Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-21 @ 7:08 AM
Study NCT ID:
NCT01821456
Status:
RECRUITING
Last Update Posted:
2013-04-01
First Post:
2013-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cologne Cohort of Neutropenic Patients (CoCoNut)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009503', 'term': 'Neutropenia'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D000935', 'term': 'Antifungal Agents'}, {'id': 'D000998', 'term': 'Antiviral Agents'}], 'ancestors': [{'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '1995-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2050-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-26', 'studyFirstSubmitDate': '2013-03-19', 'studyFirstSubmitQcDate': '2013-03-26', 'lastUpdatePostDateStruct': {'date': '2013-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2050-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term survival of hematology and oncology patients following neutropenia', 'timeFrame': '2 years following last follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hematological malignancies', 'cancer', 'chemotherapy', 'anti-infectives', 'treatment', 'outcome'], 'conditions': ['Hematological Malignancies', 'Cancer', 'Chemotherapy', 'Neutropenia', 'Immunosuppression']}, 'referencesModule': {'references': [{'pmid': '20410061', 'type': 'RESULT', 'citation': 'Vehreschild JJ, Ruping MJ, Wisplinghoff H, Farowski F, Steinbach A, Sims R, Stollorz A, Kreuzer KA, Hallek M, Bangard C, Cornely OA. Clinical effectiveness of posaconazole prophylaxis in patients with acute myelogenous leukaemia (AML): a 6 year experience of the Cologne AML cohort. J Antimicrob Chemother. 2010 Jul;65(7):1466-71. doi: 10.1093/jac/dkq121. Epub 2010 Apr 21.'}, {'pmid': '24798021', 'type': 'DERIVED', 'citation': 'Vehreschild MJ, von Bergwelt-Baildon M, Tran L, Shimabukuro-Vornhagen A, Wisplinghoff H, Bangard C, Cornely OA, Vehreschild JJ. Feasibility and effectiveness of posaconazole prophylaxis in combination with micafungin bridging for patients undergoing allogeneic stem cell transplantation: a 6-yr analysis from the cologne cohort for neutropenic patients. Eur J Haematol. 2014 Nov;93(5):400-6. doi: 10.1111/ejh.12368. Epub 2014 May 26.'}, {'pmid': '24607558', 'type': 'DERIVED', 'citation': 'Vehreschild MJ, Weitershagen D, Biehl LM, Tacke D, Waldschmidt D, Tox U, Wisplinghoff H, Von Bergwelt-Baildon M, Cornely OA, Vehreschild JJ. Clostridium difficile infection in patients with acute myelogenous leukemia and in patients undergoing allogeneic stem cell transplantation: epidemiology and risk factor analysis. Biol Blood Marrow Transplant. 2014 Jun;20(6):823-8. doi: 10.1016/j.bbmt.2014.02.022. Epub 2014 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'The Cologne Cohort of Neutropenic Patients (CoCoNut) is a non-interventional cohort study assessing risk factors, interventions, and outcome of immunosuppressed patients with or without opportunistic infections.', 'detailedDescription': 'This prospective cohort was established with the aim of a comprehensive data collection of all patients developing neutropenia after receiving chemotherapy for any kind of malignant disease, treated in the University Hospital of Cologne.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients developing neutropenia after receiving chemotherapy for any kind of malignant disease, treated in the University Hospital of Cologne', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* immunosuppressed patients\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01821456', 'acronym': 'CoCoNut', 'briefTitle': 'Cologne Cohort of Neutropenic Patients (CoCoNut)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Cologne'}, 'officialTitle': 'The Cologne Cohort of Neutropenic Patients (CoCoNut) - a Non-interventional Cohort Study Assessing Risk Factors, Interventions, and Outcome of Immunosuppressed Patients With or Without Opportunistic Infections', 'orgStudyIdInfo': {'id': '!SZINF2'}, 'secondaryIdInfos': [{'id': '!!SZINF2', 'type': 'OTHER', 'domain': 'University Hospital of Cologne'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Antiinfectives', 'description': 'To analyze the efficacy of antiinfectives at high risk patients', 'interventionNames': ['Drug: Antiinfectives']}], 'interventions': [{'name': 'Antiinfectives', 'type': 'DRUG', 'otherNames': ['Antifungals, Antibacterials, Antivirals'], 'description': 'To analyze to efficacy of (novel) drug therapies', 'armGroupLabels': ['Antiinfectives']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50924', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jörg Janne Vehreschild, Dr. med.', 'role': 'CONTACT', 'email': 'janne.vehreschild@ctuc.de', 'phone': '+0049 (0)221 478-6494', 'phoneExt': '-6494'}, {'name': 'Oliver Andreas Cornely, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'oliver.cornely@ctuc.de', 'phone': '0049 (0)221 478-6494', 'phoneExt': '-6494'}, {'name': 'Jörg J. Vehreschild, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}