Greatest International Antiinfective Trial With Avelox (GIANT)

November 16, 2012 updated by: Bayer

GIANT - Greatest International Antiinfective Trial With Avelox®

The observation period for each patient covered an initial treatment period with Avelox® plus optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician documented data at any initial visit (baseline) and at least one short-term follow-up visit (=initial treatment period).Optionally, long-term follow-ups (6 and 12 months) were documented, and a patient questionnaire was filled in.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a diagnosis of AECB who take moxifloxacin

Description

Inclusion Criteria:

  • Outpatients with diagnosis of AECB and decision taken by the investigator to prescribe moxifloxacin

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the local product information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Moxifloxacin (Avelox, BAY12-8039)
AECB patients under daily life treatment receiving moxifloxacin according to the local product information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of impact of AECB on the patient and the community as well as effect and safety of a treatment with moxifloxacin tablets in daily life clinical practice
Time Frame: During documentation at baseline and at at least one short-term follow-up visit; at maximum two short-term (within ca. 14 days) and two long-term follow-up visits (after ca. 6 and 12 months).
During documentation at baseline and at at least one short-term follow-up visit; at maximum two short-term (within ca. 14 days) and two long-term follow-up visits (after ca. 6 and 12 months).

Secondary Outcome Measures

Outcome Measure
Time Frame
Course of symptom relief
Time Frame: During documentation of up to two short-term follow-up visits (within ca. 14 days)
During documentation of up to two short-term follow-up visits (within ca. 14 days)
Speed of return to normal daily life activities
Time Frame: During documentation of the last short-term follow-up visit (after ca. 14 days)
During documentation of the last short-term follow-up visit (after ca. 14 days)
Adverse events collection
Time Frame: Throughout the entire study, whenever Adverse Events occur
Throughout the entire study, whenever Adverse Events occur
Evaluation of frequency of new exacerbations
Time Frame: During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)
During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)
Progression of chronic respiratory disease
Time Frame: During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)
During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

July 2, 2009

First Submitted That Met QC Criteria

July 2, 2009

First Posted (Estimate)

July 3, 2009

Study Record Updates

Last Update Posted (Estimate)

November 19, 2012

Last Update Submitted That Met QC Criteria

November 16, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12219 (Other Identifier: Company Internal)
  • 12217 (Other Identifier: Company Internal)
  • 12227 (Company Internal)
  • 12220 (Other Identifier: Company Internal)
  • 12224 (Company Internal)
  • 12229 (Company Internal)
  • 12212 (Other Identifier: Company Internal)
  • 12228 (Other Identifier: Company Internal)
  • 12216 (Other Identifier: Company Internal)
  • 12232 (Other Identifier: Company Internal)
  • 12211 (Company Internal)
  • 12214 (Other Identifier: Company Internal)
  • AX0401 (Other Identifier: Company Internal)
  • 11828 (Other Identifier: Company Internal)
  • 12206 (Other Identifier: Company Internal)
  • 12234 (Other Identifier: Company Internal)
  • 12213 (Company Internal)
  • 12225 (Other Identifier: Company Internal)
  • 12223 (Other Identifier: Company Internal)
  • 12221 (Other Identifier: Company Internal)
  • 12218 (Other Identifier: Company Internal)
  • 12222 (Other Identifier: Company Internal)
  • 12230 (Other Identifier: Company Internal)
  • 12226 (Other Identifier: Company Internal)
  • 12235 (Other Identifier: Company Internal)
  • 12233 (Other Identifier: Company Internal)
  • 12215 (Other Identifier: Company Internal)
  • 12231 (Other Identifier: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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