Treatment of Patients With Acute Sinusitis

November 19, 2012 updated by: Bayer

Treatment of Patients With Acute Sinusitis in Daily Practice

For each patient, an initial visit and at least one follow-up visit at the end of treatment should be documented by the treating physician in the case report form.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6777

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

  • 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 acute bacterial sinusitis who take moxifloxacin

Description

Inclusion Criteria:

  • Any patient with a diagnosis of acute bacterial sinusitis treated with Avelox® - in accordance with the local production information.

Exclusion Criteria:

  • Those specified in the local product information - contraindications and precautions must be considered.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Avelox (Moxifloxacin, BAY12-8039)
Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of potential benefits of an antibacterial therapy with Avelox® (moxifloxacin) in patients with acute bacterial sinusitis to whom this treatment was prescribed. Especially the time to improvement and resolution of clinical signs and symptoms of
Time Frame: Documentation at baseline and at at least one follow-up visit. Evaluation of therapy outcome at last follow-up visit at end of therapy (approximately after 7 days).
Documentation at baseline and at at least one follow-up visit. Evaluation of therapy outcome at last follow-up visit at end of therapy (approximately after 7 days).

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of tolerability and safety of Avalox® in daily practice were investigated.
Time Frame: Evaluation of therapy outcome at last follow-up visit at end of therapy (approximately after 7 days).
Evaluation of therapy outcome at last follow-up visit at end of therapy (approximately after 7 days).
Patient characteristics in acute bacterial sinusitis
Time Frame: Documentation at baseline visit.
Documentation at baseline visit.
History and frequency of sinusitis episodes
Time Frame: Documentation at baseline visit.
Documentation at baseline visit.
Diagnostic procedures and therapeutic options chosen by physicians in daily practice
Time Frame: Documentation at baseline visit.
Documentation at baseline visit.

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

March 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

June 29, 2009

First Posted (Estimate)

June 30, 2009

Study Record Updates

Last Update Posted (Estimate)

November 20, 2012

Last Update Submitted That Met QC Criteria

November 19, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12803
  • TOPAS (Other Identifier: Company Internal)
  • AX 0601 (Other Identifier: Company Internal)
  • 12867 - AX0601AT (Other Identifier: Company Internal)
  • 12868 - AX0601PK (Other Identifier: Company Internal)
  • 12869 - AX0601EG (Other Identifier: Company Internal)
  • 12870 - AX0601NL (Other Identifier: Company Internal)
  • 12973 - AX0601SK (Other Identifier: Company Internal)
  • 12974 - AX0601SG (Other Identifier: Company Internal)
  • 13026 - AX0601ID (Other Identifier: Company Internal)
  • 13046 - AX0601PH (Other Identifier: Company Internal)
  • 13111 - AX0601RO (Other Identifier: Company Internal)
  • 13065 - AX0601CN (Other Identifier: Company Internal)
  • 13207 - AX0601FR (Other Identifier: Company Internal)
  • 13166 - AX0601MY (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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