Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 6:22 PM
Study NCT ID:
NCT04807660
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2021-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bacteriological Evaluation of Children With Otorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2021-03-18', 'studyFirstSubmitQcDate': '2021-03-18', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacteria identification', 'timeFrame': 'at inclusion', 'description': 'The percentage of children with otopathogens'}], 'secondaryOutcomes': [{'measure': 'Describe the serotypes of S. pneumoniae', 'timeFrame': 'at inclusion', 'description': 'percentage of each serotype'}, {'measure': 'Describe the resistance of heamophilus influenzae', 'timeFrame': 'at inclusion', 'description': 'percentage of resistant h. inlfuenzae'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['otorrrhea', 'children', 'spontaneous perforation of the tympanic membrane', 'ambulatory', 'streptococcus pneumoniae', 'heamophilus influenzae', 'moraxella catarrhalis', 'streptococcus pyogenes'], 'conditions': ['Otorrhea']}, 'referencesModule': {'references': [{'pmid': '37368992', 'type': 'DERIVED', 'citation': 'Cohen R, Varon E, Bidet P, Cohen JF, Bechet S, Couloigner V, Michot AS, Guiheneuf C, Bonacorsi S, Levy C. Diagnostic Accuracy of Group A Streptococcus Rapid Antigen Detection Test on Middle Ear Fluid in Children With Acute Otitis Media With Spontaneous Perforation: A Prospective Multicenter Evaluation. Pediatr Infect Dis J. 2023 Sep 1;42(9):816-818. doi: 10.1097/INF.0000000000004009. Epub 2023 Jun 22.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/30707730/', 'label': 'Bacterial causes of otitis media with spontaneous perforation of the tympanic membrane in the era of 13 valent pneumococcal conjugate vaccine'}]}, 'descriptionModule': {'briefSummary': 'After pneumococcal conjugate vaccine implementation, the number of acute otitis media (AOM) episodes has decreased, but AOM still remains among the most common diagnoses in childhood. From 2% to 17% of cases of AOM feature spontaneous perforation of the tympanic membrane (SPTM). The aim of this study was to describe the bacteriological causes of SPTM several years after PCV13 implementation, in 2010.', 'detailedDescription': 'Since October 2015, children with spontaneous perforation of the tympanic membrane (SPTM) are prospectively enrolled by 41 pediatricians who are part of a research and teaching network (ACTIV, Association Clinique et Thérapeutique Infantile du Val de Marne \\[Clinical and Therapeutic Association of Val de Marne\\]) throughout France. For some patients, otorrhea is the first manifestation of AOM; for others, otorrhea occurred after AOM treatment failure or recurrence. Failure (non-responsive AOM) is defined as otorrhea appearing despite at least 48 hr of antibiotics or recurring less than 4 days after the end of antibiotic treatment. Recurrence is defined by the appearance of otorrhea 4 to 30 days after the end of antibiotic treatment for AOM.\n\nMiddle ear fluid (MEF) is obtained by sampling spontaneous discharge according to clinical practice guidelines. MEF specimens are obtained with cotton-tipped wire swabs, immediately placed in transport medium (Copan Venturi Transystem®, Brescia, Italy), and transported within 48 hr to one of the two centralized microbiology laboratories (Robert Debré Hospital or National Centre for Pneumococci at European Georges Pompidou Hospital, Paris, France).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all children from 3 months to 15 years old with otorrhea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children from 3 months to 15 years old\n* with otorrhea\n* signed parents consent\n\nExclusion Criteria:\n\n* children under 3 months\n* children \\> 15 years old'}, 'identificationModule': {'nctId': 'NCT04807660', 'briefTitle': 'Bacteriological Evaluation of Children With Otorrhea', 'organization': {'class': 'OTHER', 'fullName': 'Association Clinique Thérapeutique Infantile du val de Marne'}, 'officialTitle': 'Bacteriological Evaluation of Spontaneous Otorrhea in Children', 'orgStudyIdInfo': {'id': 'ACT0315'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective cohort', 'description': 'Middle ear fluid sample for each enrrolled children', 'interventionNames': ['Other: middle ear fluid sample']}], 'interventions': [{'name': 'middle ear fluid sample', 'type': 'OTHER', 'description': 'middle ear fluid sample for each enrrolled children', 'armGroupLabels': ['Prospective cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Corinne Levy, MD', 'role': 'CONTACT', 'email': 'corinne.levy@activ-france.fr', 'phone': '0033148850404'}, {'name': 'Stéphane Béchet, MSc', 'role': 'CONTACT', 'email': 'stephane.bechet@activ-france.fr', 'phone': '0033148850404'}], 'facility': 'ACTIV', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'centralContacts': [{'name': 'Corinne Levy, MD', 'role': 'CONTACT', 'email': 'corinne.levy@activ-france.fr', 'phone': '0033148850404'}, {'name': 'Stéphane Béchet, MSc', 'role': 'CONTACT', 'email': 'sgtephane.bechet@activ-france.fr', 'phone': '0033148850404'}], 'overallOfficials': [{'name': 'Robert Cohen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Association Clinique et Thérapeutique Infantile du Val de Marne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association Clinique Thérapeutique Infantile du val de Marne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}