Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT00847756
Status:
UNKNOWN
Last Update Posted:
2011-07-20
First Post:
2009-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Host-pathogen Interaction in Otitis Media
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood nasopharyngeal swab middle ear fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-19', 'studyFirstSubmitDate': '2009-02-18', 'studyFirstSubmitQcDate': '2009-02-18', 'lastUpdatePostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of biological markers in blood which inform us about the risk of recurrent infection and severity of disease', 'timeFrame': '01-06-2009 to 01-06-2010'}], 'secondaryOutcomes': [{'measure': 'Otitis media demography', 'timeFrame': '15-04-2008 to 01-01-2010'}, {'measure': 'Bacterial and viral pathogen detection', 'timeFrame': '15-04-2008 to 01-01-2010'}, {'measure': 'Determination of the molecular and cellular immune response in relation to viral and bacterial pathogens', 'timeFrame': '15-04-08 to 01-01-2010'}, {'measure': 'Gene expression profiling of the three major bacterial pathogens: S. pneumoniae, H. influenzae and M. catarrhalis', 'timeFrame': '01-06-2009 to 01-06-2010'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Otitis media', 'demography', 'Streptococcus pneumoniae', 'Haemophilus influenzae', 'Moraxella catarrhalis', 'rhinovirus', 'children, 0-5 years of age', 'diagnosed rAOM, COME or CSOM by an otorhinolaryngologist', 'primary and secondary hospital Nijmegen, the Netherlands'], 'conditions': ['Otitis Media']}, 'descriptionModule': {'briefSummary': 'Otitis Media (OM) is one of the most frequent diseases in childhood and the primary reason for children to visit a physician. In many countries it is the most common reason to prescribe antibiotics leading to increased drug-resistance of the causative agents, or to undergo surgery. Costs for general health care are expanding, and are estimated to be 3-5 billion dollar annually in the United States. Prevention is suspected to be an important solution to this problem.\n\nAlthough OM management has no universal standard yet, it may imply watchful waiting, antibiotic treatment, adenoidectomy, insertion of tympanostomy tubes and (future) vaccination. Approximately 80% of the acute otitis media (AOM) cases is self-limiting within 2-14 days and also otitis media with effusion (OME) resolves spontaneously: 60% of newly detected OME resolves within 3 months. However, in a significant part of the OM population persistent or recurrent episodes of OM are responsible for a significant morbidity for both children and parents, despite variable treatment options.\n\nThrough the set up of a new prospective cohort in a clinical setting, relevant patient characteristics, the role of bacterial and viral pathogens, the role of recurrent infection in relation to biofilm formation, and the host response at protein level will be studied in detail. This project is expected to increase the understanding of the underlying mechanisms of OM disease, which will support future treatment and prevention strategies. Better understanding in OM pathogenesis is warranted in order to develop these novel preventive strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children up to 5 years of age suffering from rAOM, COME or CSOM waiting for tympanostomy tube insertion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children up to 5 years of age\n* suffering from rAOM, COME or CSOM\n* waiting for tympanostomy tube insertion\n* informed consent\n\nExclusion Criteria:\n\n* No informed consent\n* The child has a malignancy, or organ transplantation, or immune deficiency in the medical history\n* The child had recent elective ear surgery (i.e. mastoidectomy, implants \\<2 weeks ago)\n* The child suffers from systemic infectious diseases (i.e. hepatitis, chickenpox)'}, 'identificationModule': {'nctId': 'NCT00847756', 'acronym': 'OMVac', 'briefTitle': 'Host-pathogen Interaction in Otitis Media', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Thorough Clinical Investigation of the Host-pathogen Interaction in Chronic and Recurrent Otitis Media', 'orgStudyIdInfo': {'id': 'OMVac clinical study'}, 'secondaryIdInfos': [{'id': 'EU-FP6', 'type': 'REGISTRY', 'domain': '037653'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'rAOM', 'description': 'Children 0-5 years of age suffering from recurrent acute otitis media and waiting for tympanostomy tube insertion.', 'interventionNames': ['Other: questionnaire', 'Procedure: blood sample', 'Procedure: collection of middle ear fluid', 'Procedure: nasopharyngeal swab']}, {'label': 'COME', 'description': 'Children 0-5 years of age suffering from chronic otitis media with effusion and waiting for tympanostomy tube insertion.', 'interventionNames': ['Other: questionnaire', 'Procedure: blood sample', 'Procedure: collection of middle ear fluid', 'Procedure: nasopharyngeal swab']}, {'label': 'CSOM', 'description': 'Children 0-5 years of age suffering from chronic suppurative otitis media and waiting for tympanostomy tube insertion. Note: Only 3 patients with CSOM were recruited and therefore not suitable for publication.'}], 'interventions': [{'name': 'questionnaire', 'type': 'OTHER', 'description': 'Identification of risk factors', 'armGroupLabels': ['COME', 'rAOM']}, {'name': 'blood sample', 'type': 'PROCEDURE', 'description': 'venal puncture, 5ml. A blood sample will be taken at the day of surgery and after 2-3 months.', 'armGroupLabels': ['COME', 'rAOM']}, {'name': 'collection of middle ear fluid', 'type': 'PROCEDURE', 'description': 'During routine surgery middle ear fluids are collected per patient.', 'armGroupLabels': ['COME', 'rAOM']}, {'name': 'nasopharyngeal swab', 'type': 'PROCEDURE', 'description': 'A nasopharyngeal swab is taken at the end of the surgical procedure and after 2-3 months.', 'armGroupLabels': ['COME', 'rAOM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Canisius Wilhelmina hospital, Department of otorhinolaryngology', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud, University Nijmegen Medical Centre, Department of Otorhinolaryngology', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Ronald de Groot, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands'}, {'name': 'Kim Stol, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. dr. R. de Groot, head department of Pediatrics', 'oldOrganization': 'Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands'}}}}