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

NCT00769171 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2014-12-18

No results posted yet for this study

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

Interventions

DRUG

Avelox (Moxifloxacin, BAY12-8039)

Moxifloxacin 400 mg every 24 h

DRUG

Ceftriaxone + Metronidazole

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2006-12-31
Completion
2007-01-31

Countries

  • China
  • Hong Kong
  • Indonesia
  • Malaysia
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00769171 on ClinicalTrials.gov