Maxillary Sinusitis
Conditions
Keywords
Azithromycin SR Amoxiclav 1000 mg Maxillary Sinusitis
Brief 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.
Interventions
DRUGAzithromycin SR
Azithromycin SR, 2.0 g by mouth (PO) x 1
DRUGAmoxiclav 1000 mg
Amoxiclav 1000 mg x twice daily, 10 days
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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: 1. 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 2. 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: 1. complete or partial opacification 2. an air/fluid level Two or more of the following: 1. fever, as defined by temperature: \>38ºC 2. leukocytosis \[White Blood Cell (WBC) \>10,000/mm3 or \>15% band forms\], ECR; 3. headache, 4. nasal congestion and post nasal drainage.
Exclusion criteria
* Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin, Amoxiclav according to LPDs, pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Response of Very Convenient or Somewhat Convenient | 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'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Compliance With Prescribed Treatment Regimen | Day 11 | 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). |
| Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen | Day 11 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Azithromycin A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally. | 63 |
| Amoxiclav Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days. | 60 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Azithromycin | Amoxiclav | Total |
|---|---|---|---|
| Age Continuous | 36.9 years STANDARD_DEVIATION 11.6 | 38.4 years STANDARD_DEVIATION 13.4 | 37.6 years STANDARD_DEVIATION 12.5 |
| Sex: Female, Male Female | 30 Participants | 34 Participants | 64 Participants |
| Sex: Female, Male Male | 33 Participants | 26 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 63 | 9 / 60 |
| serious Total, serious adverse events | 0 / 63 | 0 / 60 |
Outcome results
Primary
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'.
Time frame: Day 11
Population: The Full Analysis Set (FAS) population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation. 'N' signifies number of participants with non-missing data. Missing observations were not imputed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin | Percentage of Participants With Response of Very Convenient or Somewhat Convenient | 100.0 Percentage of Participants |
| Amoxiclav | Percentage of Participants With Response of Very Convenient or Somewhat Convenient | 72.9 Percentage of Participants |
p-value: <0.0001Regression, Logistic
Secondary
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.
Time frame: Day 11
Population: The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin | Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen | 100.0 Percentage of Participants |
| Amoxiclav | Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen | 91.7 Percentage of Participants |
p-value: 0.0682Regression, Logistic
Secondary
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).
Time frame: Day 11
Population: The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Azithromycin | Percent Compliance With Prescribed Treatment Regimen | 100.00 Percent compliance | Standard Deviation 0 |
| Amoxiclav | Percent Compliance With Prescribed Treatment Regimen | 99.00 Percent compliance | Standard Deviation 3.88 |
p-value: 0.056895% CI: [-0.03, 2.15]ANCOVA