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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 (EASY)

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ClinicalTrials.gov Identifier: NCT01032174
Recruitment Status : Completed
First Posted : December 15, 2009
Results First Posted : March 22, 2012
Last Update Posted : April 16, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Maxillary Sinusitis
Interventions Drug: Azithromycin SR
Drug: Amoxiclav 1000 mg
Enrollment 123
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Azithromycin Amoxiclav
Hide 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 63 60
Completed 63 59
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Arm/Group Title Azithromycin Amoxiclav Total
Hide 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 Number of Baseline Participants 63 60 123
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 60 participants 123 participants
36.9  (11.6) 38.4  (13.4) 37.6  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 60 participants 123 participants
Female
30
  47.6%
34
  56.7%
64
  52.0%
Male
33
  52.4%
26
  43.3%
59
  48.0%
1.Primary Outcome
Title Percentage of Participants With Response of Very Convenient or Somewhat Convenient
Hide 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 Day 11
Hide Outcome Measure Data
Hide 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. 'N' signifies number of participants with non-missing data. Missing observations were not imputed.
Arm/Group Title Azithromycin Amoxiclav
Hide 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.
Overall Number of Participants Analyzed 63 59
Measure Type: Number
Unit of Measure: Percentage of Participants
100.0 72.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin, Amoxiclav
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The logistic regression model contained terms for treatment, gender and age.
Method Regression, Logistic
Comments [Not Specified]
2.Secondary Outcome
Title Percent Compliance With Prescribed Treatment Regimen
Hide 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 Day 11
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 63 60
Mean (Standard Deviation)
Unit of Measure: Percent compliance
100.00  (0.00) 99.00  (3.88)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin, Amoxiclav
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0568
Comments The analysis of covariance (ANCOVA) model contained terms for treatment, gender, age and Body Mass Index (BMI).
Method ANCOVA
Comments Least square mean was adjusted for gender, age and BMI.
Method of Estimation Estimation Parameter Difference of Least Square Mean
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
-0.03 to 2.15
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.55
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen
Hide 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 Day 11
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 63 60
Measure Type: Number
Unit of Measure: Percentage of Participants
100.0 91.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin, Amoxiclav
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0682
Comments The logistic regression model contained terms for treatment, gender and age.
Method Regression, Logistic
Comments [Not Specified]
Time Frame [Not Specified]
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
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Azithromycin Amoxiclav
Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)   0/60 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Azithromycin Amoxiclav
Affected / at Risk (%) Affected / at Risk (%)
Total   7/63 (11.11%)   9/60 (15.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/63 (1.59%)  0/60 (0.00%) 
Constipation * 1  1/63 (1.59%)  0/60 (0.00%) 
Diarrhoea * 1  2/63 (3.17%)  3/60 (5.00%) 
Dyspepsia * 1  2/63 (3.17%)  1/60 (1.67%) 
Flatulence * 1  1/63 (1.59%)  2/60 (3.33%) 
Infections and infestations     
Vulvovaginal candidiasis * 1  0/63 (0.00%)  4/60 (6.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01032174    
Other Study ID Numbers: A0661199
First Submitted: December 14, 2009
First Posted: December 15, 2009
Results First Submitted: February 21, 2012
Results First Posted: March 22, 2012
Last Update Posted: April 16, 2012