Clinical trial NCT00769171: Dragon Study (the Safety and Efficacy for Treatment of Patients With Complicated Intra Abdominal Infections)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection, Intra-abdominal
Keywords: Complicated Intra-Abdominal Infections
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-10-08
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical Response
timeFrame: After 10-14 days of treatment
Secondary outcomes:
measure: Clinical and bacteriological response
timeFrame: During 3-5days of treatment
measure: Bacteriological and radiological response
timeFrame: After 10-14 days of treatment
measure: Clinical response at the TOC visit in patients with bacteriological proven intra abdominal infection
timeFrame: After 10-14 days of treatment
measure: Mortality attributable to intra abdominal infection
timeFrame: 13-28 days
Other outcomes:
Locations:
city: Nanjing
country: China
state: Jiangsu
city: Chengdu
country: China
state: Sichuan
city: Hangzhou
country: China
state: Zhejiang
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Tianjin
country: China
city: Shatin
country: Hong Kong
state: New Territories
city: Hong Kong
country: Hong Kong
city: Bandung
country: Indonesia
state: West Java
city: Uijeongbu
country: Korea, Republic of
state: Kyonggi-do
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Kuching
country: Malaysia
state: Sarawak
city: Terengganu
country: Malaysia
city: Kaoshiung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: