An observational study in Community-Acquired Pneumonia, sponsored by Pfizer. Terminated. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-12-21.
Sponsored by Pfizer · Observational
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 30 is below the median of 203 across 688 observational studies indexed under Pneumonia.
Browse Pneumonia studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with Community-Acquired Pneumonia.
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:
Exclusion Criteria:
Patients with Community-Acquired Pneumonia
Drug: Azithromycin SR
Patients with Community-Acquired Pneumonia
Drug: Amoxiclav
Azithromycin SR, 2.0 g PO x 1 dose for treatment period
Amoxiclav 1000 x twice daily, 10 days duration
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
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
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
| Milestone | Azithromycin | Amoxiclav |
|---|---|---|
| Started | 20 | 10 |
| Completed | 20 | 10 |
| Not completed | 0 | 0 |
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'.
| Percentage of Participants | Azithromycin | Amoxiclav |
|---|---|---|
| Percentage of Participants With Response of Very Convenient or Somewhat Convenient | 100 | 100 |
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).
| Percent compliance | Azithromycin | Amoxiclav |
|---|---|---|
| Percent Compliance With the Prescribed Treatment Regimen | 100.0 ± 0.0 | 100.0 ± 0.0 |
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.
| Percentage of Participants | Azithromycin | Amoxiclav |
|---|---|---|
| Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen | 100 | 100 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Azithromycin | — | 0/20 (0%) | 2/20 (10%) |
| Amoxiclav | — | 0/10 (0%) | 0/10 (0%) |
| Event | Azithromycin | Amoxiclav |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/20 | 0/10 |
| VomitingGastrointestinal disorders | 1/20 | 0/10 |
| Age Continuous(Years) | Azithromycin | Amoxiclav | Total |
|---|---|---|---|
| Mean | 45.8 ± 18.0 | 40.1 ± 7.9 | 43.9 ± 15.4 |
| Sex: Female, Male(Participants) | Azithromycin | Amoxiclav | Total |
|---|---|---|---|
| Female | 10 | 5 | 15 |
| Male | 10 | 5 | 15 |
No study locations are listed for this record.
This study is terminated, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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