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

Clinical Effectiveness and Safety Study of Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)

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.

Study Overview

• Status: Completed
• Conditions: Abscess, Intra-Abdominal; Secondary Peritonitis
• Intervention / Treatment: Drug: Moxifloxacin (Avelox, BAY12-8039)

• Study Type: Observational
• Enrollment (Actual): 1001

Contacts and Locations

Study Locations

• China
  • Many locations, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Types of cIAI infections	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: March 11, 2010
• First Submitted That Met QC Criteria: March 30, 2010
• First Posted (Estimate): March 31, 2010

Study Record Updates

• Last Update Posted (Estimate): June 21, 2013
• Last Update Submitted That Met QC Criteria: June 20, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: cIAI; non-interventional; Moxifloxacin,
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Suppuration; Abscess; Intraabdominal Infections; Peritonitis; Abdominal Abscess; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
• Other Study ID Numbers: 14537; AX0910CN (Other Identifier: company internal)