Maxillary SinusitisPhase 3NCT00643409
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults
A Phase 3 study testing azithromycin SR (Zithromax; compound: CP-62,993) and levofloxacin in people with Maxillary Sinusitis, run by Pfizer at 89 sites in 14 countries.
Trial summary
The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both treatments. 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?
- azithromycin SR (Zithromax; compound: CP-62,993) and levofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 541 participants
- Where
- 89 sitesin 14 countries
- Study dates
- Jan 2003to Feb 2004
- Phase
- Phase 3
- 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
- Patients were included if they had a clinical diagnosis of acute bacterial maxillary sinusitis as demonstrated by presence of the cardinal signs and symptoms for a minimum duration of 7 days, a sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis, and 2 or more of following: fever, leukocytosis, frequent coughing, headache, nasal congestion, or post-nasal drainage.
Who cannot join
- Patients were excluded if they were treated with any systemic antibiotic within 7 days prior to enrollment, had symptoms lasting for longer than 28 days, had 4 or more episodes of acute sinusitis within the preceding 12 months, had nasal or sinus surgery within 3 months prior (except for a diagnostic procedure), or complicated or nosocomial sinusitis.
Trial locations and contacts
89 sites in 14 countries.
89 sites in 14 countries
United States59 sites
Pfizer Investigational Site
Alabaster, Alabama, 35007
Pfizer Investigational Site
Amarillo, Texas, 79109
Pfizer Investigational Site
Amarillo, Texas, 79119
Pfizer Investigational Site
Amarillo, Texas, 79124
Pfizer Investigational Site
Birmingham, Alabama, 35205
Pfizer Investigational Site
Birmingham, Alabama, 35211
Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Bridgeport, Connecticut, 06606
Pfizer Investigational Site
Bryan, Texas, 77802
Pfizer Investigational Site
Charlote, North Carolina, 28210
Pfizer Investigational Site
Charlotte, North Carolina, 28210
Pfizer Investigational Site
Cincinnati, Ohio, 45241
Pfizer Investigational Site
Cincinnati, Ohio, 45242
Pfizer Investigational Site
Clovis, California, 93611
Pfizer Investigational Site
Dayton, Ohio, 45402
Pfizer Investigational Site
Dayton, Ohio, 45406
Pfizer Investigational Site
El Paso, Texas, 79902
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Eugene, Oregon, 97404
Pfizer Investigational Site
Fresno, California, 93710
Pfizer Investigational Site
Fresno, California, 93720
Pfizer Investigational Site
Houston, Texas, 77015
Pfizer Investigational Site
Houston, Texas, 77074
Pfizer Investigational Site
Hueytown, Alabama, 35023
Pfizer Investigational Site
Jefferson City, Missouri, 65101
Pfizer Investigational Site
Jonesboro, Arkansas, 72401
Pfizer Investigational Site
Kalamazoo, Michigan, 49008
Pfizer Investigational Site
Louisville, Kentucky, 40207
Pfizer Investigational Site
Medford, Oregon, 97504
Pfizer Investigational Site
Missoula, Montana, 59801
Pfizer Investigational Site
Missoula, Montana, 59804
Pfizer Investigational Site
Montgomery, Alabama, 36106
Pfizer Investigational Site
Montgomery, Alabama, 36109
Pfizer Investigational Site
Morrisville, Pennsylvania, 19067
Pfizer Investigational Site
Murray, Utah, 84107
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New Orleans, Louisiana, 70115
Pfizer Investigational Site
Norristown, Pennsylvania, 19401
Pfizer Investigational Site
Orangeburg, South Carolina, 29118
Pfizer Investigational Site
Pasadena, Texas, 77505
Pfizer Investigational Site
Pelham, Alabama, 35124
Pfizer Investigational Site
Plymouth Meeting, Pennsylvania, 19462
Pfizer Investigational Site
Portage, Michigan, 49024
Pfizer Investigational Site
Richland, Michigan, 49083
Pfizer Investigational Site
Salt Lake City, Utah, 84102
Pfizer Investigational Site
Salt Lake City, Utah, 84109
Pfizer Investigational Site
Salt Lake City, Utah, 84121
Pfizer Investigational Site
San Antonio, Texas, 78205
Pfizer Investigational Site
San Antonio, Texas, 78224
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Diego, California, 92117
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
Three Rivers, Michigan, 49093
Pfizer Investigational Site
Tuscaloosa, Alabama, 35404
Pfizer Investigational Site
Tuscaloosa, Alabama, 35406
Pfizer Investigational Site
Wichita, Kansas, 67208
Pfizer Investigational Site
Wichita Falls, Texas, 76302
Pfizer Investigational Site
Wichita Falls, Texas, 76309
Costa Rica5 sites
Pfizer Investigational Site
Bo. Aranjuez, Provincia de San José
Pfizer Investigational Site
Escazú, Provincia de San José
Pfizer Investigational Site
Guadalupe, Provincia de San José
Pfizer Investigational Site
San José, Provincia de San José
Pfizer Investigational Site
Uruca, Provincia de San José
Poland4 sites
Pfizer Investigational Site
Bielsko-Biala
Pfizer Investigational Site
Katowice, 40-027
Pfizer Investigational Site
Lublin, 20-718
Pfizer Investigational Site
Poznan, 60-355
Czechia3 sites
Pfizer Investigational Site
Prague, 100 34
Pfizer Investigational Site
Prague, 128 08
Pfizer Investigational Site
Prague, 150 06
India3 sites
Pfizer Investigational Site
Bangalore, Karnataka, 560 034
Pfizer Investigational Site
Kochi, Kerala, 682 026
Pfizer Investigational Site
Lucknow, Uttar Pradesh, 226020
Russia3 sites
Pfizer Investigational Site
Moscow, 117049
Pfizer Investigational Site
Moscow, 125206
Pfizer Investigational Site
Smolensk, 214019
Slovakia3 sites
Pfizer Investigational Site
Bratislava, Slovakia
Pfizer Investigational Site
Košice, Slovakia, 040 11
Pfizer Investigational Site
Martin, Slovakia, 036 01
Estonia2 sites
Pfizer Investigational Site
Tallinn, 13419
Pfizer Investigational Site
Tartu, 51003
Lithuania2 sites
Pfizer Investigational Site
Vilnius, LT-2005
Pfizer Investigational Site
Vilnius, LT-2600
Location not given1 site
Pfizer Investigational Site
About this study
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Bacterial Maxillary Sinusitis in Adults Undergoing Diagnostic Sinus Aspiration
The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both treatments.
- Conditions
- Maxillary Sinusitis
- Being tested
- azithromycin SR (Zithromax; compound: CP-62,993), placebo, levofloxacin
- Medical subject headings
- Maxillary Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycin SR (Zithromax; compound: CP-62,993)Drug
Azithromycin SR 2.0 g by mouth in the form of a slurry x 1 dose
placeboOther
placebo
levofloxacinDrug
levofloxacin 500 mg capsule by mouth qd x 10 days
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: azithromycin SR (Zithromax; compound: CP-62,993); Other: placebo |
| 2 | Experimental | Not described Receives: Drug: levofloxacin; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
sponsor assessment of clinical response for the Clinical per Protocol population
Measured: Test of Cure (TOC) visit (Day 17-24)
Secondary outcomes (8)
sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population
Measured: EOT visit and TOC visit
investigator assessment of clinical response for the Clinical per Protocol population
Measured: TOC visit
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
Measured: TOC visit
summary of baseline susceptibilities
Measured: Study endpoint
adverse events
Measured: Continuous
laboratory abnormalities
Measured: during and post-treatment
sponsor assessment of clinical response for the Clinical per Protocol population
Measured: End of Treatment (EOT) visit (Day 11-13)
sponsor assessment of clinical response for the remaining study populations
Measured: EOT visit and TOC visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startJan 2003
- Study completionFeb 2004
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 PfizerThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643409
- Sponsor's protocol ID
- A0661078
- Status last verified
- May 2011
- First submitted
- 19 Mar 2008
- Last updated
- 11 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Bacterial Maxillary Sinusitis in Adults Undergoing Diagnostic Sinus Aspiration
- ClinicalTrials.gov ID
- NCT00643409
- Acronym / sponsor ID
- A0661078
- Conditions
- Maxillary Sinusitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Feb 2004 (actual)
- First posted
- 26 Mar 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.
The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: azithromycin SR (Zithromax; compound: CP-62,993), Other: placebo |
| 2 | Experimental | Drug: levofloxacin, Other: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients were included if they had a clinical diagnosis of acute bacterial maxillary sinusitis as demonstrated by presence of the cardinal signs and symptoms for a minimum duration of 7 days, a sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis, and 2 or more of following: fever, leukocytosis, frequent coughing, headache, nasal congestion, or post-nasal drainage.
Key exclusion criteria (1 listed)
- Patients were excluded if they were treated with any systemic antibiotic within 7 days prior to enrollment, had symptoms lasting for longer than 28 days, had 4 or more episodes of acute sinusitis within the preceding 12 months, had nasal or sinus surgery within 3 months prior (except for a diagnostic procedure), or complicated or nosocomial 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 |
|---|---|---|
| azithromycin SR (Zithromax; compound: CP-62,993)Azithromycin SR 2.0 g by mouth in the form of a slurry x 1 dose | Drug | 1 |
| placeboplacebo | Other | 1 |
| levofloxacinlevofloxacin 500 mg capsule by mouth qd x 10 days | Drug | 2 |
| placeboplacebo | Other | 2 |
Primary outcome
sponsor assessment of clinical response for the Clinical per Protocol population
Time frame: Test of Cure (TOC) visit (Day 17-24)
8 secondary outcomes
sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population
Time frame: EOT visit and TOC visit
investigator assessment of clinical response for the Clinical per Protocol population
Time frame: TOC visit
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
Time frame: TOC visit
summary of baseline susceptibilities
Time frame: Study endpoint
adverse events
Time frame: Continuous
laboratory abnormalities
Time frame: during and post-treatment
sponsor assessment of clinical response for the Clinical per Protocol population
Time frame: End of Treatment (EOT) visit (Day 11-13)
sponsor assessment of clinical response for the remaining study populations
Time frame: EOT visit and TOC 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 11 May 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
89 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing azithromycin SR (Zithromax; compound: CP-62,993) and levofloxacin in people with Maxillary Sinusitis, run by Pfizer at 89 sites in 14 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 11 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in United States, Costa Rica, Poland, Czechia, India and 8 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
sponsor assessment of clinical response for the Clinical per Protocol population (time frame: Test of Cure (TOC) visit (Day 17-24)). 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 11 May 2011.