Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-02 @ 6:17 PM
Study NCT ID:
NCT00644293
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2008-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010612', 'term': 'Pharyngitis'}, {'id': 'D014069', 'term': 'Tonsillitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 598}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-03', 'studyFirstSubmitDate': '2008-03-19', 'studyFirstSubmitQcDate': '2008-03-19', 'lastUpdatePostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bacteriologic response in the Bacteriologic per Protocol population', 'timeFrame': 'Test of Cure (TOC) visit (Days 24-28)'}], 'secondaryOutcomes': [{'measure': 'sponsor assessment of clinical response in the Bacteriologic per Protocol population', 'timeFrame': 'TOC visit'}, {'measure': 'bacteriologic response for the remaining study populations', 'timeFrame': 'TOC visit'}, {'measure': 'sponsor assessment of clinical response for the Bacteriologic per Protocol population', 'timeFrame': 'Long-Term Follow-Up (LTFU) visit (Days 38-45)'}, {'measure': 'bacteriologic response for the Bacteriologic per Protocol population', 'timeFrame': 'TOC visit'}, {'measure': 'summary of baseline susceptibilities', 'timeFrame': 'Study endpoint'}, {'measure': 'adverse events', 'timeFrame': 'Continuous'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pharyngitis', 'Tonsillitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661119&StudyName=A%20Multicenter%2C%20Randomized%2C%20Double-Blind%2C%20Double-Dummy%20Comparative%20Trial%20of%20Azithromycin%20Sustained%20Release%20Versus%203-Day%20Azithromycin%20for%20th', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with evidence of acute group A beta-hemolytic streptococcus (GABHS) pharyngitis/tonsillitis and a positive rapid antigen detection test or positive culture of the pharynx or tonsils for GABHS\n\nExclusion Criteria:\n\n* Patients were excluded if they had treatment with any systemic antibiotic within the previous 7 days, a history of rheumatic fever, a peritonsillar abcess, or were known carriers of GABHS.'}, 'identificationModule': {'nctId': 'NCT00644293', 'briefTitle': 'A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Three-Day Azithromycin for the Treatment of Group A β-Hemolytic Streptococcal Pharyngitis/Tonsillitis in Adolescents and Adults', 'orgStudyIdInfo': {'id': 'A0661119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: azithromycin (Zithromax)', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: azithromycin SR', 'Drug: placebo']}], 'interventions': [{'name': 'azithromycin (Zithromax)', 'type': 'DRUG', 'description': 'azithromycin 500 mg tablet by mouth once daily for 3 days', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['1']}, {'name': 'azithromycin SR', 'type': 'DRUG', 'description': 'azithromycin SR 2.0 g by mouth as an oral slurry for 1 dose', 'armGroupLabels': ['2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '83651', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83703', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83704', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83709', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '83651', 'city': 'Nampa', 'state': 'Idaho', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.54072, 'lon': -116.56346}}, {'zip': '68144', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '97404', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '19020', 'city': 'Bensalem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.10455, 'lon': -74.95128}}, {'zip': '19438', 'city': 'Harleysville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.27955, 'lon': -75.38712}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}, {'zip': '9320', 'city': 'Erembodegem', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.91905, 'lon': 4.05041}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '37100', 'city': 'Nokia', 'country': 'Finland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 61.46667, 'lon': 23.5}}, {'zip': '33200', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '92 400', 'city': 'Courbevoie', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.89672, 'lon': 2.25666}}, {'zip': '94 250', 'city': 'Gentilly', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.81294, 'lon': 2.3417}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '34 000', 'city': 'Montpellier', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '76 100', 'city': 'Rouen', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '94 800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '10965', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13593', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '15537', 'city': 'Erkner', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.42, 'lon': 13.75437}}, {'zip': '67069', 'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'zip': '15562', 'city': 'Rüdersdorf', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.46927, 'lon': 13.78631}}, {'zip': 'D-21255', 'city': 'Tostedt', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.28333, 'lon': 9.71667}}, {'zip': '78054', 'city': 'Villingen-Schwenningen', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.06226, 'lon': 8.49358}}, {'zip': '97070', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '560 0344', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '682 026', 'city': 'Kochi', 'state': 'Kerala', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 9.93988, 'lon': 76.26022}}, {'zip': '500 033', 'city': 'Hyderabad', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '411 004', 'city': 'Pune', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '06034', 'city': 'Foligno', 'state': 'PG', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.95488, 'lon': 12.70268}}, {'zip': '06023', 'city': 'Gualdo Tadino', 'state': 'PG', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.22941, 'lon': 12.77862}}, {'zip': '06087', 'city': 'S.Eraclio-Foligno', 'state': 'PG', 'country': 'Italy', 'facility': 'Pfizer Investigational Site'}, {'zip': '06049', 'city': 'Spoleto', 'state': 'PG', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.74071, 'lon': 12.73899}}, {'zip': '06020', 'city': 'Vocabolo Gaifana-Gualdo Tadino', 'state': 'PG', 'country': 'Italy', 'facility': 'Pfizer Investigational Site'}, {'zip': '6711 PS', 'city': 'Ede (Gld)', 'country': 'Netherlands', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.03333, 'lon': 5.65833}}, {'zip': '4191 AH', 'city': 'Geldermalsen', 'country': 'Netherlands', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.88083, 'lon': 5.28889}}, {'zip': '1271 BB', 'city': 'Huizen', 'country': 'Netherlands', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.29917, 'lon': 5.24167}}, {'zip': '2402', 'city': 'Elverum', 'country': 'Norway', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 60.88191, 'lon': 11.56231}}, {'zip': '2020', 'city': 'Skedsmokorset', 'country': 'Norway', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 60.00459, 'lon': 11.03278}}, {'zip': 'BA2 3HT', 'city': 'Bath', 'state': 'Avon', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'zip': 'TN34 3EY', 'city': 'Hastings', 'state': 'East Sussex', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.85568, 'lon': 0.58009}}, {'zip': 'KY6 3LQ', 'city': 'Glenrothes', 'state': 'Fife', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 56.19514, 'lon': -3.17316}}, {'zip': 'KY12 8SJ', 'city': 'High Valleyfield', 'state': 'Fife', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 56.06357, 'lon': -3.59913}}, {'zip': 'TN1 2EP', 'city': 'Tunbrige Wells', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site'}, {'zip': 'CV9 1EU', 'city': 'Atherstone', 'state': 'Warwickshire', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.57536, 'lon': -1.54693}}, {'zip': 'CV7 8LA', 'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'TN1 2DX', 'city': 'Kent', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.27893, 'lon': 0.52021}}, {'zip': 'TN10 3ET', 'city': 'Kent', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.27893, 'lon': 0.52021}}, {'zip': 'TN11 9HL', 'city': 'Kent', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.27893, 'lon': 0.52021}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Group', 'oldOrganization': 'Pfizer, Inc.'}}}}