Maxillary SinusitisPhase 3NCT00236652
A Study Evaluating the Safety and Efficacy of Treating Sinus Infection With Levofloxacin 750 mg for 5 Days.
A Phase 3 study testing levofloxacin in people with Maxillary Sinusitis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of a once-daily administration of 750 milligrams levofloxacin (an antibiotic) for five days, in treating bacterial sinus infections. 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?
- levofloxacin
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Jun 2005
- 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
- Clinical signs and symptoms of acute maxillary sinusitis for 5 to 28 days
- Visible nasal purulence evident on physical examination
- CT scan or standard sinus x-ray (Waters' projections) performed within 5 days prior to the first dose of study drug, showing total sinus opacification or an air-fluid level
- Agree to a maxillary sinus puncture and catheter placement
- If female, using birth control
Who cannot join
- Chronic sinusitis
- Need for hospitalization or intravenous antibiotics
- History of head, neck, or nasal cancer or surgery
- Previous allergy, serious adverse reaction to, or failed therapy with, levofloxacin or any other member of the quinolone class
- Presence or history of serious complications of sinusitis
- Previous antimicrobial therapy within 7 days of Study Entry
About this study
Official title: An Open-label, Multi-center, Non-comparative Sinus Puncture Study of 750 mg, Short-course Levofloxacin in the Treatment of Acute Maxillary Sinusitis
The purpose of this study is to evaluate the effectiveness and safety of a once-daily administration of 750 milligrams levofloxacin (an antibiotic) for five days, in treating bacterial sinus infections.
Read the detailed description
Acute bacterial sinusitis is a common diagnosis for which an antibiotic is prescribed in outpatients. Some types of bacteria that cause sinusitis are resistant to penicillin and certain other classes of antibiotics, but may be treatable with the antibiotic levofloxacin. This will be an open-label, multi-center, non-comparative clinical trial involving outpatients with protocol-defined acute bacterial sinusitis suitable for treatment with oral antibiotics. At the Preliminary Visit, a sinus radiograph will be obtained to confirm the clinical diagnosis of sinusitis, and the Investigator will perform a nasal exam. Sinus puncture and placement of an indwelling sinus catheter into an affected maxillary sinus will be performed on all eligible patients at the first visit. Patients meeting the study criteria will receive 750 milligrams levofloxacin tablets once daily for 5 days. The primary objective is to establish the rate and extent of bacteriological eradication, defined as eradication of pathogens from the maxillary sinus, and to establish the effectiveness and safety of once-daily 750 milligrams levofloxacin for the treatment of acute bacterial sinusitis in adults.
Levofloxacin 750 milligram tablet orally once a day for 5 days
- Conditions
- Maxillary Sinusitis
- Being tested
- levofloxacin
- Keywords
- Maxillary Sinusitis, Infection
- Medical subject headings
- Maxillary Sinusitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levofloxacinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to bacteriological eradication, defined as the complete eradication of original strain(s) from the sinus, by the 5th day of levofloxacin treatment.
Secondary outcomes (1)
Efficacy: Clinical response on Day 5 and at the Post-Therapy Visit (Days 12-19); plasma and sinus aspirate concentrations on Days 2-4; levels of inflammatory mediators on Days 0-5. Safety: Adverse events, vital signs, and clinical laboratory tests.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startNov 2003
- Study completionJun 2005
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 Maxillary 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc.
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236652
- Sponsor's protocol ID
- CR004678
- Status last verified
- Apr 2010
- First submitted
- 7 Oct 2005
- Last updated
- 10 Jun 2011
- Results posted
- No
Publications
Anon JB, Paglia M, Xiang J, Ambrose PG, Jones RN, Kahn JB. Serial sinus aspirate samples during high-dose, short-course levofloxacin treatment of acute maxillary sinusitis. Diagn Microbiol Infect Dis. 2007 Jan;57(1):105-7. doi: 10.1016/j.diagmicrobio.2006.10.019.
PubMed 17178300
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Non-comparative Sinus Puncture Study of 750 mg, Short-course Levofloxacin in the Treatment of Acute Maxillary Sinusitis
- ClinicalTrials.gov ID
- NCT00236652
- Acronym / sponsor ID
- CR004678
- Conditions
- Maxillary Sinusitis
- Keywords
- Maxillary Sinusitis, Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc.
- Study start
- Nov 2003
- Study completion
- Jun 2005 (actual)
- First posted
- 12 Oct 2005 (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 purpose of this study is to evaluate the effectiveness and safety of a once-daily administration of 750 milligrams levofloxacin (an antibiotic) for five days, in treating bacterial sinus infections.
Detailed description
Acute bacterial sinusitis is a common diagnosis for which an antibiotic is prescribed in outpatients. Some types of bacteria that cause sinusitis are resistant to penicillin and certain other classes of antibiotics, but may be treatable with the antibiotic levofloxacin. This will be an open-label, multi-center, non-comparative clinical trial involving outpatients with protocol-defined acute bacterial sinusitis suitable for treatment with oral antibiotics. At the Preliminary Visit, a sinus radiograph will be obtained to confirm the clinical diagnosis of sinusitis, and the Investigator will perform a nasal exam. Sinus puncture and placement of an indwelling sinus catheter into an affected maxillary sinus will be performed on all eligible patients at the first visit. Patients meeting the study criteria will receive 750 milligrams levofloxacin tablets once daily for 5 days. The primary objective is to establish the rate and extent of bacteriological eradication, defined as eradication of pathogens from the maxillary sinus, and to establish the effectiveness and safety of once-daily 750 milligrams levofloxacin for the treatment of acute bacterial sinusitis in adults.
Levofloxacin 750 milligram tablet orally once a day for 5 days
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical signs and symptoms of acute maxillary sinusitis for 5 to 28 days
- Visible nasal purulence evident on physical examination
- CT scan or standard sinus x-ray (Waters' projections) performed within 5 days prior to the first dose of study drug, showing total sinus opacification or an air-fluid level
- Agree to a maxillary sinus puncture and catheter placement
- If female, using birth control
Key exclusion criteria (6 listed)
- Chronic sinusitis
- Need for hospitalization or intravenous antibiotics
- History of head, neck, or nasal cancer or surgery
- Previous allergy, serious adverse reaction to, or failed therapy with, levofloxacin or any other member of the quinolone class
- Presence or history of serious complications of 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 |
|---|---|---|
| levofloxacin | Drug | – |
Primary outcome
Time to bacteriological eradication, defined as the complete eradication of original strain(s) from the sinus, by the 5th day of levofloxacin treatment.
1 secondary outcome
Efficacy: Clinical response on Day 5 and at the Post-Therapy Visit (Days 12-19); plasma and sinus aspirate concentrations on Days 2-4; levels of inflammatory mediators on Days 0-5. Safety: Adverse events, vital signs, and clinical laboratory tests.
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 10 Jun 2011.
- Results publication: PubMed 17178300Anon JB, Paglia M, Xiang J, Ambrose PG, Jones RN, Kahn JB. Serial sinus aspirate samples during high-dose, short-course levofloxacin treatment of acute maxillary sinusitis. Diagn Microbiol Infect Dis. 2007 Jan;57(1):105-7. doi: 10.1016/j.diagmicrobio.2006.10.019.
- An Open-Label, Non-Comparative Sinus Puncture Study of 750 MG, Short-Course Levofloxacin in Acute Maxillary SinusitisLink 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.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing levofloxacin in people with Maxillary Sinusitis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 5 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 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Time to bacteriological eradication, defined as the complete eradication of original strain(s) from the sinus, by the 5th day of levofloxacin treatment.. 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 NCT00236652, 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 10 Jun 2011.