CClinicalTrials.gg
CompletedNCT00930488Updated Nov 20, 2012

Treatment of Patients With Acute Sinusitis

An observational study in Acute Bacterial Sinusitis, sponsored by Bayer. Completed at 19 sites in 19 countries. Per ClinicalTrials.gov, last updated 2012-11-20.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,777
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Bacterial Sinusitis

Browse trials for

Keywords

  • Moxifloxacin
  • MXF
  • Avelox
  • Sinusitis
  • Acute bacterial sinusitis, ABS
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

  • Those specified in the local product information - contraindications and precautions must be considered.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6,777 participants (actual)

Groups and cohorts

  • Group 1

    Drug: Avelox (Moxifloxacin, BAY12-8039)

Interventions

  • DrugAvelox (Moxifloxacin, BAY12-8039)

    Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin

05

What researchers measure

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

    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 outcomes

  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.

06

Study locations

19 sites
  • Many Locations, Austria
  • Many Locations, Bahrain
  • Many Locations, China
  • Many Locations, Egypt
  • Many Locations, France
  • Many Locations, Germany
  • Many Locations, Indonesia
  • Many Locations, Jordan
  • Many Locations, Kuwait
  • Many Locations, Lebanon
  • Many Locations, Malaysia
  • Many Locations, Netherlands
  • Many Locations, Pakistan
  • Many Locations, Philippines
  • Many Locations, Romania
  • Many Locations, Saudi Arabia
  • Many Locations, Singapore
  • Many Locations, United Arab Emirates
  • Many Locations, Yemen
07

References and documents

Publications

  • 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. PubMed 23626752 ↗
08

Registry details

Key details

Study ID
NCT00930488
Lead sponsor
Bayer
First posted
Jun 30, 2009
Start date
Mar 2007
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Nov 20, 2012

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion