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Treatment of Patients With Acute Sinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00930488
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : November 20, 2012
Sponsor:
Information provided by:
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment
Acute Bacterial Sinusitis Drug: Avelox (Moxifloxacin, BAY12-8039)

Study Type : Observational
Actual Enrollment : 6777 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Patients With Acute Sinusitis in Daily Practice
Study Start Date : March 2007
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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). ]

Secondary Outcome Measures :
  1. 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). ]
  2. Patient characteristics in acute bacterial sinusitis [ Time Frame: Documentation at baseline visit. ]
  3. History and frequency of sinusitis episodes [ Time Frame: Documentation at baseline visit. ]
  4. Diagnostic procedures and therapeutic options chosen by physicians in daily practice [ Time Frame: Documentation at baseline visit. ]

Biospecimen Retention:   None Retained
n.a.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930488


  Show 19 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00930488     History of Changes
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 )
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: November 20, 2012
Last Verified: November 2012

Keywords provided by Bayer:
Moxifloxacin
MXF
Avelox
Sinusitis
Acute bacterial sinusitis, ABS

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
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
Nucleic Acid Synthesis Inhibitors