Maxillary SinusitisPhase 4SPEEDNCT00668304
Trial to Evaluate Time to Symptom Relief and Elimination of Infecting Bacteria in Treating Sinusitis With Avelox
A Phase 4 study testing Avelox (Moxifloxacin, BAY12-8039) in people with Maxillary Sinusitis, run by Bayer at 35 sites in 2 countries.
Trial summary
This study evaluated the time to bacteriological eradication of common pathogens during moxifloxacin therapy for acute bacterial maxillary sinusitis. The study also examined the time to resolution of key symptoms associated with sinusitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillary Sinusitis
- What is being tested?
- Avelox (Moxifloxacin, BAY12-8039)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 35 sitesin 2 countries
- Study dates
- Jun 2004to Jan 2005
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute sinusitis with signs and symptoms present for >7 days but < 28 days as defined by A), radiographic, and B) clinical criteria, as follows:a. The presence of 1 or more of the following on a radiographic paranasal sinus film (Waters' view) or limited CT scan: evidence of air-fluid levels opacification. The presence of at least one major and one minor symptom as defined in the list below: Major Symptoms* Purulent anterior or posterior nasal discharge* Unilateral moderate or severe facial pain or malar tenderness Minor Symptoms* Cough or frequent throat clearing* Frontal headache* Halitosis* Fever (oral > 38.0°C/100.4°F, tympanic > 38.5°C/101.2°F)*** Purulent secretions obtained via middle meatus secretion sampling using nasal endoscopic technique; the specimen sent for Gram stain, culture and susceptibility testing prior to initiation of antimicrobial therapy
Who cannot join
- History of chronic sinusitis defined as greater than four weeks of continuous symptoms (patients with history of sinus surgery may be included; patients with recurrent sinusitis may be included)
- Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses- Received systemic antibacterial therapy likely to be effective in sinusitis for more than 24 hours within 7 days of enrollment- A requirement for concomitant systemic antibacterial therapy with agents other than those specified in this protocol- Known immunodeficiency diseases including AIDS (CD4 <200)- On topical nasal or systemic corticosteroids, unless they have been on a stable dose for > 4 weeks prior to enrollment- History of allergy to quinolone antibiotics or related compounds- Pregnant or breast feeding- Of childbearing potential in whom pregnancy cannot be excluded by a negative pregnancy test and who are not using reliable barrier method of contraception
- Received an investigational drug in the past 30 days- Unable to take oral medication- Known to have congenital or sporadic syndromes of QTc prolongation or receiving concomitant medication reported to increase the QTc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine)
- End stage liver cirrhosis (class Child-Pugh C)- Severe renal impairment requiring dialysis
- Previous history of tendinopathy associated with quinolones- Any symptoms that suggest that the patient's current illness is allergic rhinitis (e.g., repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
- Diagnosis of rapidly fatal illness with a life expectance of less than 6 months- Previously enrolled in this clinical study- Uncorrected hypokalaemia
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States29 sites
Study site
Birmingham, Alabama, 35206
Study site
Bridgeport, Connecticut, 06606
Study site
Carrollton, Texas, 75010
Study site
Charlottesville, Virginia, 22902
Study site
Colorado Springs, Colorado, 80909
Study site
Columbus, Ohio, 43235
Study site
DeLand, Florida, 32720-2560
Study site
Detroit, Michigan, 48202
Study site
Fresno, California, 93720
Study site
Greenville, South Carolina, 29607
Study site
Harrisburg, Pennsylvania, 17110
Study site
Hoover, Alabama, 35216-5453
Study site
Jackson, Tennessee, 38301
Study site
Jonesboro, Arkansas, 72401
Study site
Lake Oswego, Oregon, 97035
Study site
Longmont, Colorado, 80501
Study site
North Massapequa, New York, 11758
Study site
Oklahoma City, Oklahoma, 73120
Study site
Orangeburg, South Carolina, 29118
Study site
Richmond, Virginia, 23229
Study site
Riverside, California, 92506
Study site
Rochester, New York, 14618
Study site
Salt Lake City, Utah, 84102
Study site
San Francisco, California, 94102
Study site
Searcy, Arkansas, 72143
Study site
Shreveport, Louisiana, 71105
Study site
Spokane, Washington, 99202-1334
Study site
Winchester, Virginia, 22601
Study site
Yukon, Oklahoma, 73099
Argentina6 sites
Study site
Buenos Aires, Buenos Aires F.D., 1416
Study site
Buenos Aires, Buenos Aires F.D., C1280AEB
Study site
Córdoba, Córdoba Province, 5000
Study site
Rosario, Santa Fe Province, 2000
Study site
San Juan Bautista, Buenos Aires, 1888
Study site
San Miguel de Tucumán, Tucumán Province, 4000
About this study
Official title: Prospective, Multicenter, Open, Uncontrolled Trial to Evaluate the Time to Bacterial Eradication and Key Symptom Relief in the Treatment of Acute Bacterial Maxillary Sinusitis With Moxifloxacin 400 mg QD
This study evaluated the time to bacteriological eradication of common pathogens during moxifloxacin therapy for acute bacterial maxillary sinusitis. The study also examined the time to resolution of key symptoms associated with sinusitis.
- Conditions
- Maxillary Sinusitis
- Being tested
- Avelox (Moxifloxacin, BAY12-8039)
- Keywords
- Sinusitis
- Medical subject headings
- Maxillary Sinusitis, 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
Moxifloxacin 400 mg once orally daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 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.
Time to bacteriological eradication in those who are microbiologically valid for S. pneumoniae, M. catarrhalis, and H. influenzae
Measured: Days 1, 2, 3 of treatment
Secondary outcomes (6)
Patient-reported symptom improvement using SNOT-16 questionnaire
Measured: Up to End of Treatment (Day 10-13)
Clinical Response
Measured: End of Treatment
Bacteriological Response
Measured: End of Treatment
Activity Impairment Assessment questionnaire
Measured: Up to End of Treatment (Day 10-13)
Incidence of Premature Termination
Measured: Premature Termination
Adverse Events Collection
Measured: Up to End of Treatment (Day 10-13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startJun 2004
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668304
- Sponsor's protocol ID
- 100569
- Acronym
- SPEED
- Status last verified
- Dec 2014
- First submitted
- 25 Apr 2008
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Open, Uncontrolled Trial to Evaluate the Time to Bacterial Eradication and Key Symptom Relief in the Treatment of Acute Bacterial Maxillary Sinusitis With Moxifloxacin 400 mg QD
- ClinicalTrials.gov ID
- NCT00668304
- Acronym / sponsor ID
- SPEED / 100569
- Conditions
- Maxillary Sinusitis
- Keywords
- Sinusitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Jan 2005 (actual)
- First posted
- 29 Apr 2008 (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 study evaluated the time to bacteriological eradication of common pathogens during moxifloxacin therapy for acute bacterial maxillary sinusitis. The study also examined the time to resolution of key symptoms associated with sinusitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Avelox (Moxifloxacin, BAY12-8039) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of acute sinusitis with signs and symptoms present for >7 days but < 28 days as defined by A), radiographic, and B) clinical criteria, as follows:a. The presence of 1 or more of the following on a radiographic paranasal sinus film (Waters' view) or limited CT scan: evidence of air-fluid levels opacification. The presence of at least one major and one minor symptom as defined in the list below: Major Symptoms* Purulent anterior or posterior nasal discharge* Unilateral moderate or severe facial pain or malar tenderness Minor Symptoms* Cough or frequent throat clearing* Frontal headache* Halitosis* Fever (oral > 38.0°C/100.4°F, tympanic > 38.5°C/101.2°F)*** Purulent secretions obtained via middle meatus secretion sampling using nasal endoscopic technique; the specimen sent for Gram stain, culture and susceptibility testing prior to initiation of antimicrobial therapy
Key exclusion criteria (6 listed)
- History of chronic sinusitis defined as greater than four weeks of continuous symptoms (patients with history of sinus surgery may be included; patients with recurrent sinusitis may be included)
- Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses- Received systemic antibacterial therapy likely to be effective in sinusitis for more than 24 hours within 7 days of enrollment- A requirement for concomitant systemic antibacterial therapy with agents other than those specified in this protocol- Known immunodeficiency diseases including AIDS (CD4 <200)- On topical nasal or systemic corticosteroids, unless they have been on a stable dose for > 4 weeks prior to enrollment- History of allergy to quinolone antibiotics or related compounds- Pregnant or breast feeding- Of childbearing potential in whom pregnancy cannot be excluded by a negative pregnancy test and who are not using reliable barrier method of contraception
- Received an investigational drug in the past 30 days- Unable to take oral medication- Known to have congenital or sporadic syndromes of QTc prolongation or receiving concomitant medication reported to increase the QTc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine)
- End stage liver cirrhosis (class Child-Pugh C)- Severe renal impairment requiring dialysis
- Previous history of tendinopathy associated with quinolones- Any symptoms that suggest that the patient's current illness is allergic rhinitis (e.g., repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
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)Moxifloxacin 400 mg once orally daily | Drug | Arm 1 |
Primary outcome
Time to bacteriological eradication in those who are microbiologically valid for S. pneumoniae, M. catarrhalis, and H. influenzae
Time frame: Days 1, 2, 3 of treatment
6 secondary outcomes
Patient-reported symptom improvement using SNOT-16 questionnaire
Time frame: Up to End of Treatment (Day 10-13)
Clinical Response
Time frame: End of Treatment
Bacteriological Response
Time frame: End of Treatment
Activity Impairment Assessment questionnaire
Time frame: Up to End of Treatment (Day 10-13)
Incidence of Premature Termination
Time frame: Premature Termination
Adverse Events Collection
Time frame: Up to End of Treatment (Day 10-13)
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 19 Dec 2014.
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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
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Avelox (Moxifloxacin, BAY12-8039) in people with Maxillary Sinusitis, run by Bayer at 35 sites in 2 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 6 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 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Argentina. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to bacteriological eradication in those who are microbiologically valid for S. pneumoniae, M. catarrhalis, and H. influenzae (time frame: Days 1, 2, 3 of treatment). 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 19 Dec 2014.