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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. Identifier: NCT01096511
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : June 21, 2013
Information provided by:

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.

Condition or disease Intervention/treatment
Secondary Peritonitis Abscess, Intra-Abdominal Drug: Moxifloxacin (Avelox, BAY12-8039)

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Study Type : Observational
Actual Enrollment : 1001 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Effectiveness and Safety Study of Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)
Study Start Date : December 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Types of cIAI infections [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Cure rate [ Time Frame: 5-14 days ]
  2. Clinical signs and symptoms [ Time Frame: 5-14 days ]
  3. Duration until improvement and cure [ Time Frame: 5-14 days ]
  4. Adverse event collection [ Time Frame: 5-14 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01096511

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Many locations, China
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Medical Director, Bayer Healthcare Pharceuticals Inc. Identifier: NCT01096511    
Other Study ID Numbers: 14537
AX0910CN ( Other Identifier: company internal )
First Posted: March 31, 2010    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Keywords provided by Bayer:
Additional relevant MeSH terms:
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Intraabdominal Infections
Abdominal Abscess
Peritoneal Diseases
Digestive System Diseases
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs