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

Completed

• Conditions: Secondary Peritonitis; Abscess, Intra-Abdominal
• Interventions: Drug: Moxifloxacin (Avelox, BAY12-8039)

• Registration Number: NCT01096511
• Lead Sponsor: Bayer

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 available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-03-31
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-20
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1001

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Moxifloxacin (Avelox, BAY12-8039)	-

Primary Outcome Measures

Name	Time	Method
Types of cIAI infections	Day 1

Secondary Outcome Measures

Name	Time	Method
Cure rate	5-14 days
Clinical signs and symptoms	5-14 days
Duration until improvement and cure	5-14 days
Adverse event collection	5-14 days