Community-Acquired Pneumonia
Conditions
Keywords
Community-Acquired Pneumonia, Azithromycin SR, Amoxiclav
Brief summary
To compare compliance between patients with CAP 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 CAP in outpatient clinic practice.
Interventions
DRUGAzithromycin SR
Azithromycin SR, 2.0 g PO x 1 dose for treatment period
DRUGAmoxiclav
Amoxiclav 1000 x twice daily, 10 days duration
Sponsors
Pfizer
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Males or not pregnant or lactating females, 18 years of age or older, for whom oral antibacterial therapy is indicated with clinically evidence of Diagnosis of pneumonia, based on usual clinical practice: 1. Physical examination and auscultatory findings (dullness on percussion, bronchial breath sounds, egophony, dry or fine most rales). 2. Body temperature \>38 degrees C.
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 | Days 11-12 | 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 the Prescribed Treatment Regimen | Days 11-12 | 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 | Days 11-12 | 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. | 20 |
| Amoxiclav Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days. | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | Azithromycin | Amoxiclav | Total |
|---|---|---|---|
| Age Continuous | 45.8 Years STANDARD_DEVIATION 18 | 40.1 Years STANDARD_DEVIATION 7.9 | 43.9 Years STANDARD_DEVIATION 15.4 |
| Sex: Female, Male Female | 10 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 20 | 0 / 10 |
| serious Total, serious adverse events | 0 / 20 | 0 / 10 |
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: Days 11-12
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. Missing observations were not imputed. 'N' signifies the number of participants with non-missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin | Percentage of Participants With Response of Very Convenient or Somewhat Convenient | 100 Percentage of Participants |
| Amoxiclav | Percentage of Participants With Response of Very Convenient or Somewhat Convenient | 100 Percentage of Participants |
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: Days 11-12
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 Percentage of Participants |
| Amoxiclav | Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen | 100 Percentage of Participants |
Secondary
Percent Compliance With the 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: Days 11-12
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 the Prescribed Treatment Regimen | 100.0 Percent compliance | Standard Deviation 0 |
| Amoxiclav | Percent Compliance With the Prescribed Treatment Regimen | 100.0 Percent compliance | Standard Deviation 0 |