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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00769171

Collaborator

(none)

364

Enrollment

Locations

Arms

Duration (Months)

14.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection, Intra-abdominal	Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Ceftriaxone + Metronidazole	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

364 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2005

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Jan 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 2	Drug: Ceftriaxone + Metronidazole Ceftriaxone 2 g every 24 h and Metronidazole 500 mg every 12 h
Experimental: Arm 1	Drug: Avelox (Moxifloxacin, BAY12-8039) Moxifloxacin 400 mg every 24 h

Arm

Intervention/Treatment

Active Comparator: Arm 2

Drug: Ceftriaxone + Metronidazole

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

Experimental: Arm 1

Drug: Avelox (Moxifloxacin, BAY12-8039)

Moxifloxacin 400 mg every 24 h

Outcome Measures

Primary Outcome Measures

Clinical Response [After 10-14 days of treatment]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Nanjing	Jiangsu	China
2	Chengdu	Sichuan	China	610041
3	Hangzhou	Zhejiang	China	310003
4	Beijing		China	100044
5	Beijing		China	100050
6	Beijing		China	100730
7	Beijing		China
8	Shanghai		China	200032
9	Shanghai		China	200127
10	Shanghai		China	200233
11	Shanghai		China
12	Tianjin		China	300000
13	Shatin	New Territories	Hong Kong
14	Hong Kong		Hong Kong
15	Bandung	West Java	Indonesia	40161
16	Uijeongbu	Kyonggi-do	Korea, Republic of	480-130
17	Incheon		Korea, Republic of	405-760
18	Seoul		Korea, Republic of	137-701
19	Seoul		Korea, Republic of	150-713
20	Seoul		Korea, Republic of	420-717
21	Kuching	Sarawak	Malaysia	93400
22	Terengganu		Malaysia	20400
23	Kaoshiung		Taiwan	813
24	Tainan		Taiwan	70428
25	Taipei		Taiwan