Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT00456469
Status:
UNKNOWN
Last Update Posted:
2007-04-05
First Post:
2007-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnosis of Active and Latent TB Infection With IFN-y Assays in African Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-04-04', 'studyFirstSubmitDate': '2007-04-04', 'studyFirstSubmitQcDate': '2007-04-04', 'lastUpdatePostDateStruct': {'date': '2007-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-05', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['TB', 'latent', 'infection', 'Ethiopia'], 'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '22997219', 'type': 'DERIVED', 'citation': 'Yassin MA, Petrucci R, Garie KT, Harper G, Teshome A, Arbide I, Asnake G, Ahmed HJ, Mammo T, Yesuf K, Cuevas LE. Use of tuberculin skin test, IFN-gamma release assays and IFN-gamma-induced protein-10 to identify children with TB infection. Eur Respir J. 2013 Mar;41(3):644-8. doi: 10.1183/09031936.00012212. Epub 2012 Sep 20.'}, {'pmid': '22069451', 'type': 'DERIVED', 'citation': 'Garie KT, Yassin MA, Cuevas LE. Lack of adherence to isoniazid chemoprophylaxis in children in contact with adults with tuberculosis in Southern Ethiopia. PLoS One. 2011;6(11):e26452. doi: 10.1371/journal.pone.0026452. Epub 2011 Nov 1.'}, {'pmid': '21966356', 'type': 'DERIVED', 'citation': 'Yassin MA, Petrucci R, Garie KT, Harper G, Arbide I, Aschalew M, Merid Y, Kebede Z, Bawazir AA, Abuamer NM, Cuevas LE. Can interferon-gamma or interferon-gamma-induced-protein-10 differentiate tuberculosis infection and disease in children of high endemic areas? PLoS One. 2011;6(9):e23733. doi: 10.1371/journal.pone.0023733. Epub 2011 Sep 23.'}]}, 'descriptionModule': {'briefSummary': 'Study based in Southern Ethiopia Purpose - to explore if children in contact with adults with TB have positive acute reactants such as IFN-y and other cytokine responses; if these responses discriminate between high and low risk of disease progression and whether these could be incorporated into improved diagnostic approaches.', 'detailedDescription': 'The study follows children in contact with TB. Those with positive TST will be offered chemoprophylaxis and all children will be followed for 2 years to describe IFN-y responses over time, identify symptoms of active TB and if these symptoms are associated with IFN-y and other cytokine responses.\n\nChildren with suspicion of TB attending health centres will also be investigated using routine diagnostic tests and IFN-y and other cytokines responses to evaluate if the latter could be used in improved diagnostic approaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Children - 1 to 14 years old in contact with adults with smear positive TB\n\nOr:\n\n\\- Children with suspicion of TB admitted to the hospital for investigations\n\nExclusion Criteria:\n\n\\- Residency \\> 10 Km from recruitment center\n\nOr:\n\n\\- Patient severely to undergo diagnostic procedures.'}, 'identificationModule': {'nctId': 'NCT00456469', 'acronym': 'ALTAC', 'briefTitle': 'Diagnosis of Active and Latent TB Infection With IFN-y Assays in African Children', 'organization': {'class': 'OTHER', 'fullName': 'Liverpool School of Tropical Medicine'}, 'officialTitle': 'Diagnosis of Active and Latent TB Infection With IFN-y Assays in African Children', 'orgStudyIdInfo': {'id': '06.49 TF Cuevas'}}, 'contactsLocationsModule': {'locations': [{'zip': '12', 'city': 'Awasa', 'state': 'Southern Region', 'country': 'Ethiopia', 'contacts': [{'name': 'Mohammed Yassin, Dr', 'role': 'CONTACT'}, {'name': 'Mohammed Yassin, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Bushullo Major Health Centre', 'geoPoint': {'lat': 7.06205, 'lon': 38.47635}}], 'centralContacts': [{'name': 'Luis Cuevas, MD MTropMed', 'role': 'CONTACT', 'email': 'lcuevas@liv.ac.uk', 'phone': '0151 705 3219'}], 'overallOfficials': [{'name': 'Luis Cuevas, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liverpool School of Tropical Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liverpool School of Tropical Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Thrasher Research Fund', 'class': 'OTHER'}]}}}