NCT00930488

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,777

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2007

Geographic Reach
19 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
Last Updated

November 20, 2012

Status Verified

November 1, 2012

Enrollment Period

1.8 years

First QC Date

June 29, 2009

Last Update Submit

November 19, 2012

Conditions

Acute Bacterial Sinusitis

Keywords

MoxifloxacinMXFAveloxSinusitisAcute bacterial sinusitis, ABS

Outcome Measures

Primary Outcomes (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

    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 Outcomes (4)

  • 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).

  • Patient characteristics in acute bacterial sinusitis

    Documentation at baseline visit.

  • History and frequency of sinusitis episodes

    Documentation at baseline visit.

  • Diagnostic procedures and therapeutic options chosen by physicians in daily practice

    Documentation at baseline visit.

Study Arms (1)

Group 1

Drug: Avelox (Moxifloxacin, BAY12-8039)

Interventions

Avelox (Moxifloxacin, BAY12-8039)DRUG

Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin

Group 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Unknown Facility

Many Locations, Austria

Location

Unknown Facility

Many Locations, Bahrain

Location

Unknown Facility

Many Locations, China

Location

Unknown Facility

Many Locations, Egypt

Location

Unknown Facility

Many Locations, France

Location

Unknown Facility

Many Locations, Germany

Location

Unknown Facility

Many Locations, Indonesia

Location

Unknown Facility

Many Locations, Jordan

Location

Unknown Facility

Many Locations, Kuwait

Location

Unknown Facility

Many Locations, Lebanon

Location

Unknown Facility

Many Locations, Malaysia

Location

Unknown Facility

Many Locations, Netherlands

Location

Unknown Facility

Many Locations, Pakistan

Location

Unknown Facility

Many Locations, Philippines

Location

Unknown Facility

Many Locations, Romania

Location

Unknown Facility

Many Locations, Saudi Arabia

Location

Unknown Facility

Many Locations, Singapore

Location

Unknown Facility

Many Locations, United Arab Emirates

Location

Unknown Facility

Many Locations, Yemen

Location

Related Publications (1)

  • Mosges R, Desrosiers M, Arvis P, Heldner S. Characterisation of patients receiving moxifloxacin for acute bacterial rhinosinusitis in clinical practice: results from an international, observational cohort study. PLoS One. 2013 Apr 23;8(4):e61927. doi: 10.1371/journal.pone.0061927. Print 2013.

    PMID: 23626752DERIVED

MeSH Terms

Conditions

Sinusitis

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 29, 2009

First Posted

June 30, 2009

Study Start

March 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

November 20, 2012

Record last verified: 2012-11

Locations

DE(1)ID(1)AU(1)JO(1)KU(1)SG(1)PA(1)YE(1)NL(1)SA(1)PH(1)CN(1)AE(1)FR(1)BA(1)LE(1)RO(1)EG(1)MY(1)