Maxillary SinusitisPhase 4NCT00245440
Study to Measure the Impact of Antibiotics on Bacterial Flora in Adults With Acute Sinusitis
A Phase 4 study testing Azithromycin and Telithromycin in people with Maxillary Sinusitis, run by CPL Associates at 1 site in United States.
Trial summary
The purpose of this study is to measure the speed of microbial eradication due to azithromycin or telithromycin in acute maxillary sinusitis (AMS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Maxillary Sinusitis
- What is being tested?
- Azithromycin and Telithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jul 2006
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, either males or non-pregnant females, aged 18 to 75 years of age with clinical findings of acute maxillary sinusitis (AMS), who are amenable to serial sampling of the nasopharynx and oropharynx.
- Patients are required to have specimens of nasal and nasopharyngeal drainage collected for microbiological documentation within 24 hours prior to enrollment. All patients must produce sinus fluid drainage.
- All patients will produce nasal or nasopharyngeal discharge sufficient for baseline culture.
- Female patients of child bearing potential must agree to use an accepted method of contraception (i.e., oral or implanted contraceptive with a barrier method, spermicide and barrier methods, or intrauterine device [IUD]). The patient must agree to continue with the same method throughout the study.
Who cannot join
- Patients with a history of recurrent sinusitis defined as more than three episodes of sinusitis which required antibiotic therapy in the preceding 12 months
- Patients with a history of chronic sinusitis defined as symptoms lasting greater than 28 days
- Patients with nosocomial acquired sinusitis (e.g., hospitalization or non-ambulatory institutional confinement including nursing homes within 2 weeks)
- Patients with a need for immediate surgery for maxillary sinusitis or previous sinus surgery within the past 6 months or sinus lavage within the past 7 days
- Patients who are long-term (> 4 weeks) users of nasal decongestants (e.g. oxymetazoline 0.05%)
- Patients with a known or suspected hypersensitivity to, or a known or suspected serious adverse reaction to, any macrolide antibiotic
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- Impaired hepatic or renal function (creatinine clearance [CCL] <20 ml/min)
- Severe respiratory tract infections requiring hospitalization and parenteral antibiotic therapy.
- Requirement for a concomitant antimicrobial agent other than topical, antiviral or antifungal agents.
- Treatment with any macrolide, azalide, or ketolide antimicrobial within the 30 days prior to entry into the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southeastern Researchs Associates,Inc.
Taylors, South Carolina, 29687
About this study
Official title: Influence of Oral Telithromycin vs. Azithromycin on the Endogenous Microflora in Adults With Acute Sinusitis
The purpose of this study is to measure the speed of microbial eradication due to azithromycin or telithromycin in acute maxillary sinusitis (AMS).
Read the detailed description
The objectives of this study are:
- To assess the impact of therapy with telithromycin vs. azithromycin on the oral microflora in patients with acute maxillary sinusitis at day 42 and to compare the duration of colonization with resistant oropharyngeal flora in patients treated with azithromycin vs. telithromycin.
- To also compare the two treatment groups for rate of reinfection within 6 weeks and the susceptibility pattern of the organisms appearing during the reinfection and differences in development of resistance and the associated changes in symptom responses.
- Conditions
- Maxillary Sinusitis
- Being tested
- Azithromycin, Telithromycin
- Keywords
- S.pneumonia, sinusitis, ams, azithromycin
- Medical subject headings
- Maxillary Sinusitis, Sinusitis, Focal Facial Dermal Dysplasias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
250 mg tablets; 2 tablets once daily (500 mg) for 3 days
TelithromycinDrug
400 mg tablets; 2 tablets once daily (800 mg) for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Subjects assigned Azithromycin Receives: Drug: Azithromycin |
| 2 | Active comparator | Subjects assigned Telithromycin Receives: Drug: Telithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial resistance or selection
Measured: 42 days
Secondary outcomes (1)
Bacteriologic outcome
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startDec 2005
- Study completionJul 2006
Why it stopped: Sponsor Terminated
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.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- CPL Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Jerome J Schentag, Pharm.D., Principal investigator, State University of NY at BuffaloJoseph Paladino, Pharm.D., Study director, State University of NY at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245440
- Sponsor's protocol ID
- HMR3647A-6045
- Status last verified
- Oct 2007
- First submitted
- 26 Oct 2005
- Last updated
- 31 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Oral Telithromycin vs. Azithromycin on the Endogenous Microflora in Adults With Acute Sinusitis
- ClinicalTrials.gov ID
- NCT00245440
- Acronym / sponsor ID
- HMR3647A-6045
- Conditions
- Maxillary Sinusitis
- Keywords
- S.pneumonia, sinusitis, ams, azithromycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Terminated
- Enrolment
- 192 participants (actual)
- Lead sponsor
- CPL AssociatesUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Dec 2005
- Study completion
- Jul 2006 (actual)
- First posted
- 28 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 measure the speed of microbial eradication due to azithromycin or telithromycin in acute maxillary sinusitis (AMS).
Detailed description
The objectives of this study are:
- To assess the impact of therapy with telithromycin vs. azithromycin on the oral microflora in patients with acute maxillary sinusitis at day 42 and to compare the duration of colonization with resistant oropharyngeal flora in patients treated with azithromycin vs. telithromycin.
- To also compare the two treatment groups for rate of reinfection within 6 weeks and the susceptibility pattern of the organisms appearing during the reinfection and differences in development of resistance and the associated changes in symptom responses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AzithromycinSubjects assigned Azithromycin |
| 2 | Active comparator | Drug: TelithromycinSubjects assigned Telithromycin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients, either males or non-pregnant females, aged 18 to 75 years of age with clinical findings of acute maxillary sinusitis (AMS), who are amenable to serial sampling of the nasopharynx and oropharynx.
- Patients are required to have specimens of nasal and nasopharyngeal drainage collected for microbiological documentation within 24 hours prior to enrollment. All patients must produce sinus fluid drainage.
- All patients will produce nasal or nasopharyngeal discharge sufficient for baseline culture.
- Female patients of child bearing potential must agree to use an accepted method of contraception (i.e., oral or implanted contraceptive with a barrier method, spermicide and barrier methods, or intrauterine device [IUD]). The patient must agree to continue with the same method throughout the study.
Key exclusion criteria (10 listed)
- Patients with a history of recurrent sinusitis defined as more than three episodes of sinusitis which required antibiotic therapy in the preceding 12 months
- Patients with a history of chronic sinusitis defined as symptoms lasting greater than 28 days
- Patients with nosocomial acquired sinusitis (e.g., hospitalization or non-ambulatory institutional confinement including nursing homes within 2 weeks)
- Patients with a need for immediate surgery for maxillary sinusitis or previous sinus surgery within the past 6 months or sinus lavage within the past 7 days
- Patients who are long-term (> 4 weeks) users of nasal decongestants (e.g. oxymetazoline 0.05%)
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 |
|---|---|---|
| Azithromycin250 mg tablets; 2 tablets once daily (500 mg) for 3 days | Drug | 1 |
| Telithromycin400 mg tablets; 2 tablets once daily (800 mg) for 5 days | Drug | 2 |
Primary outcome
Bacterial resistance or selection
Time frame: 42 days
1 secondary outcome
Bacteriologic outcome
Time frame: 42 days
Results and safety
The study was stopped early (reason given: Sponsor Terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2007.
- Related InfoLink 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.
Jerome J Schentag, Pharm.D. principal investigator
State University of NY at Buffalo
Joseph Paladino, Pharm.D. study director
State University of NY at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin and Telithromycin in people with Maxillary Sinusitis, run by CPL Associates at 1 site in United States.
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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 31 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: Sponsor Terminated). Results are not available in the source record.
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?
Bacterial resistance or selection (time frame: 42 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 31 Oct 2007.