Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:10 PM
Study NCT ID:
NCT01032694
Status:
TERMINATED
Last Update Posted:
2011-12-21
First Post:
2009-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019980', 'term': 'Amoxicillin-Potassium Clavulanate Combination'}], 'ancestors': [{'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'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.', 'eventGroups': [{'id': 'EG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.', 'otherNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Amoxiclav', 'description': 'Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Response of Very Convenient or Somewhat Convenient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.'}, {'id': 'OG001', 'title': 'Amoxiclav', 'description': 'Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 11-12', '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'.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', 'title': 'Percent Compliance With the Prescribed Treatment Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.'}, {'id': 'OG001', 'title': 'Amoxiclav', 'description': 'Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '100.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 11-12', '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).', 'unitOfMeasure': 'Percent compliance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.'}, {'id': 'OG001', 'title': 'Amoxiclav', 'description': 'Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 11-12', '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.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.'}, {'id': 'FG001', 'title': 'Amoxiclav', 'description': 'Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Azithromycin', 'description': 'A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.'}, {'id': 'BG001', 'title': 'Amoxiclav', 'description': 'Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'spread': '18.0', 'groupId': 'BG000'}, {'value': '40.1', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '43.9', 'spread': '15.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'This study was terminated January 11, 2011 due to low enrollment. This study is not being terminated because of safety or efficacy concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-21', 'studyFirstSubmitDate': '2009-12-14', 'resultsFirstSubmitDate': '2011-11-21', 'studyFirstSubmitQcDate': '2009-12-14', 'lastUpdatePostDateStruct': {'date': '2011-12-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-21', 'studyFirstPostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Response of Very Convenient or Somewhat Convenient', 'timeFrame': 'Days 11-12', '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'."}], 'secondaryOutcomes': [{'measure': 'Percent Compliance With the Prescribed Treatment Regimen', 'timeFrame': 'Days 11-12', '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).'}, {'measure': 'Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen', 'timeFrame': 'Days 11-12', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Community-Acquired Pneumonia', 'Azithromycin SR', 'Amoxiclav'], 'conditions': ['Community-Acquired Pneumonia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661200&StudyName=Non-Interventional%20Open%20Label%20Prospective%20Observational%20Comparative%20Study%20On%20Evaluation%20Of%20Compliance%20Of%20The%20Empiric%20Treatment%20With%20Azithromyc', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Community-Acquired Pneumonia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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:\n\n 1. Physical examination and auscultatory findings (dullness on percussion, bronchial breath sounds, egophony, dry or fine most rales).\n 2. Body temperature \\>38 degrees C.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin.\n* Amoxiclav according to LPDs, pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT01032694', 'acronym': 'PROSTO', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'A0661200'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Z-max treated group', 'description': 'Patients with Community-Acquired Pneumonia', 'interventionNames': ['Drug: Azithromycin SR']}, {'label': 'Amoxiclav treated group', 'description': 'Patients with Community-Acquired Pneumonia', 'interventionNames': ['Drug: Amoxiclav']}], 'interventions': [{'name': 'Azithromycin SR', 'type': 'DRUG', 'description': 'Azithromycin SR, 2.0 g PO x 1 dose for treatment period', 'armGroupLabels': ['Z-max treated group']}, {'name': 'Amoxiclav', 'type': 'DRUG', 'description': 'Amoxiclav 1000 x twice daily, 10 days duration', 'armGroupLabels': ['Amoxiclav treated group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}