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

• ClinicalTrials.gov Identifier: NCT01096511
• Recruitment Status: Completed
• First Posted: March 31, 2010
• Last Update Posted: June 21, 2013
• Sponsor: Bayer
• 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

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

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

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