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

Abscess, Intra-Abdominal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096511
• Other study ID #: 14537
• Secondary ID: AX0910CN
• Status: Completed
• Phase: N/A
• First received: March 11, 2010
• Last updated: June 20, 2013
• Start date: December 2009
• Est. completion date: January 2011

Study information

• Verified date: June 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1001
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Abscess
• Abscess, Intra-Abdominal
• Intraabdominal Infections
• Peritonitis
• Secondary Peritonitis

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Types of cIAI infections		Day 1	No
Secondary	Cure rate		5-14 days	No
Secondary	Clinical signs and symptoms		5-14 days	No
Secondary	Duration until improvement and cure		5-14 days	No
Secondary	Adverse event collection		5-14 days	Yes

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