PROSTO: 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

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01032694
• Collaborator: (none)
• Enrollment: 30
• Duration (Months): 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Community-Acquired Pneumonia	Drug: Azithromycin SR; Drug: Amoxiclav

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: 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
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Z-max treated group Patients with Community-Acquired Pneumonia	Drug: Azithromycin SR; Azithromycin SR, 2.0 g PO x 1 dose for treatment period
Amoxiclav treated group Patients with Community-Acquired Pneumonia	Drug: Amoxiclav; Amoxiclav 1000 x twice daily, 10 days duration

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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).

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01032694
• Other Study ID Numbers: A0661200
• First Posted: Dec 15, 2009
• Last Update Posted: Dec 21, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Pfizer: Community-Acquired Pneumonia; Azithromycin SR; Amoxiclav
• Additional relevant MeSH terms: Pneumonia; Azithromycin

Study Results

Participant Flow

Arm/Group Title	Azithromycin	Amoxiclav
Arm/Group Description	A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.	Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
Period Title: Overall Study
STARTED	20	10
COMPLETED	20	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Azithromycin	Amoxiclav	Total
Arm/Group Description	A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.	Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.	Total of all reporting groups
Overall Participants	20	10	30
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	45.8 (18.0)	40.1 (7.9)	43.9 (15.4)
Sex: Female, Male (Count of Participants)
Female	10 50%	5 50%	15 50%
Male	10 50%	5 50%	15 50%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Response of Very Convenient or Somewhat Convenient
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Azithromycin	Amoxiclav
Arm/Group Description	A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.	Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
Measure Participants	19	6
Number [Percentage of Participants]	100 500%	100 1000%

2. Secondary Outcome

Title	Percent Compliance With the Prescribed Treatment Regimen
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Azithromycin	Amoxiclav
Arm/Group Description	A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.	Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
Measure Participants	20	10
Mean (Standard Deviation) [Percent compliance]	100.0 (0.0)	100.0 (0.0)

3. Secondary Outcome

Title	Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Azithromycin	Amoxiclav
Arm/Group Description	A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.	Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
Measure Participants	20	10
Number [Percentage of Participants]	100 500%	100 1000%

Adverse Events

Adverse Event Reporting Description	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.
Arm/Group Title	Azithromycin		Amoxiclav
Arm/Group Description	A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.		Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
All Cause Mortality
	Azithromycin		Amoxiclav
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Azithromycin		Amoxiclav
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Azithromycin		Amoxiclav
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10%)		0/10 (0%)
Gastrointestinal disorders
Diarrhoea	1/20 (5%)		0/10 (0%)
Vomiting	1/20 (5%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.