Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-22 @ 2:29 PM
Study NCT ID:
NCT02098850
Status:
UNKNOWN
Last Update Posted:
2014-12-03
First Post:
2014-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Staphylococcus Aureus Bacteraemia in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-02', 'studyFirstSubmitDate': '2014-03-25', 'studyFirstSubmitQcDate': '2014-03-27', 'lastUpdatePostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '90 Days'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '90 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Staphylococcus aureus', 'bloodstream infection', 'bacteremia'], 'conditions': ['Staphylococcus Aureus Bacteremia']}, 'referencesModule': {'references': [{'pmid': '24247070', 'type': 'BACKGROUND', 'citation': 'Kaasch AJ, Barlow G, Edgeworth JD, Fowler VG Jr, Hellmich M, Hopkins S, Kern WV, Llewelyn MJ, Rieg S, Rodriguez-Bano J, Scarborough M, Seifert H, Soriano A, Tilley R, Torok ME, Weiss V, Wilson AP, Thwaites GE; ISAC, INSTINCT, SABG, UKCIRG, and Colleagues. Staphylococcus aureus bloodstream infection: a pooled analysis of five prospective, observational studies. J Infect. 2014 Mar;68(3):242-51. doi: 10.1016/j.jinf.2013.10.015. Epub 2013 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this evaluation is to record the management and outcome of adults with S.aureus bacteraemia (SAB) across multiple European, Asian and North American sites and to identify key quality indicators associated with improved outcome.', 'detailedDescription': 'Staphylococcus aureus (S. aureus) is one of the most common causes of bloodstream infections. Associated mortality has been reported to vary widely (4%-40%) although no obvious explanation for such variation has been identified.\n\nDespite the existence of clinical guidelines, there is considerable variation in the management of S.aureus bacteraemia (SAB) between centres. Part of the variation in clinical management is due to the limited evidence base defining optimal therapy. Fewer than 1500 patients have been recruited to randomised controlled trials in the past 40 years; practice is therefore based largely on experience and observational studies.\n\nThe purpose of this evaluation is to record the management and outcome of adults with SAB across multiple European, Asian and North American sites. We aim to establish a broader knowledge base, identify key quality indicators associated with improved outcomes, and to provide comparator data to ensure that patients enrolled in randomized controlled trials are representative of bacteraemic S. aureus patients as a whole. All participating centres are experienced in the management of S. aureus bacteraemia and in conducting evaluations of current management practice and outcomes from S. aureus bacteraemia. Data is checked for plausibility by a centralized data quality control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient in tertiary care hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* S. aureus (methicillin sensitive or resistant) isolated from one or more blood cultures\n\nExclusion Criteria:\n\n* Recurrent episodes of S. aureus bloodstream infection\n* Polymicrobial infection'}, 'identificationModule': {'nctId': 'NCT02098850', 'acronym': 'ISAC', 'briefTitle': 'Staphylococcus Aureus Bacteraemia in Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'A Prospective International Study of Staphylococcus Aureus Bacteraemia in Adults by the International Staphylococcus Aureus Collaboration', 'orgStudyIdInfo': {'id': 'ISAC-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '50935', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Achim J Kaasch, MD', 'role': 'CONTACT', 'email': 'achim.kaasch@uk-koeln.de', 'phone': '+4922147832022'}, {'name': 'Achim J Kaasch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uniklinik Koln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Siegbert Rieg, MD', 'role': 'CONTACT'}], 'facility': 'Uniklinik Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '23562', 'city': 'Lübeck', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jan Rupp, MD', 'role': 'CONTACT'}], 'facility': 'Univeritatklinikum Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hong Bin Kim', 'role': 'CONTACT'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08026', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Mercedes Gurgui Ferrer, MD', 'role': 'CONTACT'}], 'facility': 'Hospital San Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08028', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alex Soriano, MD', 'role': 'CONTACT'}], 'facility': 'University Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Benito Almirante, MD', 'role': 'CONTACT'}], 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '79 07120', 'city': 'Palma. Mallorca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose Luis Perez Saenz, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Son Espases'}, {'city': 'Salamanca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Hugo Guillermo Ternavasio-de la Vega, MD', 'role': 'CONTACT'}], 'facility': 'Salamanca Hospital', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'zip': '41007', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jesus Rodriguez-Bano, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41013', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Luis Edwardo Lopez-Cortes, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'New Taipei City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chun-Hsing Liao', 'role': 'CONTACT'}], 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'zip': 'B9 5SS', 'city': 'Birmingham', 'state': 'West Midlands', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Das Pillay, MD', 'role': 'CONTACT'}], 'facility': 'Birmingham Heartlands Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BN2 5BE', 'city': 'Brighton', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Martin Llewelyn, MD', 'role': 'CONTACT'}], 'facility': 'Brighton and Sussex University Hospitals', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Estee Torok, MD', 'role': 'CONTACT'}], 'facility': 'Cambridge University Hospitals', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'HU3 2JZ', 'city': 'Hull', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Gavin Barlow, MD', 'role': 'CONTACT'}], 'facility': 'Hull and East Yorkshire Hospitals', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Emmanuel Nsutebu, MD', 'role': 'CONTACT'}], 'facility': 'Royal Liverpool and Broadgreen Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'NW3 2QG', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Susan Hopkins, MD', 'role': 'CONTACT'}], 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 7EH', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Jonathan Edgeworth, MD', 'role': 'CONTACT'}], 'facility': "Guy's and St Thomas'", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Dakshika Jeyaratnam, MD', 'role': 'CONTACT'}], 'facility': 'Kings College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC1E 6AG', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Peter Wilson, MD', 'role': 'CONTACT'}], 'facility': 'University College London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Matthew Scarborough, MD', 'role': 'CONTACT'}], 'facility': 'Oxford University Hospitals', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Robert Tilley, MD', 'role': 'CONTACT'}], 'facility': 'Plymouth Hospitals', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'PO3 6AD', 'city': 'Portsmouth', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Sarah Wyllie, MD', 'role': 'CONTACT'}], 'facility': 'Portsmouth Hospitals', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}], 'centralContacts': [{'name': 'Achim J Kaasch, MD', 'role': 'CONTACT', 'phone': '+4922147832100'}, {'name': 'Christian M Bernasch', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Achim J Kaasch, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Cologne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Achim Kaasch', 'investigatorFullName': 'Achim Kaasch', 'investigatorAffiliation': 'University of Cologne'}}}}