Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-04 @ 9:53 AM
Study NCT ID:
NCT00095368
Status:
COMPLETED
Last Update Posted:
2006-12-08
First Post:
2004-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat
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': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-04', 'completionDateStruct': {'date': '2005-05'}, 'lastUpdateSubmitDate': '2006-12-06', 'studyFirstSubmitDate': '2004-11-03', 'studyFirstSubmitQcDate': '2004-11-03', 'lastUpdatePostDateStruct': {'date': '2006-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-11-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacteriological outcome at the Test of Cure Visit'}], 'secondaryOutcomes': [{'measure': 'Bacteriological outcome at the Late Post Therapy Visit'}, {'measure': 'Clinical Outcome'}, {'measure': 'Safety'}]}, 'conditionsModule': {'keywords': ['Pharyngitis', 'Tonsillitis'], 'conditions': ['Pharyngitis', 'Tonsillitis']}, 'descriptionModule': {'briefSummary': 'The purpose of the this study is to evaluate the safety of efficacy of APC-111 775 mg MP tablet once daily dosing for 7 days for treating patients with strep throat. The evaluation will look to confirm if APC-111 eliminates the bacterial infection (Streptococcus pyogenes).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Give informed consent, assent and patient authorization\n* Age 12 and over\n* A clinical diagnosis of acute pharyngitis or tonsillitis\n* A positive rapid Strep test\n* Can swallow the oral study dosage forms\n* Females must have a negative urine pregnancy test and be using acceptable birth control if sexually active\n\nExclusion Criteria:\n\n* Chronic or recurrent odynophagia\n* Need for hospitalization or IV antimicrobial therapy\n* Pharyngitis known or suspected due to a pathogen resistant to beta-lactam antimicrobials\n* Known carrier of S. pyogenes\n* Allergies to penicillin or other beta-lactam antibiotics\n* Any serious illness or concomitant condition that the investigator judges will preclude inclusion to the study\n* Seizure disorder\n* Pregnant or nursing\n* Expectation of additional systemic antibacterials would be required for another condition\n* Current drug or alcohol abuse\n* Any experimental drug or device within the last 30 days\n* Prior systemic antibiotic therapy within the last 30 days\n* Hospitalization within the last month which included antibacterial therapy\n* The presence of clinically significant hematologic conditions, etc\n* Probenecid treatment'}, 'identificationModule': {'nctId': 'NCT00095368', 'briefTitle': 'APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat', 'organization': {'class': 'INDUSTRY', 'fullName': 'Advancis Pharmaceutical Corporation'}, 'officialTitle': 'A Phase III, Randomized, Double-Blind, Double-Dummy Multicenter Study to Evaluate the Efficacy and Safety of 775 mg APC-111 MP Tablet QD for 7 Days vs Penicillin VK 250 mg QID for 10 Days in Patients With Streptococcus Pyogenes', 'orgStudyIdInfo': {'id': '111.301'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Manford Gooch, MD', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advancis Pharmaceutical Corporation', 'class': 'INDUSTRY'}}}}