Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 2:46 PM
Study NCT ID:
NCT04321733
Status:
UNKNOWN
Last Update Posted:
2020-03-25
First Post:
2020-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bacteriological Study of Acute Follicular Tonsillitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sensitivity of the isolated organism to amoxicillin clavulanate according to culture and sensitivity test', 'timeFrame': 'Baseline', 'description': 'throat swabs that will be taken from the tonsillar exudate, placed in sterile bottles and brought to the laboratory for Bacteriological culture of the organism and Antibiotic sensitivity tests will be done for the isolated organism(s).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Follicular Tonsillitis']}, 'referencesModule': {'references': [{'pmid': '17644191', 'type': 'BACKGROUND', 'citation': 'Brook I. Overcoming penicillin failures in the treatment of Group A streptococcal pharyngo-tonsillitis. Int J Pediatr Otorhinolaryngol. 2007 Oct;71(10):1501-8. doi: 10.1016/j.ijporl.2007.06.006. Epub 2007 Jul 17.'}, {'pmid': '17292576', 'type': 'BACKGROUND', 'citation': 'Casey JR, Pichichero ME. The evidence base for cephalosporin superiority over penicillin in streptococcal pharyngitis. Diagn Microbiol Infect Dis. 2007 Mar;57(3 Suppl):39S-45S. doi: 10.1016/j.diagmicrobio.2006.12.020. Epub 2007 Feb 9.'}, {'pmid': '10574501', 'type': 'BACKGROUND', 'citation': 'Sela S, Barzilai A. Why do we fail with penicillin in the treatment of group A streptococcus infections? Ann Med. 1999 Oct;31(5):303-7. doi: 10.3109/07853899908995895.'}], 'seeAlsoLinks': [{'url': 'http://www.researchgate.net/publication/285386865_Clinical_and_Bacteriological_Study_of_Acute_Tonsillitis', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to answer the following questions :-\n\n1. Is there an actual failure rate in tonsillitis treatment with amoxicillin clavulanate ? If yes,\n2. What is (are) the possible reason(s) to explain it in our locality ?', 'detailedDescription': 'Tonsillitis is one of the most common diseases in the throat that occurs in the younger age group .\n\nThe predominant bacteria causing tonsillitis are group A b-haemolytic streptococci (GABHS), which are highly susceptible to the penicillin group of antibiotics.\n\nIt has been reported in the literature that the rate of penicillin failure has consistently increased from about 7% in the 1950s to almost 40% in the 2000s.\n\nAuthors propose many reasons to explain such failure rates e.g. the coexistence of oropharyngeal beta-lactamase producing bacteria .\n\nAlthough there were no documented reports, it was observed that there are rising reports of failure in treatment of acute follicular tonsillitis by amoxicillin clavulanate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute follicular tonsillitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\npatients with acute follicular tonsillitis neither younger than five years nor older than 60 years old.\n\nExclusion Criteria:\n\n1. Other causes of tonsillitis that do not cause suppuration .\n2. Age below five , and above 60 years .\n3. Patients who received antibiotic one week before presentation .\n4. Immune compromised patients .\n5. Patients with quinsy.'}, 'identificationModule': {'nctId': 'NCT04321733', 'briefTitle': 'Bacteriological Study of Acute Follicular Tonsillitis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Bacteriological Study of Acute Follicular Tonsillitis in Patients Attending the ENT Outpatient Clinic of Assiut University Hospital', 'orgStudyIdInfo': {'id': 'Bacteriology of Tonsillitis'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Amoxicillin Clavulanate', 'type': 'DRUG', 'description': 'Intravenous drug intake of our drug.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mena W Dous, Principal investigator', 'role': 'CONTACT', 'email': 'Dr_manoon@hotmail.com', 'phone': '+201277170022'}, {'name': 'Alaa K Abd El Haleem, Professor of Otolaryngology', 'role': 'CONTACT', 'phone': '+201005534200'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mena Wahby Dous Hana', 'investigatorAffiliation': 'Assiut University'}}}}