Trial Outcomes & Findings for 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 (NCT NCT01032174)
NCT ID: NCT01032174
Last Updated: 2012-04-16
Results Overview
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'.
COMPLETED
123 participants
Day 11
2012-04-16
Participant Flow
Participant milestones
| Measure |
Azithromycin
A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
|
Amoxiclav
Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
60
|
|
Overall Study
COMPLETED
|
63
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Azithromycin
A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
|
Amoxiclav
Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Azithromycin
n=63 Participants
A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
|
Amoxiclav
n=60 Participants
Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
36.9 years
STANDARD_DEVIATION 11.6 • n=99 Participants
|
38.4 years
STANDARD_DEVIATION 13.4 • n=107 Participants
|
37.6 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 11Population: 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.
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'.
Outcome measures
| Measure |
Azithromycin
n=63 Participants
A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
|
Amoxiclav
n=59 Participants
Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
|
|---|---|---|
|
Percentage of Participants With Response of Very Convenient or Somewhat Convenient
|
100.0 Percentage of Participants
|
72.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 11Population: The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.
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).
Outcome measures
| Measure |
Azithromycin
n=63 Participants
A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
|
Amoxiclav
n=60 Participants
Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
|
|---|---|---|
|
Percent Compliance With Prescribed Treatment Regimen
|
100.00 Percent compliance
Standard Deviation 0.00
|
99.00 Percent compliance
Standard Deviation 3.88
|
SECONDARY outcome
Timeframe: Day 11Population: The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.
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.
Outcome measures
| Measure |
Azithromycin
n=63 Participants
A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
|
Amoxiclav
n=60 Participants
Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
|
|---|---|---|
|
Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen
|
100.0 Percentage of Participants
|
91.7 Percentage of Participants
|
Adverse Events
Azithromycin
Amoxiclav
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Azithromycin
n=63 participants at risk
A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
|
Amoxiclav
n=60 participants at risk
Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/63
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/60
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/63
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/60
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
2/63
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.0%
3/60
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.2%
2/63
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.7%
1/60
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
1/63
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
2/60
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/63
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
4/60
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER