Maxillary SinusitisEASYNCT01032174
Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis
An observational study of Maxillary Sinusitis, run by Pfizer.
Trial summary
The purpose of this study is to compare compliance between patients with Acute Bacterial Sinusitis (ABS) treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of ABS in outpatient clinic practice. 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 and Amoxiclav 1000 mg
- Type of treatment
- Pill or oral medicine
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Mar 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Patients with Acute Maxillary Sinusitis
Who may be able to join
- Male or nor pregnant or lactating female outpatients, 18 years of age or older.
- A clinical diagnosis of acute bacterial uncomplicated maxillary sinusitis as demonstrated by presence of the following signs and symptoms for a minimum duration of 7-10 days:
- Facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and
- Presence of one or more of the following signs:
- i.purulent nasal discharge ii.purulent drainage in the posterior pharynx iii.purulent discharge from the maxillary sinus orifice
- A sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis. At least one of the following must be documented in one or both maxillary sinuses on radiologic examination:
Show all 13Show fewer
- complete or partial opacification
- an air/fluid level
- Two or more of the following:
- fever, as defined by temperature: >38ºC
- leukocytosis [White Blood Cell (WBC) >10,000/mm3 or >15% band forms], ECR;
- headache,
- nasal congestion and post nasal drainage.
Who cannot join
- Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin, Amoxiclav according to LPDs, pregnant or lactating women.
About this study
The purpose of this study is to compare compliance between patients with Acute Bacterial Sinusitis (ABS) treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of ABS in outpatient clinic practice.
- Conditions
- Maxillary Sinusitis
- Being tested
- Azithromycin SR, Amoxiclav 1000 mg
- Keywords
- Azithromycin SR Amoxiclav 1000 mg Maxillary Sinusitis
- 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 SRDrug
Azithromycin SR, 2.0 g by mouth (PO) x 1
Amoxiclav 1000 mgDrug
Amoxiclav 1000 mg x twice daily, 10 days
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin SR | Acute Bacterial Maxillary Sinusitis Receives: Drug: Azithromycin SR | |
| Amoxiclav 1000 mg | Acute Bacterial Maxillary Sinusitis Receives: Drug: Amoxiclav 1000 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Response of Very Convenient or Somewhat Convenient
Participant reported outcome questionnaire was the assessment of participant's convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered 'very convenient' or 'somewhat convenient' and 0 if participant answered 'not convenient' or 'not at all convenient'.
Measured: Day 11
Secondary outcomes (2)
Percent Compliance With Prescribed Treatment Regimen
Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed).
Measured: Day 11
Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen
Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). Value of 1 was reported if percent compliance equals to 100, and 0 if percent compliance was non-missing and less than 100.
Measured: Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startApr 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032174
- Sponsor's protocol ID
- A0661199
- Acronym
- EASY
- Status last verified
- Apr 2012
- First submitted
- 14 Dec 2009
- Last updated
- 16 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis
- ClinicalTrials.gov ID
- NCT01032174
- Acronym / sponsor ID
- EASY / A0661199
- Conditions
- Maxillary Sinusitis
- Keywords
- Azithromycin SR Amoxiclav 1000 mg Maxillary Sinusitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Posted 22 Mar 2012
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 compare compliance between patients with Acute Bacterial Sinusitis (ABS) treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of ABS in outpatient clinic practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin SR | – | Drug: Azithromycin SRAcute Bacterial Maxillary Sinusitis |
| Amoxiclav 1000 mg | – | Drug: Amoxiclav 1000 mgAcute Bacterial Maxillary Sinusitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Acute Maxillary Sinusitis
Key inclusion criteria (13 listed)
- Male or nor pregnant or lactating female outpatients, 18 years of age or older.
- A clinical diagnosis of acute bacterial uncomplicated maxillary sinusitis as demonstrated by presence of the following signs and symptoms for a minimum duration of 7-10 days:
- i.purulent nasal discharge ii.purulent drainage in the posterior pharynx iii.purulent discharge from the maxillary sinus orifice
- A sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis. At least one of the following must be documented in one or both maxillary sinuses on radiologic examination:
- fever, as defined by temperature: >38ºC
Key exclusion criteria (1 listed)
- Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin, Amoxiclav according to LPDs, pregnant or lactating women.
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 SRAzithromycin SR, 2.0 g by mouth (PO) x 1 | Drug | Azithromycin SR |
| Amoxiclav 1000 mgAmoxiclav 1000 mg x twice daily, 10 days | Drug | Amoxiclav 1000 mg |
Primary outcome
Percentage of Participants With Response of Very Convenient or Somewhat Convenient
Time frame: Day 11
Participant reported outcome questionnaire was the assessment of participant's convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered 'very convenient' or 'somewhat convenient' and 0 if participant answered 'not convenient' or 'not at all convenient'.
2 secondary outcomes
Percent Compliance With Prescribed Treatment Regimen
Time frame: Day 11
Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen
Time frame: Day 11
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Maxillary Sinusitis
Recruiting
Single-step Functional Sinus Endoscopy and Transoral Surgery
Maxillary Sinusitis
Not yet recruitingObservational study
Deviated Nasal Septum Effect on Maxillary Sinus Volumes and Development of Maxillary Sinusitis by CT
Deviated Nasal Septum and Maxillary Sinusitis
Recruiting
Balloon Sinuplasty Efficiency in Maxillary Rhinosinusitis.
Maxillary Sinusitis, Sinusitis, Chronic
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
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillary Sinusitis, run by Pfizer.
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 13 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 16 Apr 2012. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Response of Very Convenient or Somewhat Convenient (time frame: Day 11). 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 16 Apr 2012.