This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Treatment of Patients With Acute Sinusitis

This study has been completed.
Information provided by:
Bayer Identifier:
First received: June 29, 2009
Last updated: November 19, 2012
Last verified: November 2012
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 Intervention
Acute Bacterial Sinusitis Drug: Avelox (Moxifloxacin, BAY12-8039)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Patients With Acute Sinusitis in Daily Practice

Resource links provided by NLM:

Further study details as provided by Bayer:

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

Biospecimen Retention:   None Retained

Enrollment: 6777
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Avelox (Moxifloxacin, BAY12-8039)
Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin


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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00930488

  Show 19 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer HealthCare AG 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 )
Study First Received: June 29, 2009
Last Updated: November 19, 2012

Keywords provided by Bayer:
Acute bacterial sinusitis, ABS

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
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 processed this record on September 21, 2017