Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-02-25 @ 11:13 PM
Study NCT ID:
NCT02786693
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2016-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Diagnosis of Fever and Biologic Inflammatory Syndrome of Unknown Origin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005335', 'term': 'Fever of Unknown Origin'}], 'ancestors': [{'id': 'D005334', 'term': 'Fever'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2016-01-08', 'studyFirstSubmitQcDate': '2016-05-25', 'lastUpdatePostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of a final diagnosis after paraclinical explorations', 'timeFrame': '1 year', 'description': 'Final diagnosis according to the previous classification : infectious disease, inflammatory or auto-immune disease, cancer, or miscellaneous cause.'}], 'secondaryOutcomes': [{'measure': 'prevalence of FUO/SII :', 'timeFrame': '1 year', 'description': 'Number of patients with FUO and SII, assessed by inclusion in the present study .'}, {'measure': 'causes of FUO/SII: Proportion of each causes of FUO/SII, according to the main outcome after final diagnosis', 'timeFrame': '1 year', 'description': '5 possible causes : infectious diseases, auto-immune and inflammatory diseases, cancers, miscellaneous causes.\n\nFinal diagnosis is determined according to the usual criteria, reviewed by two practitioners.'}, {'measure': 'Mortality rate of patient with FUO and SII, according to the presence or absence of a final diagnosis', 'timeFrame': '1 year', 'description': 'mortality rate'}, {'measure': 'Medical economic evaluation of the utility of the TEP scan in the diagnostic approach', 'timeFrame': '1 year', 'description': 'Benefit of TEP Scan in the diagnosis of FUO and SII : The utility is defined as an examination which allows :\n\n* the direct diagnosis or\n* direct the examination which will allow the diagnosis. The utility will be validated for every examination by 2 responsible doctors'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['TEP-scan'], 'conditions': ['Fever of Unknown Origin']}, 'referencesModule': {'references': [{'pmid': '13734791', 'type': 'BACKGROUND', 'citation': 'PETERSDORF RG, BEESON PB. Fever of unexplained origin: report on 100 cases. Medicine (Baltimore). 1961 Feb;40:1-30. doi: 10.1097/00005792-196102000-00001. No abstract available.'}, {'pmid': '1651090', 'type': 'BACKGROUND', 'citation': 'Durack DT, Street AC. Fever of unknown origin--reexamined and redefined. Curr Clin Top Infect Dis. 1991;11:35-51. No abstract available.'}, {'pmid': '12603493', 'type': 'BACKGROUND', 'citation': 'Knockaert DC, Vanderschueren S, Blockmans D. Fever of unknown origin in adults: 40 years on. J Intern Med. 2003 Mar;253(3):263-75. doi: 10.1046/j.1365-2796.2003.01120.x.'}, {'pmid': '17220753', 'type': 'BACKGROUND', 'citation': 'Bleeker-Rovers CP, Vos FJ, de Kleijn EMHA, Mudde AH, Dofferhoff TSM, Richter C, Smilde TJ, Krabbe PFM, Oyen WJG, van der Meer JWM. A prospective multicenter study on fever of unknown origin: the yield of a structured diagnostic protocol. Medicine (Baltimore). 2007 Jan;86(1):26-38. doi: 10.1097/MD.0b013e31802fe858.'}, {'pmid': '17629532', 'type': 'BACKGROUND', 'citation': 'Kucukardali Y, Oncul O, Cavuslu S, Danaci M, Calangu S, Erdem H, Topcu AW, Adibelli Z, Akova M, Karaali EA, Ozel AM, Bolaman Z, Caka B, Cetin B, Coban E, Karabay O, Karakoc C, Karan MA, Korkmaz S, Sahin GO, Pahsa A, Sirmatel F, Solmazgul E, Ozmen N, Tokatli I, Uzun C, Yakupoglu G, Besirbellioglu BA, Gul HC; Fever of Unknown Origin Study Group. The spectrum of diseases causing fever of unknown origin in Turkey: a multicenter study. Int J Infect Dis. 2008 Jan;12(1):71-9. doi: 10.1016/j.ijid.2007.04.013. Epub 2007 Jul 12.'}], 'seeAlsoLinks': [{'url': 'http://www.chu-grenoble.fr', 'label': 'university hospital Grenoble website'}]}, 'descriptionModule': {'briefSummary': 'Fever of unknown origin (FUO) and biologic inflammatory syndrome of unknown origin (SII) are two frequent causes of hospitalization or consultation in infectious disease unit and internal medicine.\n\nThere are many etiologies, in four categories: infections, auto-immune disease, cancer and miscellaneous causes. Currently there is no specifics recommendations to follow a "diagnosis way" of FUO and SII.\n\nPurpose: Evaluation of clinical practices in the diagnosis of fever and biologic inflammatory syndrome of unknown origin, in two units of the University Grenoble Hospital.', 'detailedDescription': 'Fever of unknown origin (FUO) and biologic inflammatory syndrome of unknown origin (SII) are two frequent causes of hospitalization or consultation in infectious disease unit and internal medicine unit.\n\nThe initial definition for FUO was proposed by Petersdorf and Beeson in 1961 : "fever \\> 38,3°C, permanent or recurrent, for more than 3 weeks, without diagnosis after one week hospitalisation and explorations". This definition has been updated by Durack and Street in 1991 who distinguish "classics FUO" from 3 other categories : nosocomial, patient with HIV and neutropenia. They also choose an other way of diagnosis : 3 days of investigations in hospital OR in consultation.\n\nFinally, Knokaert and al. proposed a new definition, based on a qualitative criterion: No diagnosis after a first step and complete clinical and paraclinical check up.\n\nThe evolution of FUO\'s prevalence is not describe so much. There are many etiologies, classified in four categories: infections, auto-immune disease, cancer and miscellaneous causes. The distribution of FUO\'s causes may change according to geographical localisation, and seems to evolve over time, with apparition of new infectious and inflammatory diseases, and the advent of new diagnosis tools.\n\nCurrently there is no specifics recommendations to follow a "diagnosis way" of FUO and SII. It starts with a complete physical examination and some first lign further exams. Without diagnosis, paraclinical explorations are continued with more specific exams, according to the presence or the absence of diagnosis clues.\n\nThe TEP scanner has shown a great value in the diagnosis of FUO, and trend to be more performed.\n\nInvestigators propose to evaluate professional practices in the diagnosis of fever and biologic inflammatory syndrome of unknown origin, and especially the interest of TEP Scan, in two units of the University Grenoble Hospital.\n\nInvestigators will study prevalence of FUO and SII, and of each causes of FUO and SII, and the prognosis of patients with FUO and SII, according to the presence or the absence of final diagnosis, as well as the economic impact of the different complementary exams.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient with fever and biologic inflammatory syndrome of unknown origin for more than a week', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients \\> 18 years old\n* with fever\\> 38.5°C and/or CRP\\> 5mg/L for more than a week\n* with standard check-up that did not allow a causal diagnosis\n\nExclusion Criteria:\n\n* immunosuppression : HIV, neutropenia, known cancer with chemotherapy, immunosuppressive treatment or corticotherapy (\\> 10mg/L for \\>3 weeks)\n* nosocomial fever\n* pregnant women\n* patients who are not able to sign a consent'}, 'identificationModule': {'nctId': 'NCT02786693', 'acronym': 'FUO', 'briefTitle': 'Evaluation of Diagnosis of Fever and Biologic Inflammatory Syndrome of Unknown Origin', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Evaluation of Diagnosis of Fever and Biologic Inflammatory Syndrome of Unknown Origin', 'orgStudyIdInfo': {'id': '2015-A01627-42'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FUO and SII patients', 'description': 'Patients with fever \\> 38,3°C for more than a week, OR CRP\\> 5mg/L, without diagnosis after a first step clinical examination and paraclinical exams.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Laurence Bouillet, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}