Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-03 @ 6:18 AM
Study NCT ID:
NCT01747369
Status:
UNKNOWN
Last Update Posted:
2017-03-06
First Post:
2011-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surveillance of Hospitalised Pneumonia and Bacterial Meningitis in Tône District, Togo, 2010-2013
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018410', 'term': 'Pneumonia, Bacterial'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D016920', 'term': 'Meningitis, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, cerebro-spinal fluid, nasal aspirate'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-03', 'studyFirstSubmitDate': '2011-07-04', 'studyFirstSubmitQcDate': '2012-12-10', 'lastUpdatePostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of pneumococcal pneumonia requiring hospitalisation, confirmed by blood culture or PCR analysis of blood', 'timeFrame': 'Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)'}, {'measure': 'Incidence of pneumococcal meningitis, confirmed by culture or PCR on cerebro-spinal fluid', 'timeFrame': 'Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)'}], 'secondaryOutcomes': [{'measure': 'Incidence of radiologically confirmed pneumonia requiring hospitalisation', 'timeFrame': 'Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)'}, {'measure': 'Incidence of suspected pneumonia requiring hospitalisation with elevated C-reactive protein serum concentration (<40mg/l)', 'timeFrame': 'Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)'}, {'measure': 'Incidence of suspected pneumonia requiring hospitalisation with reduced oxygen saturation (<90%)', 'timeFrame': 'Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)'}, {'measure': 'Incidence of pneumonia of other bacterial or viral etiology requiring hospitalisation', 'timeFrame': 'Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)'}, {'measure': 'Incidence of acute meningitis of other bacterial etiology', 'timeFrame': 'Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['surveillance study', 'prospective', 'observational', 'health center-based', 'pneumonia, bacterial', 'pneumonia, viral', 'meningitis, bacterial', 'Africa south of the Sahara'], 'conditions': ['Pneumonia, Bacterial', 'Pneumonia, Viral', 'Meningitis, Bacterial']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to estimate the burden of disease due to pneumococci, other bacteria and viruses in the African meningitis belt prior to pneumococcal conjugate vaccine introduction and to estimate the population impact of the vaccine after its implementation in 2014. In a defined population of a sanitary district in northern Togo, during the period 2010 to 2017, investigators enroll patients of all ages with suspected pneumonia requiring hospitalization or suspected bacterial meningitis. Patients are evaluated by bacteriology and molecular biology techniques on blood, cerebro-spinal fluid, nasal aspirates and by chest X-ray.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pneumonia surveillance:\n\n-residents of Tône sanitary district requiring hospitaliation for suspected pneumonia and presenting at one of the hospitals of Dapaong town (district capital)\n\nMeningitis surveillance:\n\n\\- residents fo Tône sanitary district presenting with suspected meningitis at one of the hospitals of Dapaong town (district capital) or Sinkasse health center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Pneumonia surveillance:\n\nInclusion Criteria:\n\n* resident of Tône sanitary district - requiring hospitalisation for at least one night for clinical pneumonia syndrome\n* hospitalised in a study site during the study period\n\nExclusion Criteria:\n\n* absence of informed consent by patient or legal tutor\n\nMeningitis surveillance:\n\nInclusion Criteria:\n\n* resident of Tône sanitary district\n* presenting clinical signs of acute bacterial meningitis\n* hospitalised in a study site during the study period\n\nExclusion Criteria:\n\n* absence of informed consent by patient or legal tutor'}, 'identificationModule': {'nctId': 'NCT01747369', 'briefTitle': 'Surveillance of Hospitalised Pneumonia and Bacterial Meningitis in Tône District, Togo, 2010-2013', 'organization': {'class': 'OTHER', 'fullName': 'Agence de Médecine Préventive, France'}, 'orgStudyIdInfo': {'id': 'PneumoTone'}}, 'contactsLocationsModule': {'locations': [{'city': 'Dapaong', 'state': 'Savanes', 'status': 'RECRUITING', 'country': 'Togo', 'facility': 'Centre Hospitalier Régional (CHR) Savanes', 'geoPoint': {'lat': 10.86225, 'lon': 0.20762}}, {'city': 'Dapaong', 'state': 'Savanes', 'status': 'RECRUITING', 'country': 'Togo', 'facility': "Clinique Win' Pang", 'geoPoint': {'lat': 10.86225, 'lon': 0.20762}}, {'city': 'Dapaong', 'state': 'Savanes', 'status': 'RECRUITING', 'country': 'Togo', 'facility': "Hôpital d'enfants Yendubé", 'geoPoint': {'lat': 10.86225, 'lon': 0.20762}}, {'city': 'Dapaong', 'state': 'Savanes', 'status': 'RECRUITING', 'country': 'Togo', 'facility': 'Polyclinique', 'geoPoint': {'lat': 10.86225, 'lon': 0.20762}}, {'city': 'Sinkassé', 'state': 'Savanes', 'status': 'RECRUITING', 'country': 'Togo', 'facility': 'Centre médico-social (CMS)', 'geoPoint': {'lat': 11.10389, 'lon': 0.00944}}], 'centralContacts': [{'name': 'Makawa-Sy Makawa, MD', 'role': 'CONTACT', 'email': 'makmaksy@yahoo.fr', 'phone': '+228-921 29 31'}, {'name': 'Haoua Tall, PharmD MPH', 'role': 'CONTACT', 'email': 'htall@aamp.org', 'phone': '+226-50300406'}], 'overallOfficials': [{'name': 'Jennifer C Moïsi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Agence de Médecine Préventive'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Agence de Médecine Préventive, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Sanitaire des Savanes, Togo', 'class': 'UNKNOWN'}, {'name': 'Ministere de la Sante et de la Promotion Sociale, Togo', 'class': 'UNKNOWN'}, {'name': "Institut National d'Hygiene, Togo", 'class': 'UNKNOWN'}, {'name': 'Centre Muraz', 'class': 'OTHER'}, {'name': 'Fondation Mérieux, France', 'class': 'UNKNOWN'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}