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Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01096511
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : June 21, 2013
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date March 11, 2010
First Posted Date March 31, 2010
Last Update Posted Date June 21, 2013
Study Start Date December 2009
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 30, 2010)
Types of cIAI infections [ Time Frame: Day 1 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 30, 2010)
  • Cure rate [ Time Frame: 5-14 days ]
  • Clinical signs and symptoms [ Time Frame: 5-14 days ]
  • Duration until improvement and cure [ Time Frame: 5-14 days ]
  • Adverse event collection [ Time Frame: 5-14 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)
Official Title Clinical Effectiveness and Safety Study of Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult female and male patients with cIAI, who are at least 18 years of age and are scheduled to be treated with Moxifloxacin infusion, can be documented after the therapy decision has been made.
Condition
  • Secondary Peritonitis
  • Abscess, Intra-Abdominal
Intervention Drug: Moxifloxacin (Avelox, BAY12-8039)
The treatment with Moxifloxacin 400 mg infusion should comply with the recommendations written in the local product information. The decision about the treatment with Moxifloxacin as well as the duration of treatment is solely up to the attending physician.
Study Groups/Cohorts Group 1
Intervention: Drug: Moxifloxacin (Avelox, BAY12-8039)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 20, 2013)
1001
Original Estimated Enrollment
 (submitted: March 30, 2010)
1000
Actual Study Completion Date January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01096511
Other Study ID Numbers 14537
AX0910CN ( Other Identifier: company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medical Director, Bayer Healthcare Pharceuticals Inc.
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date June 2013