check_circleStudy Completed

Secondary Peritonitis, Abscess, Intra-Abdominal

Bayer Identifier:
14537
ClinicalTrials.gov Identifier:
NCT01096511
EudraCT Number:
Not Available
EU CT Number:
Not Available
Moxifloxacin i.v. in the treatment of Complicated Intra-Abdominal Infection (cIAI)

Trial purpose

This study is a local, prospective, open-label, company-sponsored, non interventional, multi-center study. Patients documented must suffer from a cIAI and take at least one dose of Moxifloxacin infusion.The primary objective is to define the types of cIAI infections that require Moxifloxacin i.v. therapy in China.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Patients at least 18 years of age with a diagnosis of cIAI treated with Moxifloxacin infusion with/without sequential tablet treatment can be included into the study. The local Moxifloxacin product information must be considered.
  • - Contraindications stated in the local Moxifloxacin product information. Warnings and precautions, stated in the local Moxifloxacin product information must be considered as potential exclusion criteria.

Trial summary

Enrollment Goal
1001
Trial Dates
December 2009 - January 2011
Phase
N/A
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, China

Primary Outcome

  • Types of cIAI infections
    date_rangeTime Frame:
    Day 1
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Cure rate
    date_rangeTime Frame:
    5-14 days
    enhanced_encryption
    Safety Issue:
    No
  • Clinical signs and symptoms
    date_rangeTime Frame:
    5-14 days
    enhanced_encryption
    Safety Issue:
    No
  • Duration until improvement and cure
    date_rangeTime Frame:
    5-14 days
    enhanced_encryption
    Safety Issue:
    No
  • Adverse event collection
    date_rangeTime Frame:
    5-14 days
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Clinical effectiveness and safety study of Moxifloxacin i.v. in the treatment of Complicated Intra-Abdominal Infection (cIAI)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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