxacin, BAY12-8039) DRUG

Moxifloxacin 400 mg every 24 h

Arm 1

Ceftriaxone + Metronidazole DRUG

Ceftriaxone 2 g every 24 h and Metronidazole 500 mg every 12 h

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (25)

Unknown Facility

Nanjing, Jiangsu, China

Location

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Chengdu, Sichuan, 610041, China

Location

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Hangzhou, Zhejiang, 310003, China

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Beijing, 100044, China

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Beijing, 100050, China

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Beijing, 100730, China

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Beijing, China

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Shanghai, 200032, China

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Shanghai, 200127, China

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Shanghai, 200233, China

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Shanghai, China

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Tianjin, 300000, China

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Hong Kong, Hong Kong, Hong Kong

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Shatin, New Territories, Hong Kong

Location

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Bandung, West Java, 40161, Indonesia

Location

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Kuching, Sarawak, 93400, Malaysia

Location

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Terengganu, 20400, Malaysia

Location

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Uijeongbu-si, Kyonggi-do, 480-130, South Korea

Location

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Incheon, 405-760, South Korea

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Seoul, 137-701, South Korea

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Seoul, 150-713, South Korea

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Seoul, 420-717, South Korea

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Tainan, Tainan, 70428, Taiwan

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Kaoshiung, 813, Taiwan

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Unknown Facility

Taipei, Taiwan

Location

MeSH Terms

Conditions

Intraabdominal Infections

Interventions

Moxifloxacin; Ceftriaxone; Metronidazole

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: October 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: January 1, 2007
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

CN (12); TW (3); MY (2); HK (2); ID (1); KR (5)