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

December 17, 2014 updated by: Bayer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
364

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
      • Beijing, China, 100044
      • Beijing, China, 100050
      • Beijing, China, 100730
      • Shanghai, China
      • Shanghai, China, 200032
      • Shanghai, China, 200127
      • Shanghai, China, 200233
      • Tianjin, China, 300000
    • Jiangsu
      • Nanjing, Jiangsu, China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
  • Hong Kong
      • Hong Kong, Hong Kong
    • New Territories
      • Shatin, New Territories, Hong Kong
  • Indonesia
    • West Java
      • Bandung, West Java, Indonesia, 40161
  • Korea, Republic of
      • Incheon, Korea, Republic of, 405-760
      • Seoul, Korea, Republic of, 137-701
      • Seoul, Korea, Republic of, 150-713
      • Seoul, Korea, Republic of, 420-717
    • Kyonggi-do
      • Uijeongbu, Kyonggi-do, Korea, Republic of, 480-130
  • Malaysia
      • Terengganu, Malaysia, 20400
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93400
  • Taiwan
      • Kaoshiung, Taiwan, 813
      • Tainan, Taiwan, 70428
      • Taipei, Taiwan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Clinical Response
Time Frame: After 10-14 days of treatment
After 10-14 days of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Clinical and bacteriological response
Time Frame: During 3-5days of treatment
During 3-5days of treatment
Bacteriological and radiological response
Time Frame: After 10-14 days of treatment
After 10-14 days of treatment
Clinical response at the TOC visit in patients with bacteriological proven intra abdominal infection
Time Frame: After 10-14 days of treatment
After 10-14 days of treatment
Mortality attributable to intra abdominal infection
Time Frame: 13-28 days
13-28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11647

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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