Acute Bacterial SinusitisPhase 4NCT00645073
Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis
A Phase 4 study testing cefdinir (Omnicef) and levofloxacin in people with Acute Bacterial Sinusitis, run by Abbott at 33 sites in 2 countries.
Trial summary
To compare the safety and efficacy of a ten-day course of therapy of cefdinir, 600 mg QD, to a ten-day course of therapy of levofloxacin, 500 mg QD, in the treatment of acute bacterial sinusitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Bacterial Sinusitis
- What is being tested?
- cefdinir (Omnicef) and levofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 33 sitesin 2 countries
- Study dates
- Nov 2003to Mar 2004
- 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
- A female must be non-lactating, non-breastfeeding and at no risk for pregnancy.
- A condition of general good health, based upon the results of a medical history, physical examination, and laboratory profile.
- Subject must have a diagnosis of acute bacterial sinusitis. The diagnosis must be based on the following:
- a sinus radiograph or CT scan performed within 48 hours pre-treatment
- with evidence of maxillary opacification or air/fluid levels
- Purulent discharge from the nose
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- At least one of the following clinical signs and symptoms of acute bacterial sinusitis
- Lasting for more than 7 days prior to and no longer than 21 days before Evaluation 1: facial pain over the sinus or facial pressure over the sinus or facial tightness over the sinus or facial swelling or toothache.
- Subject must be a suitable candidate for oral antimicrobial therapy and is able to swallow capsules intact.
Who cannot join
- Subjects who have: chronic sinusitis (signs and symptoms lasting greater than 28 days prior to Evaluation 1)
- Significant anatomical abnormalities of the sinuses
- Any other infection or condition which necessitates use of a concomitant systemic antimicrobial.
- History of any hypersensitivity or allergic reactions to penicillins, cephalosporins (including cefdinir), or quinolones (including levofloxacin).
- Subject who has taken: a systemic antibiotic within 14 days before study drug administration; a long acting injectable antibiotic (e.g., penicillin G benzathine) within 30 days before study drug administration.
- Known significant renal or hepatic impairment.
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- Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological or endocrine disease, malignancy, or other abnormality (other than the disease being studied).
- Investigator considers the subject unsuitable for cefdinir or levofloxacin therapy, for any reason.
- Previous enrollment in this study.
- Any underlying condition or disease state that would interfere with the completion of the study procedures and evaluations or absorption of study drug.
- Subject who is currently receiving or who is likely to require any of the following medications during the period between Evaluation 1 (initial presentation to office/clinic) and Evaluation 3 (or within 48 hours after the last dose of study drug): Concomitant theophylline or any theophylline analog, unless plasma levels of these drugs can be adequately monitored during the study; Warfarin and probenecid.
- Immunocompromised subjects.
- Subject who requires parenteral antibiotic therapy for this infection or who has any other infection or condition, that necessitates use of a concomitant systemic antibiotic.
- Subjects receiving antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc within 2 hours before or after dosing with study drug.
- Subjects with a known or suspected central nervous system disorder that may predispose the subject to seizures or lower the seizure threshold.
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United States23 sites
Study site
Birmingham, Alabama, 35211
Study site
Birmingham, Alabama, 35215
Study site
Columbiana, Alabama, 35051
Study site
Corsicana, Texas, 75110
Study site
Eclectic, Alabama, 36024
Study site
Eugene, Oregon, 97404
Study site
Fresno, California, 93703
Study site
Fresno, California, 93710
Study site
Kingsport, Tennessee, 37660
Study site
Lake Oswego, Oregon, 97035
Study site
Mesa, Arizona, 85201
Study site
Milan, Tennessee, 38358
Study site
Murray, Kentucky, 42071
Study site
Orangeburg, South Carolina, 29118
Study site
Portage, Michigan, 49024
Study site
Salt Lake City, Utah, 84109
Study site
Salt Lake City, Utah, 84121
Study site
San Antonio, Texas, 78205
Study site
Spokane, Washington, 99204
Study site
Tuscaloosa, Alabama, 35406
Study site
West Jordan, Utah, 84084
Study site
West Jordan, Utah, 84088
Study site
Winchester, Virginia, 22601
Poland10 sites
Study site
Gorzów Wielkopolski, 66-400
Study site
Krakow, 30-510
Study site
Krakow, 31-513
Study site
Lodz, 90-430
Study site
Lodz, 92-215
Study site
Przybysławice, 322-088
Study site
Skierniewice, 96-100
Study site
Szczecin, 70-344
Study site
Szczecin, 70-506
Study site
Szczecin, 71-667
About this study
Official title: A Phase IV Comparative Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis
To compare the safety and efficacy of a ten-day course of therapy of cefdinir, 600 mg QD, to a ten-day course of therapy of levofloxacin, 500 mg QD, in the treatment of acute bacterial sinusitis.
- Conditions
- Acute Bacterial Sinusitis
- Being tested
- cefdinir (Omnicef), levofloxacin
- Keywords
- Acute Bacterial Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefdinir (Omnicef)Drug
Also called ABT-198, Omnicef, cefdinir
Two 300 mg cefdinir capsules on Study Days 1-10.
levofloxacinDrug
Two 250 mg levofloxacin capsules on Study Days 1-10
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: cefdinir (Omnicef) |
| B | Active comparator | Not described Receives: Drug: levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate
Measured: 26 days
Secondary outcomes (2)
Radiographic response
Measured: 26 days
Changes from baseline in clinical signs and symptoms
Measured: 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startNov 2003
- Primary completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Bacterial SinusitisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645073
- Sponsor's protocol ID
- M03-628
- Status last verified
- Mar 2008
- First submitted
- 22 Mar 2008
- Last updated
- 27 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Comparative Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis
- ClinicalTrials.gov ID
- NCT00645073
- Acronym / sponsor ID
- M03-628
- Conditions
- Acute Bacterial Sinusitis
- Keywords
- Acute Bacterial Sinusitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Mar 2004 (actual)
- First posted
- 27 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.
To compare the safety and efficacy of a ten-day course of therapy of cefdinir, 600 mg QD, to a ten-day course of therapy of levofloxacin, 500 mg QD, in the treatment of acute bacterial sinusitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: cefdinir (Omnicef) |
| B | Active comparator | Drug: levofloxacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A female must be non-lactating, non-breastfeeding and at no risk for pregnancy.
- A condition of general good health, based upon the results of a medical history, physical examination, and laboratory profile.
- Subject must have a diagnosis of acute bacterial sinusitis. The diagnosis must be based on the following:
- Purulent discharge from the nose
- At least one of the following clinical signs and symptoms of acute bacterial sinusitis
Key exclusion criteria (15 listed)
- Subjects who have: chronic sinusitis (signs and symptoms lasting greater than 28 days prior to Evaluation 1)
- Significant anatomical abnormalities of the sinuses
- Any other infection or condition which necessitates use of a concomitant systemic antimicrobial.
- History of any hypersensitivity or allergic reactions to penicillins, cephalosporins (including cefdinir), or quinolones (including levofloxacin).
- Subject who has taken: a systemic antibiotic within 14 days before study drug administration; a long acting injectable antibiotic (e.g., penicillin G benzathine) within 30 days before study drug administration.
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 |
|---|---|---|
| cefdinir (Omnicef)Also: ABT-198, Omnicef, cefdinirTwo 300 mg cefdinir capsules on Study Days 1-10. | Drug | A |
| levofloxacinTwo 250 mg levofloxacin capsules on Study Days 1-10 | Drug | B |
Primary outcome
Clinical cure rate
Time frame: 26 days
2 secondary outcomes
Radiographic response
Time frame: 26 days
Changes from baseline in clinical signs and symptoms
Time frame: 26 days
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 27 Mar 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
33 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 cefdinir (Omnicef) and levofloxacin in people with Acute Bacterial Sinusitis, run by Abbott at 33 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 9 inclusion and 15 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 27 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Poland. 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?
Clinical cure rate (time frame: 26 days). 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 27 Mar 2008.