Acute Bacterial SinusitisNCT00930488
Treatment of Patients With Acute Sinusitis
An observational study of Acute Bacterial Sinusitis, run by Bayer at 19 sites in 19 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Bacterial Sinusitis
- What is being tested?
- Avelox (Moxifloxacin, BAY12-8039)
- How many people
- 6,777 participants
- Where
- 19 sitesin 19 countries
- Study dates
- Mar 2007to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin
Who may be able to join
- Any patient with a diagnosis of acute bacterial sinusitis treated with Avelox® - in accordance with the local production information.
Who cannot join
- Those specified in the local product information - contraindications and precautions must be considered.
Trial locations and contacts
19 sites in 19 countries.
19 sites in 19 countries
About this study
Official title: Treatment of Patients With Acute Sinusitis in Daily Practice
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.
- Conditions
- Acute Bacterial Sinusitis
- Being tested
- Avelox (Moxifloxacin, BAY12-8039)
- Keywords
- Moxifloxacin, MXF, Avelox, Sinusitis, Acute bacterial sinusitis, ABS
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avelox (Moxifloxacin, BAY12-8039)Drug
Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Avelox (Moxifloxacin, BAY12-8039) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Evaluation of therapy outcome at last follow-up visit at end of therapy (approximately after 7 days).
Patient characteristics in acute bacterial sinusitis
Measured: Documentation at baseline visit.
History and frequency of sinusitis episodes
Measured: Documentation at baseline visit.
Diagnostic procedures and therapeutic options chosen by physicians in daily practice
Measured: Documentation at baseline visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startMar 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Bacterial SinusitisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,777 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930488
- Sponsor's protocol ID
- 12803
- Other IDs
- TOPAS, AX 0601, 12867 - AX0601AT, 12868 - AX0601PK, 12869 - AX0601EG, 12870 - AX0601NL, 12973 - AX0601SK, 12974 - AX0601SG
- Status last verified
- Nov 2012
- First submitted
- 29 Jun 2009
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Acute Sinusitis in Daily Practice
- ClinicalTrials.gov ID
- NCT00930488
- Acronym / sponsor ID
- 12803
- Conditions
- Acute Bacterial Sinusitis
- Keywords
- Moxifloxacin, MXF, Avelox, Sinusitis, Acute bacterial sinusitis, ABS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,777 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Avelox (Moxifloxacin, BAY12-8039) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin
Key inclusion criteria (1 listed)
- Any patient with a diagnosis of acute bacterial sinusitis treated with Avelox® - in accordance with the local production information.
Key exclusion criteria (1 listed)
- Those specified in the local product information - contraindications and precautions must be considered.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avelox (Moxifloxacin, BAY12-8039)Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin | Drug | Group 1 |
Primary outcome
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).
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
- Derived from this study: PubMed 23626752Mosges 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
19 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Bacterial Sinusitis, run by Bayer at 19 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Austria, Bahrain, China, Egypt, France and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00930488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.