Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-23 @ 9:23 PM
Study NCT ID:
NCT02979951
Status:
RECRUITING
Last Update Posted:
2024-10-01
First Post:
2016-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fosfomycin I.v. for Treatment of Severely Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D010019', 'term': 'Osteomyelitis'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D016920', 'term': 'Meningitis, Bacterial'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001922', 'term': 'Brain Abscess'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D018410', 'term': 'Pneumonia, Bacterial'}, {'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D018461', 'term': 'Soft Tissue Infections'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D004697', 'term': 'Endocarditis, Bacterial'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'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'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D000038', 'term': 'Abscess'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D053821', 'term': 'Cardiovascular Infections'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D004696', 'term': 'Endocarditis'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2016-11-24', 'studyFirstSubmitQcDate': '2016-12-01', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with clinical success as defined as clinical cure or clinical improvement', 'timeFrame': 'Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)', 'description': 'Definition of clinical cure (both criteria must be fulfilled):\n\n* Resolution of signs and symptoms and\n* microbiological cure or no additional antibiotic therapy for the targeted infection necessary.\n\nDefinition of clinical improvement (both criteria must be fulfilled):\n\n* Partial resolution of signs and symptoms and\n* microbiological cure or no additional antibiotic therapy for the targeted infection necessary.\n\nDefinition of microbiological cure:\n\n* Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or\n* in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.\n\nTime Frame:\n\nTime point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).'}], 'secondaryOutcomes': [{'measure': 'Microbiological cure', 'timeFrame': 'Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)', 'description': 'Definition of microbiological cure:\n\n* Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or\n* in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.\n\nTime Frame:\n\nTime point "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.'}, {'measure': 'Microbiological cure', 'timeFrame': 'Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)', 'description': 'Definition of microbiological cure:\n\n* Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or\n* in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.\n\nTime Frame:\n\nTime point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).'}, {'measure': 'Microbiological cure', 'timeFrame': 'Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)', 'description': 'Definition of microbiological cure:\n\n* Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or\n* in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.\n\nTime Frame:\n\nTime point "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.'}, {'measure': 'Microbiological cure', 'timeFrame': 'Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")', 'description': 'Definition of microbiological cure:\n\n* Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or\n* in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.\n\nTime Frame:\n\nDefined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.'}, {'measure': 'Clinical success as defined as clinical cure or clinical improvement', 'timeFrame': 'Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)', 'description': 'Definition of clinical cure (both criteria must be fulfilled):\n\n* Resolution of signs and symptoms and\n* microbiological cure or no additional antibiotic therapy for the targeted infection necessary.\n\nDefinition of clinical improvement (both criteria must be fulfilled):\n\n* Partial resolution of signs and symptoms and\n* microbiological cure or no additional antibiotic therapy for the targeted infection necessary.\n\nDefinition of microbiological cure:\n\n* Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or\n* in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.\n\nTime Frame:\n\nTime point "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.'}, {'measure': 'Clinical success as defined as clinical cure or clinical improvement', 'timeFrame': 'Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)', 'description': 'Definition of clinical cure (both criteria must be fulfilled):\n\n* Resolution of signs and symptoms and\n* microbiological cure or no additional antibiotic therapy for the targeted infection necessary.\n\nDefinition of clinical improvement (both criteria must be fulfilled):\n\n* Partial resolution of signs and symptoms and\n* microbiological cure or no additional antibiotic therapy for the targeted infection necessary.\n\nDefinition of microbiological cure:\n\n* Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or\n* in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.\n\nTime Frame:\n\nTime point "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.'}, {'measure': 'Clinical success as defined as clinical cure or clinical improvement', 'timeFrame': 'Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")', 'description': 'Definition of clinical cure (both criteria must be fulfilled):\n\n* Resolution of signs and symptoms and\n* microbiological cure or no additional antibiotic therapy for the targeted infection necessary.\n\nDefinition of clinical improvement (both criteria must be fulfilled):\n\n* Partial resolution of signs and symptoms and\n* microbiological cure or no additional antibiotic therapy for the targeted infection necessary.\n\nDefinition of microbiological cure:\n\n* Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or\n* in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.\n\nTime Frame:\n\nDefined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.'}, {'measure': 'Clinical cure', 'timeFrame': 'Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)', 'description': 'Definition of clinical cure (both criteria must be fulfilled):\n\n* Resolution of signs and symptoms and\n* microbiological cure or no additional antibiotic therapy for the targeted infection necessary.\n\nDefinition of microbiological cure:\n\n* Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or\n* in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.\n\nTime Frame:\n\nTime point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).'}, {'measure': 'Clinical cure', 'timeFrame': 'Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)', 'description': 'Definition of clinical cure (both criteria must be fulfilled):\n\n* Resolution of signs and symptoms and\n* microbiological cure or no additional antibiotic therapy for the targeted infection necessary.\n\nDefinition of microbiological cure:\n\n* Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or\n* in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.\n\nTime Frame:\n\nTime point "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.'}, {'measure': 'Clinical cure', 'timeFrame': 'Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")', 'description': 'Definition of clinical cure (both criteria must be fulfilled):\n\n* Resolution of signs and symptoms and\n* microbiological cure or no additional antibiotic therapy for the targeted infection necessary.\n\nDefinition of microbiological cure:\n\n* Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or\n* in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.\n\nTime Frame:\n\nDefined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.'}, {'measure': 'Clinical improvement', 'timeFrame': 'Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)', 'description': 'Definition of clinical improvement (both criteria must be fulfilled):\n\n* Partial resolution of signs and symptoms and\n* microbiological cure or no additional antibiotic therapy for the targeted infection necessary.\n\nDefinition of microbiological cure:\n\n* Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or\n* in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.\n\nTime Frame:\n\nTime point "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.'}, {'measure': 'Clinical improvement', 'timeFrame': 'Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)', 'description': 'Definition of clinical improvement (both criteria must be fulfilled):\n\n* Partial resolution of signs and symptoms and\n* microbiological cure or no additional antibiotic therapy for the targeted infection necessary.\n\nDefinition of microbiological cure:\n\n* Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or\n* in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.\n\nTime Frame:\n\nTime point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).'}, {'measure': 'Clinical improvement', 'timeFrame': 'Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)', 'description': 'Definition of clinical improvement (both criteria must be fulfilled):\n\n* Partial resolution of signs and symptoms and\n* microbiological cure or no additional antibiotic therapy for the targeted infection necessary.\n\nDefinition of microbiological cure:\n\n* Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or\n* in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.\n\nTime Frame:\n\nTime point "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.'}, {'measure': 'Clinical improvement', 'timeFrame': 'Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")', 'description': 'Definition of clinical improvement (both criteria must be fulfilled):\n\n* Partial resolution of signs and symptoms and\n* microbiological cure or no additional antibiotic therapy for the targeted infection necessary.\n\nDefinition of microbiological cure:\n\n* Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or\n* in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered.\n\nTime Frame:\n\nDefined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.'}, {'measure': 'Sodium serum levels', 'timeFrame': 'On every day from start of fosfomycin treatment until end of hospital stay (up to 6 months after start of fosfomycin treatment)'}, {'measure': 'Potassium serum levels', 'timeFrame': 'On every day from start of fosfomycin treatment until end of hospital stay (up to 6 months after start of fosfomycin treatment)'}, {'measure': 'Adverse events', 'timeFrame': 'On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)'}, {'measure': 'Non-serious adverse events', 'timeFrame': 'On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)'}, {'measure': 'Serious adverse events', 'timeFrame': 'On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)'}, {'measure': 'Cases of death', 'timeFrame': 'On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)'}, {'measure': 'Adverse drug reactions (ADRs)', 'timeFrame': 'On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)'}, {'measure': 'Serious adverse drug reactions (SADRs)', 'timeFrame': 'On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)'}, {'measure': 'Dropouts due to treatment failure or due to adverse events', 'timeFrame': 'On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Observational Study', 'Non-Interventional Study', 'Registries', 'Prospective', 'Monitored', 'Multicentric', 'International', 'Fosfomycin', 'Infectofos', 'Fomicyt', 'Bacterial Infections', 'Gram-Negative Bacterial Infections', 'Gram-Positive Bacterial Infections', 'Bone Diseases, Infectious', 'Osteomyelitis', 'Central Nervous System Bacterial Infections', 'Meningitis, Bacterial', 'Encephalitis', 'Brain Abscess', 'Urinary Tract Infections', 'Respiratory Tract Infections', 'Pneumonia, Bacterial', 'Skin Diseases, Bacterial', 'Soft Tissue Infections', 'Intraabdominal Infections', 'Sepsis', 'Bacteremia', 'Endocarditis, Bacterial', 'Treatment Outcome', 'Clinical Efficacy', 'Microbiological Efficacy', 'Safety'], 'conditions': ['Bacterial Infections', 'Bone Diseases, Infectious', 'Osteomyelitis', 'Central Nervous System Bacterial Infections', 'Meningitis, Bacterial', 'Encephalitis', 'Brain Abscess', 'Urinary Tract Infections', 'Respiratory Tract Infections', 'Pneumonia, Bacterial', 'Skin Diseases, Bacterial', 'Soft Tissue Infections', 'Intraabdominal Infections', 'Sepsis', 'Bacteremia', 'Endocarditis, Bacterial']}, 'referencesModule': {'references': [{'pmid': '40106180', 'type': 'DERIVED', 'citation': 'Bodmann KF, Hagel S, Oliva A, Kluge S, Mularoni A, Galfo V, Falcone M, Pletz MW, Lindau S, Kading N, Kielstein JT, Zoller M, Tascini C, Kintrup S, Schadler D, Spies C, De Rosa FG, Radnoti S, Bandera A, Luzzati R, Allen S, Sarmati L, Cascio A, Kapravelos N, Subudhi CPK, Dimopoulos G, Vossen MG, Bal AM, Venditti M, Mastroianni CM, Borrmann T, Mayer C. Real-World Use, Effectiveness, and Safety of Intravenous Fosfomycin: The FORTRESS Study. Infect Dis Ther. 2025 Apr;14(4):765-791. doi: 10.1007/s40121-025-01125-2. Epub 2025 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue infection, endocarditis or other infections, each as far as covered by the respective nationally relevant SmPC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients of the participating study sites (clinics specialised and experienced in the management and treatment of patients suffering from (a part of) the included diseases as mentioned in the respective inclusion criterion), who fulfill all inclusion criteria and do not fulfill any of the exclusion criteria, are eligible for participation in the FORTRESS study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged ≥ 18 years\n* Treatment with fosfomycin according to the (national) Summary of Product Characteristics (SmPC) of fosfomycin i.v.\n* Patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue infection, endocarditis or other infection, each as far as covered by the respective nationally relevant SmPC\n* Written informed consent of the participant (or person in charge in case of patients incapable of giving consent)\n\nExclusion Criteria:\n\n* Previous documentation of the patient in the present study\n* Patients participating in an interventional clinical trial\n* Patients with known hypersensitivity to fosfomycin or any of the excipients\n* Terminally ill patients\n* Patients with "do not resuscitate order"\n* Palliative treatment approach\n* Failure of \\> 3 of the following organ systems: respiratory system, nervous system, cardiovascular system, liver, coagulation, kidney\n* Manifest Human Immunodeficiency Virus (HIV) disease (Acquired Immunodeficiency Syndrome, AIDS)\n* Fosfomycin treatment as 4th line treatment or at later stage\n* Patients with involvement of fungi or mycobacteria in the targeted infection'}, 'identificationModule': {'nctId': 'NCT02979951', 'acronym': 'FORTRESS', 'briefTitle': 'Fosfomycin I.v. for Treatment of Severely Infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Infectopharm Arzneimittel GmbH'}, 'officialTitle': 'An International, Multicentre, Non-comparative, Non-interventional, Prospective Clinical Registry to Evaluate the Clinical Outcome and Safety of the Treatment of Severely Infected Patients with Fosfomycin I.v.', 'orgStudyIdInfo': {'id': 'FORTRESS'}}, 'contactsLocationsModule': {'locations': [{'city': 'Hall in Tirol', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Ivo Graziadei, MD', 'role': 'CONTACT'}], 'facility': 'Landeskrankenhaus Hall - Tirol Kliniken', 'geoPoint': {'lat': 47.28333, 'lon': 11.51667}}, {'city': 'Reutte', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Eugen Ladner, MD', 'role': 'CONTACT'}], 'facility': 'A.ö. Bezirkskrankenhaus', 'geoPoint': {'lat': 47.48333, 'lon': 10.71667}}, {'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Matthias Vossen, MD', 'role': 'CONTACT'}], 'facility': 'AKH Wien, Universitätsklinik für Innere Medizin 1', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Wels', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Rainer Gattringer, MD', 'role': 'CONTACT'}], 'facility': 'Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}, {'zip': '10177', 'city': 'Berlin', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'Universitätsmedizin Charité', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12351', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Herwig Gerlach, Prof.', 'role': 'CONTACT'}], 'facility': 'Vivantes Kliniken Neukölln', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '38126', 'city': 'Braunschweig', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jan Kielstein, Dr.', 'role': 'CONTACT'}], 'facility': 'Städtisches Klinikum Braunschweig', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'zip': '40225', 'city': 'Düsseldorf', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'Universitäts Düsseldorf; Klinik für Anästhesiologie', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Frankfurt', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Simone Lindau', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '20251', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan Kluge, Prof.', 'role': 'CONTACT'}], 'facility': 'Universität Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '07740', 'city': 'Jena', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Mathias Pletz, Prof.', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Jena; Zentrum für Infektionsmedizin', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Kiel', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dirk Schädler, Prof.', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '23538', 'city': 'Lübeck', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jan Rupp, Prof.', 'role': 'CONTACT'}], 'facility': 'Universitätsklinik Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '81377', 'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Zoller, Dr.', 'role': 'CONTACT'}], 'facility': 'LMU München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '40149', 'city': 'Münster', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sebastian Kintrup, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Oldenburg in Holstein', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ulf Günther, PD', 'role': 'CONTACT'}], 'facility': 'Klinikum Oldenburg', 'geoPoint': {'lat': 54.29498, 'lon': 10.89043}}, {'zip': '93053', 'city': 'Regensburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Kieninger, Dr. med.', 'role': 'CONTACT'}], 'facility': 'Universitätsklinik Regensburg; Klinik für Anästhesiologie', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '92637', 'city': 'Weiden', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'Kliniken Nordoberpfalz', 'geoPoint': {'lat': 49.67682, 'lon': 12.15613}}, {'city': 'Kifissia', 'state': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Pavlos Myrianthefs, MD', 'role': 'CONTACT'}], 'facility': 'General Oncology Hospital of Kifissia "Agioi Anargiroi"', 'geoPoint': {'lat': 38.07438, 'lon': 23.81106}}, {'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Anastasia Kotanidou, MD', 'role': 'CONTACT', 'email': 'akotanid@med.uoa.gr', 'phone': '+30 6974508199'}], 'facility': 'General Hospital of Athens "Evangelismos"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Georgios Dimopoulos, MD', 'role': 'CONTACT'}], 'facility': 'Sotiria Thoracic Diseases Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Evangelos I. Giamarellos, MD', 'role': 'CONTACT', 'email': 'egiamarel@med.uoa.gr', 'phone': '+30 6932905547'}], 'facility': 'University General Hospital "ATTIKON"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Kifissia', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Ioannis Alamanos, MD', 'role': 'CONTACT'}], 'facility': 'General Hospital of Attica "KAT"', 'geoPoint': {'lat': 38.07438, 'lon': 23.81106}}, {'city': 'Lamia', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Fotios Tsimpoukas, MD', 'role': 'CONTACT', 'email': 'ftsimpoukas@yahoo.gr', 'phone': '+30 6932766976'}], 'facility': 'General Hospital of Lamia', 'geoPoint': {'lat': 38.89947, 'lon': 22.4335}}, {'city': 'Pátrai', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Markos Marangos, MD', 'role': 'CONTACT'}], 'facility': 'RIO Univ. Hospital, Dept of Pathology, Division of Infectious Diseases', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Aikaterini Efthimiou, MD', 'role': 'CONTACT', 'email': 'efthka@gmail.com', 'phone': '+30 6974091279'}], 'facility': '"AHEPA" University General Hospital of Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Areti Karapanagiotou, MD', 'role': 'CONTACT', 'email': 'aretikarapan@gmail.com'}], 'facility': 'General Hospital of Thessaloniki "G. GENIMMATAS"', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Eleni Mouloudi, MD', 'role': 'CONTACT'}], 'facility': 'General Hospital of Thessaloniki "Hippokration"', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Nikolaos Kapravelos, MD', 'role': 'CONTACT'}], 'facility': 'General Hospital of Thessaloniki "G. Papanikolaou"', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '70124', 'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Davide Bavaro, MD', 'role': 'CONTACT'}], 'facility': 'Clinical Malattie Infettive', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Cuneo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Valerio Del Bono, MD', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliera S.Croce e Carle', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Matteo Basetti, MD', 'role': 'CONTACT'}], 'facility': 'Ospedal Policlinico San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Milan', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Ospedale L. Sacco', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandra Mularoni, MD', 'role': 'CONTACT'}], 'facility': 'Istituto Mediterraneo per i Trapianti Ismett IRCCS', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Cascio, MD', 'role': 'CONTACT'}], 'facility': 'Policlinico Paolo Giaccone', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '00161', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mario Venditti, MD', 'role': 'CONTACT'}], 'facility': 'Policlinico Umberto I, Malattie Infettive', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Capone, MD', 'role': 'CONTACT'}], 'facility': 'Lazzaro Spallanzani', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Loredana Sarmati, MD', 'role': 'CONTACT'}], 'facility': 'Polocinico Tor Vergata', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco G. De Rosa, MD', 'role': 'CONTACT'}], 'facility': 'AOU Città della Salute e Scienza-Presidio Molinette', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Udine', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carlo Tascini, MD', 'role': 'CONTACT'}], 'facility': 'Ospedale S.M.della Misericordia', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'city': 'Varese', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo A. Grossi, MD', 'role': 'CONTACT'}], 'facility': 'ASST-Sette Lagh Viale Borre', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'zip': 'BL4 0JR', 'city': 'Bolton', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Bolton Hospital', 'geoPoint': {'lat': 53.58333, 'lon': -2.43333}}, {'zip': 'HU16 5JQ', 'city': 'Cottingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Gavin Barlow, MD', 'role': 'CONTACT'}], 'facility': 'Hull & East Yorkshire Hospitals NHS Trust', 'geoPoint': {'lat': 52.50243, 'lon': -0.7554}}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Benjamin Parcell, MD', 'role': 'CONTACT'}], 'facility': 'Ninewells Hospital', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Abhijit Bal, MD', 'role': 'CONTACT'}], 'facility': 'Queen Elisabeth University Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Michael E Murphy, MD', 'role': 'CONTACT'}], 'facility': 'University of Glasgow/Royal Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'KA2OBB', 'city': 'Kilmarnock', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Sam Allen, MD', 'role': 'CONTACT'}], 'facility': 'University Hospital Crosshouse', 'geoPoint': {'lat': 55.61171, 'lon': -4.49581}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Luke Moore, MD', 'role': 'CONTACT'}], 'facility': 'Chelsea & Westminster Hospial', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Jorge Cepeda, MD', 'role': 'CONTACT'}], 'facility': 'Queen Elisabeth Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Giovanni Satta, MD', 'role': 'CONTACT'}], 'facility': 'Univresity College Londen (UCL) Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Thomas Borrmann, Dr.', 'role': 'CONTACT', 'email': 'Clinical.Trials@infectopharm.com'}, {'name': 'Katja Eifert', 'role': 'CONTACT', 'email': 'Clinical.Trials@infectopharm.com'}], 'overallOfficials': [{'name': 'Klaus-Friedrich Bodmann, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Klinik Nordoberpfalz AG, Klinikum Weiden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Infectopharm Arzneimittel GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'INPADS GmbH', 'class': 'UNKNOWN'}, {'name': 'Dr. Oestreich + Partner GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}