Clinical trial NCT00930488: Treatment of Patients With Acute Sinusitis
Official title: Treatment of Patients With Acute Sinusitis in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Bacterial Sinusitis
Keywords: Moxifloxacin
MXF
Avelox
Sinusitis
Acute bacterial sinusitis, ABS
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-06-30
Enrollment: 6777
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 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:
measure: Evaluation of tolerability and safety of Avalox® in daily practice were investigated.
timeFrame: Evaluation of therapy outcome at last follow-up visit at end of therapy (approximately after 7 days).
measure: Patient characteristics in acute bacterial sinusitis
timeFrame: Documentation at baseline visit.
measure: History and frequency of sinusitis episodes
timeFrame: Documentation at baseline visit.
measure: Diagnostic procedures and therapeutic options chosen by physicians in daily practice
timeFrame: Documentation at baseline visit.
Other outcomes:
Locations:
city: Many Locations
country: Austria
city: Many Locations
country: Bahrain
city: Many Locations
country: China
city: Many Locations
country: Egypt
city: Many Locations
country: France
city: Many Locations
country: Germany
city: Many Locations
country: Indonesia
city: Many Locations
country: Jordan
city: Many Locations
country: Kuwait
city: Many Locations
country: Lebanon
city: Many Locations
country: Malaysia
city: Many Locations
country: Netherlands
city: Many Locations
country: Pakistan
city: Many Locations
country: Philippines
city: Many Locations
country: Romania
city: Many Locations
country: Saudi Arabia
city: Many Locations
country: Singapore
city: Many Locations
country: United Arab Emirates
city: Many Locations
country: Yemen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.