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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01096511
First received: March 11, 2010
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

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 Intervention
Secondary Peritonitis
Abscess, Intra-Abdominal
Drug: Moxifloxacin (Avelox, BAY12-8039)

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Types of cIAI infections [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cure rate [ Time Frame: 5-14 days ] [ Designated as safety issue: No ]
  • Clinical signs and symptoms [ Time Frame: 5-14 days ] [ Designated as safety issue: No ]
  • Duration until improvement and cure [ Time Frame: 5-14 days ] [ Designated as safety issue: No ]
  • Adverse event collection [ Time Frame: 5-14 days ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

n.a.


Enrollment: 1001
Study Start Date: December 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096511

Locations
China
Many locations, China
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Director, Bayer Healthcare Pharceuticals Inc.
ClinicalTrials.gov Identifier: NCT01096511     History of Changes
Other Study ID Numbers: 14537, AX0910CN
Study First Received: March 11, 2010
Last Updated: June 20, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Bayer:
Moxifloxacin,
cIAI
non-interventional

Additional relevant MeSH terms:
Abdominal Abscess
Intraabdominal Infections
Peritonitis
Infection
Peritoneal Diseases
Digestive System Diseases
Abscess
Suppuration
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on October 19, 2014