NCT01096511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,001

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2010

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 31, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

Enrollment Period

1.1 years

First QC Date

March 11, 2010

Last Update Submit

June 20, 2013

Conditions

Secondary PeritonitisAbscess, Intra-Abdominal

Keywords

Moxifloxacin,cIAInon-interventional

Outcome Measures

Primary Outcomes (1)

  • Types of cIAI infections

    Day 1

Secondary Outcomes (4)

  • 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

Study Arms (1)

Group 1

Drug: Moxifloxacin (Avelox, BAY12-8039)

Interventions

Moxifloxacin (Avelox, BAY12-8039)DRUG

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.

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, China

Location

MeSH Terms

Conditions

PeritonitisAbdominal Abscess

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System DiseasesAbscessSuppuration

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 11, 2010

First Posted

March 31, 2010

Study Start

December 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

June 21, 2013

Record last verified: 2013-06

Locations

CN(1)