Trial Outcomes & Findings for Non-Interventional Open Label Prospective Observational Comparative Study On Evaluation Of Compliance Of The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Mild To Moderate Community Acquired Pneumonia (NCT NCT01032694)

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'.

Recruitment status

TERMINATED

Target enrollment

30 participants

Primary outcome timeframe

Days 11-12

Results posted on

2011-12-21

Participant Flow

Participant milestones

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	20	10
Overall Study COMPLETED	20	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non-Interventional Open Label Prospective Observational Comparative Study On Evaluation Of Compliance Of The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Mild To Moderate Community Acquired Pneumonia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Azithromycin n=20 Participants A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.	Amoxiclav n=10 Participants Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.	Total n=30 Participants Total of all reporting groups
Age Continuous	45.8 Years STANDARD_DEVIATION 18.0 • n=5 Participants	40.1 Years STANDARD_DEVIATION 7.9 • n=7 Participants	43.9 Years STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures
Measure	Azithromycin n=19 Participants A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.	Amoxiclav n=6 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 Percentage of Participants	100 Percentage of Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures
Measure	Azithromycin n=20 Participants A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.	Amoxiclav n=10 Participants Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
Percent Compliance With the Prescribed Treatment Regimen	100.0 Percent compliance Standard Deviation 0.0	100.0 Percent compliance Standard Deviation 0.0

SECONDARY outcome

Timeframe: 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.

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

Outcome measures
Measure	Azithromycin n=20 Participants A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.	Amoxiclav n=10 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 Percentage of Participants	100 Percentage of Participants

Adverse Events

Azithromycin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Amoxiclav

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Azithromycin n=20 participants at risk A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.	Amoxiclav n=10 participants at risk Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
Gastrointestinal disorders Diarrhoea	5.0% 1/20 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% 0/10 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 Vomiting	5.0% 1/20 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% 0/10 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

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

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