Infection, Intra-abdominalPhase 3DRAGONNCT00769171
Dragon Study (the Safety and Efficacy for Treatment of Patients With Complicated Intra Abdominal Infections)
A Phase 3 study testing Avelox (Moxifloxacin, BAY12-8039) and Ceftriaxone + Metronidazole in people with Infection, Intra-abdominal, run by Bayer at 25 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Intra-abdominal
- What is being tested?
- Avelox (Moxifloxacin, BAY12-8039) and Ceftriaxone + Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 25 sitesin 6 countries
- Study dates
- Oct 2005to Jan 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
25 sites in 6 countries.
25 sites in 6 countries
China12 sites
Study site
Beijing, 100044
Study site
Beijing, 100050
Study site
Beijing, 100730
Study site
Beijing
Study site
Chengdu, Sichuan, 610041
Study site
Hangzhou, Zhejiang, 310003
Study site
Nanjing, Jiangsu
Study site
Shanghai, 200032
Study site
Shanghai, 200127
Study site
Shanghai, 200233
Study site
Shanghai
Study site
Tianjin, 300000
South Korea5 sites
Study site
Incheon, 405-760
Study site
Seoul, 137-701
Study site
Seoul, 150-713
Study site
Seoul, 420-717
Study site
Uijeongbu-si, Kyonggi-do, 480-130
Taiwan3 sites
Study site
Kaoshiung, 813
Study site
Tainan, Tainan, 70428
Study site
Taipei
Hong Kong2 sites
Study site
Hong Kong, Hong Kong
Study site
Shatin, New Territories
Malaysia2 sites
Study site
Kuching, Sarawak, 93400
Study site
Terengganu, 20400
About this study
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
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
- Being tested
- Avelox (Moxifloxacin, BAY12-8039), Ceftriaxone + Metronidazole
- Keywords
- Complicated Intra-Abdominal Infections
- Medical subject headings
- Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avelox (Moxifloxacin, BAY12-8039)Drug
Moxifloxacin 400 mg every 24 h
Ceftriaxone + MetronidazoleDrug
Ceftriaxone 2 g every 24 h and Metronidazole 500 mg every 12 h
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 | Active comparator | Not described Receives: Drug: Ceftriaxone + Metronidazole |
| Arm 1 | Experimental | Not described Receives: Drug: Avelox (Moxifloxacin, BAY12-8039) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response
Measured: After 10-14 days of treatment
Secondary outcomes (4)
Clinical and bacteriological response
Measured: During 3-5days of treatment
Bacteriological and radiological response
Measured: After 10-14 days of treatment
Clinical response at the TOC visit in patients with bacteriological proven intra abdominal infection
Measured: After 10-14 days of treatment
Mortality attributable to intra abdominal infection
Measured: 13-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startOct 2005
- Primary completionDec 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Intra-abdominalStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769171
- Sponsor's protocol ID
- 11647
- Acronym
- DRAGON
- Status last verified
- Dec 2014
- First submitted
- 7 Oct 2008
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00769171
- Acronym / sponsor ID
- DRAGON / 11647
- Conditions
- Infection, Intra-abdominal
- Keywords
- Complicated Intra-Abdominal Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 8 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 2 | Active comparator | Drug: Ceftriaxone + Metronidazole |
| Arm 1 | Experimental | Drug: Avelox (Moxifloxacin, BAY12-8039) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avelox (Moxifloxacin, BAY12-8039)Moxifloxacin 400 mg every 24 h | Drug | Arm 1 |
| Ceftriaxone + MetronidazoleCeftriaxone 2 g every 24 h and Metronidazole 500 mg every 12 h | Drug | Arm 2 |
Primary outcome
Clinical Response
Time frame: After 10-14 days of treatment
4 secondary outcomes
Clinical and bacteriological response
Time frame: During 3-5days of treatment
Bacteriological and radiological response
Time frame: 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
Mortality attributable to intra abdominal infection
Time frame: 13-28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
25 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Avelox (Moxifloxacin, BAY12-8039) and Ceftriaxone + Metronidazole in people with Infection, Intra-abdominal, run by Bayer at 25 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in China, South Korea, Taiwan, Hong Kong, Malaysia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response (time frame: After 10-14 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014.