Skin Diseases, BacterialARTOSNCT00997997
Avelox in Complicated Skin and Skin Structure Infections
An observational study of Skin Diseases, Bacterial, run by Bayer at 12 sites in 12 countries.
Trial summary
This international, prospective, non-interventional, non-controlled observational study obtains data on efficacy, safety and tolerability of Avelox treatment under daily-life treatment conditions. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Skin Diseases, Bacterial
- What is being tested?
- Moxifloxacin (Avelox, BAY12-8039)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 6,127 participants
- Where
- 12 sitesin 12 countries
- Study dates
- Oct 2005to 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients being diagnosed with complicated skin and skin structure infections, mainly in hospital settings
Who may be able to join
- Any patient with a diagnosis of complicated skin and skin structure infection (cSSSI) and for whom the decision was made by the attending physician to start treatment with Avelox before inclusion into and independent of the study.
Who cannot join
- Exclusion criteria are those specified in the local product information.
Trial locations and contacts
12 sites in 12 countries.
12 sites in 12 countries
About this study
Official title: ARTOS - Avelox® in Routine Treatment of Complicated Skin and Skin Structure Infections
This international, prospective, non-interventional, non-controlled observational study obtains data on efficacy, safety and tolerability of Avelox treatment under daily-life treatment conditions. Specifically investigated are the improvement of clinical symptoms and the duration until infection improvement and cure.Any patient with a diagnosis of complicated skin and skin structure infection (cSSSI) treated with Avelox can be documented. The observation period for each subject covers the treatment period with Avelox. For each patient, the physician documents data at an initial visit and one or two follow-up visit(s) in line with routine practice.
- Conditions
- Skin Diseases, Bacterial
- Being tested
- Moxifloxacin (Avelox, BAY12-8039)
- Keywords
- Skin Diseases, Bacterial, Product Surveillance, Postmarketing
- Medical subject headings
- Skin Diseases, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin (Avelox, BAY12-8039)Drug
400 mg, intravenous / oral, once daily, treatment duration at the discretion of the attending physician who must consult the local product information
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Moxifloxacin (Avelox, BAY12-8039) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: course of severity of infection, course of clinical signs and symptoms, duration until improvement, duration until recovery, duration until wound closure, overall assessment of efficacy by the physician, reuse of Avelox
Measured: last documented follow-up visit, according to the respective praxis routine
Secondary outcomes (2)
Adverse events collection
Measured: during entire study course, according to the respective praxis routine
Overall assessment of tolerability by the physician
Measured: last documented follow-up visit, according to the respective praxis routine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startOct 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Diseases, BacterialStudies 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
- 6,127 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
- NCT00997997
- Sponsor's protocol ID
- 12237
- Other IDs
- 12236 (AX0502DE), 12237 (AX0502AT), 12519 (AX0502SI), 12645 (AX0502BG), 12646 (AX0502PK), 12754 (AX0502GR), 12865 (AX0502KR), 12866 (AX0502TW)
- Acronym
- ARTOS
- Status last verified
- Nov 2012
- First submitted
- 2 Oct 2009
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARTOS - Avelox® in Routine Treatment of Complicated Skin and Skin Structure Infections
- ClinicalTrials.gov ID
- NCT00997997
- Acronym / sponsor ID
- ARTOS / 12237
- Conditions
- Skin Diseases, Bacterial
- Keywords
- Skin Diseases, Bacterial, Product Surveillance, Postmarketing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,127 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Oct 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.
This international, prospective, non-interventional, non-controlled observational study obtains data on efficacy, safety and tolerability of Avelox treatment under daily-life treatment conditions. Specifically investigated are the improvement of clinical symptoms and the duration until infection improvement and cure.Any patient with a diagnosis of complicated skin and skin structure infection (cSSSI) treated with Avelox can be documented. The observation period for each subject covers the treatment period with Avelox. For each patient, the physician documents data at an initial visit and one or two follow-up visit(s) in line with routine practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Moxifloxacin (Avelox, BAY12-8039) |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients being diagnosed with complicated skin and skin structure infections, mainly in hospital settings
Key inclusion criteria (1 listed)
- Any patient with a diagnosis of complicated skin and skin structure infection (cSSSI) and for whom the decision was made by the attending physician to start treatment with Avelox before inclusion into and independent of the study.
Key exclusion criteria (1 listed)
- Exclusion criteria are those specified in the local product information.
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 |
|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039)400 mg, intravenous / oral, once daily, treatment duration at the discretion of the attending physician who must consult the local product information | Drug | Group 1 |
Primary outcome
Efficacy: course of severity of infection, course of clinical signs and symptoms, duration until improvement, duration until recovery, duration until wound closure, overall assessment of efficacy by the physician, reuse of Avelox
Time frame: last documented follow-up visit, according to the respective praxis routine
2 secondary outcomes
Adverse events collection
Time frame: during entire study course, according to the respective praxis routine
Overall assessment of tolerability by the physician
Time frame: last documented follow-up visit, according to the respective praxis routine
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 16 Nov 2012.
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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
12 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Diseases, Bacterial, run by Bayer at 12 sites in 12 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 16 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 12 sites in Austria, Bulgaria, Egypt, Germany, Greece and 7 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?
Efficacy: course of severity of infection, course of clinical signs and symptoms, duration until improvement, duration until recovery, duration until wound closure, overall assessment of efficacy by the physician, reuse of Avelox (time frame: last documented follow-up visit, according to the respective praxis routine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2012.