Treatment of Patients With Acute Sinusitis

Acute Bacterial Sinusitis Clinical Trial

Official title:

Treatment of Patients With Acute Sinusitis in Daily Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930488
• Other study ID #: 12803
• Secondary ID: TOPASAX 06011286
• Status: Completed
• Phase: N/A
• First received: June 29, 2009
• Last updated: November 19, 2012
• Start date: March 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Ministry of HealthPakistan: Ministry of HealthPakistan: Research Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)Singapore: Domain Specific Review BoardsSingapore: Health Sciences AuthorityIndonesia: National Agency of Drug and Food ControlPhilippines: Department of HealthChina: Ethics CommitteeChina: Ministry of HealthChina: National Natural Science FoundationChina: Food and Drug AdministrationRomania: Ethics CommitteeMalaysia: Ministry of HealthFrance: French Data Protection AuthorityJordan: Ethical CommitteeLebanon: Institutional Review BoardLebanon: Ministry of Public HealthSaudi Arabia: Ministry of HealthSaudi Arabia: Research Advisory Council
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6777
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Bacterial Sinusitis
• Sinusitis

Intervention

Drug:
• Avelox (Moxifloxacin, BAY12-8039)
Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Bahrain,  China,  Egypt,  France,  Germany,  Indonesia,  Jordan,  Kuwait,  Lebanon,  Malaysia,  Netherlands,  Pakistan,  Philippines,  Romania,  Saudi Arabia,  Singapore,  United Arab Emirates,  Yemen, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		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).	No
Secondary	Evaluation of tolerability and safety of Avalox® in daily practice were investigated.		Evaluation of therapy outcome at last follow-up visit at end of therapy (approximately after 7 days).	Yes
Secondary	Patient characteristics in acute bacterial sinusitis		Documentation at baseline visit.	No
Secondary	History and frequency of sinusitis episodes		Documentation at baseline visit.	No
Secondary	Diagnostic procedures and therapeutic options chosen by physicians in daily practice		Documentation at baseline visit.	No

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