Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-29 @ 5:25 AM
Study NCT ID:
NCT06134492
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2023-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acyclovir in Ventilated Patients With Pneumonia and HSV-1 in BAL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}, {'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}, {'id': 'D006561', 'term': 'Herpes Simplex'}, {'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000212', 'term': 'Acyclovir'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 616}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2023-11-01', 'studyFirstSubmitQcDate': '2023-11-10', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality (survival status)', 'timeFrame': 'day 30', 'description': 'survival status'}], 'secondaryOutcomes': [{'measure': 'Ventilation-free days', 'timeFrame': 'day 30', 'description': 'days without mechanically ventilation via endotracheal tube, incl. tracheostoma'}, {'measure': 'Vasopressor-free days', 'timeFrame': 'day 30', 'description': 'days without continuous vasopressor administration \\> 1h/day'}, {'measure': 'Delta SOFA score (Sepsis-related Organ Failure Assessment Score)', 'timeFrame': 'Baseline - Day 10 or EOT if this event occurs earlier', 'description': 'Each of six organ systems receive a score ranging from 0 (normal) to 4 (most abnormal), with a minimum SOFA score of 0 and a maximum SOFA score of 24'}, {'measure': 'Delta SOFA sub-score kidney (Sepsis-related Organ Failure Assessment Score)', 'timeFrame': 'Baseline - Day 10 or EOT if this event occurs earlier', 'description': 'Sub-score for kidney function, the score ranges from 0 (normal) to 4 (most abnormal)'}, {'measure': 'Delta GFR value', 'timeFrame': 'Baseline - Day 10 or EOT if this event occurs earlier', 'description': 'GFR value'}, {'measure': 'Length of stay in ICU', 'timeFrame': 'day 30', 'description': 'days LOS in ICU'}, {'measure': 'Length of stay in Hospital', 'timeFrame': 'day 30', 'description': 'days LOS in hospital'}, {'measure': 'Cost of intervention', 'timeFrame': 'up to day 90', 'description': 'ICU and hospitalization days + acyclovir'}, {'measure': 'Days without delirium/coma', 'timeFrame': 'Until day 10 or until EOT if this event occurs earlier', 'description': 'based on CAM-ICU / RASS'}, {'measure': 'Microbiological cure (EOT)', 'timeFrame': 'At day 10 or day of EOT if this event occurs earlier', 'description': 'Percent of participants with HSV eradication (PCR testing negative) in blood and respiratory tract'}, {'measure': 'mortality (survival status)', 'timeFrame': '90 days', 'description': 'survival status'}, {'measure': 'mortality (survival status)', 'timeFrame': '180 days', 'description': 'survival status'}, {'measure': 'Quality of life (EQ-5D-5L)', 'timeFrame': 'Measurement at day 10 or EOT if this event occurs earlier, day 30, day 90, and day 180', 'description': 'EuroQuality of Life Five Dimensions (EQ-5D-5L), the descriptive system comprises five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), with five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems.'}, {'measure': 'Incidence SAEs', 'timeFrame': 'From time of randomization until day 10 or EOT if this event occurs earlier', 'description': 'Incidence of serious adverse events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pneumonia', 'Herpes Simplex', 'Mechanical Ventilation', 'Aciclovir'], 'conditions': ['Pneumonia, Viral', 'Ventilator Associated Pneumonia', 'Community-acquired Pneumonia', 'Herpes Simplex', 'Hospital-acquired Pneumonia']}, 'referencesModule': {'references': [{'pmid': '38670599', 'type': 'DERIVED', 'citation': 'Hagel S, Brillinger N, Decker S, Deja M, Ertmer C, Fiedler S, Franken P, Heim M, Weigand MA, Zarbock A, Pletz MW; SepNet Critical Care Trials Group. Effect of acyclovir therapy on the outcome of mechanically ventilated patients with lower respiratory tract infection and detection of herpes simplex virus in bronchoalveolar lavage: protocol for a multicentre, randomised controlled trial (HerpMV). BMJ Open. 2024 Apr 25;14(4):e082512. doi: 10.1136/bmjopen-2023-082512.'}], 'seeAlsoLinks': [{'url': 'https://bmjopen.bmj.com/content/14/4/e082512', 'label': 'Study protocol'}]}, 'descriptionModule': {'briefSummary': "Almost 90 out of 100 people carry herpes simplex viruses (HSV). Once a person has been infected with the herpes viruses, he or she can't get rid of them for the rest of her/his life. For the most part, the viruses are in a dormant state. Only when the immune system is weakened, for example in the case of a serious illness or stress, are the viruses reactivated. They then mainly cause cold sores, which are harmless for healthy people and usually heal without therapy. However, especially in people with a weakened immune system, HSV can also cause serious infections, such as meningitis. In almost every second mechanically ventilated patient in intensive care who has pneumonia, HSV can be detected in the respiratory tract. This is caused by reactivation of the viruses as a result of the severe underlying disease and stress during intensive care therapy. Whether treatment of the herpes viruses (e.g. with acyclovir) is necessary in this situation and helps the patients to cure has not been clarified, especially as acyclovir can also cause side effects such as a deterioration in kidney function. Currently, the physicians decide to treat the herpes viruses in about half of the patients. Several studies have shown that patients for whom the physician decided to treat the viruses survived more often. However, all of these studies looked at the course of the disease only retrospectively and thus are subject to many biases (including physician selection of who receives treatment, missing data). A definitive conclusion as to whether herpesvirus therapy can be recommended cannot be drawn without doubt from these studies. Therefore, the investigators would like to investigate in a randomized controlled trial, i.e. patients are randomly assigned to the experimental (therapy of herpesviruses) or control group (no therapy of herpesviruses), the effect of therapy with acyclovir on survival in ventilated intensive care patients with lower respiratory tract infection (pneumonia) in whom a large amount of HSV was found in the respiratory tract. The goal of the study is to provide clarity on whether therapy will help patients recover.", 'detailedDescription': 'Herpes-simplex virus (HSV) can be detected in the bronchoalveolar lavage (BAL) in up to 60% of mechanically ventilated (MV) ICU patients with a lower respiratory tract infection (LRTI), depending on the study population and the severity of disease. However, it remains unclear whether the detection represents a harmless viral shedding as a consequence of reactivation, reflecting the severity of the underlying disease and immunoparalysis, or a true clinical infection requiring antiviral therapy. To date, only retrospective studies have investigated the benefit of an antiviral therapy in HSV-positive ICU patients on mechanical ventilation (MV) with LRTI. In a retrospective study and additional meta-analysis on this topic a antiviral treatment was associated with an improved patient outcome, i.e.; lower all-cause hospital mortality (RR 0.74, 95% CI 0.64-0.85) and lower 30-day all-cause mortality (RR 0.75, 95% CI 0.59-0.94; 3 studies). Aim of this study is to determine prospectively in a multicenter, randomized controlled trial whether acyclovir therapy improves outcome in ventilated ICU patients with a LRTI and HSV detection in BAL. Overall, 616 ICU patients with MV and LRTI and HSV1-PCR-detection in BAL (\\>= 10E3 copies/ml) will be either randomized to receive acyclovir (10mg/kg body weight tid) for 10 days (or discharge from ICU if this is earlier) or no antiviral therapy (control group). Primary efficacy endpoint will be overall survival within 30 days comparing the acyclovir therapy and the control group. Secondary endpoints include ventilation-free days up to day 30, vasopressor-free days until day 30 and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 18 years\n2. need for invasive or non-invasive respiratory support\n3. PCR HSV-1 detection in BAL (≥ 10\\^3 copies/ml)\n4. Pneumonia (community or healthcare acquired, incl. ventilator-associated pneumonia)\n5. declaration of consent by the patient or legal representative\n\nExclusion Criteria:\n\n1. History of hypersensitivity to acyclovir or valacyclovir or other components of the investigational product.\n2. Pregnancy/Lactation\n3. Simultaneous participation in another interventional clinical trial\n4. Decision to withhold life-sustaining therapies\n5. Use of a virostatic agent (i.v. or p. os) with activity against herpes simplex (acyclovir, valacyclovir, famciclovir/penciclovir, brivudine, cidofovir, foscarnet) for therapeutic or prophylactic reasons at the time of randomization.\n6. Solid organ transplantation, stem cell transplantation\n7. Neutropenia (absolute neutrophil count \\<1500/μl (\\<1.5 × 109 /l)\n8. Previous study participation in HerpMV'}, 'identificationModule': {'nctId': 'NCT06134492', 'acronym': 'HerpMV', 'briefTitle': 'Acyclovir in Ventilated Patients With Pneumonia and HSV-1 in BAL', 'organization': {'class': 'OTHER', 'fullName': 'Jena University Hospital'}, 'officialTitle': 'Effect of Acyclovir Therapy on the Outcome of Ventilated Patients With Lower Respiratory Tract Infection and Detection of Herpes Simplex Virus in Bronchoalveolar Lavage', 'orgStudyIdInfo': {'id': 'ZKSJ0153'}, 'secondaryIdInfos': [{'id': 'BMBF 01KG2301', 'type': 'OTHER_GRANT', 'domain': 'Federal Ministry of Education and Research'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Aciclovir therapy', 'interventionNames': ['Drug: Acyclovir']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison group', 'description': 'No study-specific treatment measures'}], 'interventions': [{'name': 'Acyclovir', 'type': 'DRUG', 'otherNames': ['Aciclovir'], 'description': 'Dosage: 10mg/kg (current) body weight every 8 hours, dose adjustment to renal function according to technical information.\n\nMode of administration: intravenous (i.v.)', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79106', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Paul Biever, Dr.', 'role': 'CONTACT', 'email': 'paul.biever@uniklinik-freiburg.de', 'phone': '076127034931'}, {'name': 'Paul Biever, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Markus Weigand, Prof. Dr.', 'role': 'CONTACT', 'email': 'anae.sekretariat@med.uni-heidelberg.de', 'phone': '06221 56-36351'}, {'name': 'Markus Weigand, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tobias Gutting, Dr.', 'role': 'CONTACT', 'email': 'tobias.gutting@med.uni-heidelberg.de', 'phone': '062215637985'}, {'name': 'Tobias Gutting, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter Rosenberger, Prof. Dr.', 'role': 'CONTACT', 'email': 'peter.rosenberger@med.uni-tuebingen.de', 'phone': '070712986622'}, {'name': 'Peter Rosenberger, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '86156', 'city': 'Augsburg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Phillip Simon, Prof. Dr.', 'role': 'CONTACT', 'email': 'philipp.simon3@uk-augsburg.de', 'phone': '08214002378'}, {'name': 'Phillip Simon, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '81377', 'city': 'München', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Zoller, Dr.', 'role': 'CONTACT', 'email': 'michael.zoller@med.uni-muenchen.de', 'phone': '015254849023'}, {'name': 'Michael Zoller, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum der Ludwig-Maximilian-Universität München', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '81675', 'city': 'München', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Markus Heim, Dr.', 'role': 'CONTACT', 'email': 'm.heim@tum.de', 'phone': '08941405990'}, {'name': 'Markus Heim, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum rechts der Isar', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '81675', 'city': 'München', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tobias Lahmer, Dr.', 'role': 'CONTACT', 'email': 'tobias.lahmer@mri.tum.de', 'phone': '08941409345'}, {'name': 'Tobias Lahmer, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum rechts der Isar', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '90419', 'city': 'Nuremberg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Arnim Geise, Dr.', 'role': 'CONTACT', 'email': 'arnim.geise@klinikum-nuernberg.de', 'phone': '09113983479'}, {'name': 'Arnim Geise, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum Nürnberg, Campus Nord', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '90471', 'city': 'Nuremberg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Silke Fortenbacher, Dr.', 'role': 'CONTACT', 'email': 'silke.fortenbacher@klinikum-nuernberg.de', 'phone': '0911398118734'}, {'name': 'Silke Fortenbacher, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum Nürnberg, Campus Süd', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '93053', 'city': 'Regensburg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alexander Dejaco, Dr.', 'role': 'CONTACT', 'email': 'alexander.dejaco@klinik.uni-regensburg.de', 'phone': '09419447801'}, {'name': 'Alexander Dejaco, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '83022', 'city': 'Rosenheim', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Balázs Poros, Dr.', 'role': 'CONTACT', 'email': 'balzs.poros@ro-med.de', 'phone': '080313656841'}, {'name': 'Balázs Poros, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'RoMed Klinikum Rosenheim', 'geoPoint': {'lat': 47.85637, 'lon': 12.12247}}, {'zip': '44625', 'city': 'Herne', 'state': 'Nordreihn-Westfalen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ulrich Frey, Prof. Dr.', 'role': 'CONTACT', 'email': 'ulrich.frey@elisabethgruppe.de', 'phone': '023234991575'}, {'name': 'Ulrich Frey, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'zip': '33617', 'city': 'Bielefeld', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Friedhelm Bach, Dr.', 'role': 'CONTACT', 'email': 'friedhelm.bach@evkb.de', 'phone': '052177279107'}, {'name': 'Friedhelm Bach, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Evangelisches Klinikum Bethel', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'zip': '53127', 'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Putensen, Prof. Dr.', 'role': 'CONTACT', 'email': 'putensen@uni-bonn.de', 'phone': '022828714119'}, {'name': 'Christian Putensen, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Fabian Dusse, Dr.', 'role': 'CONTACT', 'email': 'fabian.dusse@uk-koeln.de', 'phone': '022147842113'}, {'name': 'Fabian Dusse, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Köln AöR', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Jung, Prof. Dr.', 'role': 'CONTACT', 'email': 'christian.jung@med.uni-duesseldorf.de', 'phone': '02118118801'}, {'name': 'Christian Jung, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '45147', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thorsten Brenner, Prof. Dr.', 'role': 'CONTACT', 'email': 'anaesthesiologie@uk-essen.de', 'phone': '0201 723 1401'}, {'name': 'Thorsten Brenner, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '48149', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Ertmer, Prof. Dr.', 'role': 'CONTACT', 'email': 'ertmer@anit.uni-muenster.de', 'phone': '02518348735'}, {'name': 'Christian Ertmer, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andreas Güldner, Dr. med.', 'role': 'CONTACT', 'email': 'andreas.gueldner@ukdd.de', 'phone': '035145818493'}, {'name': 'Andreas Güldner, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sirak Petros, Prof. Dr.', 'role': 'CONTACT', 'email': 'MB-Internistische-Intensivmedizin@medizin.uni-leipzig.de', 'phone': '03419712700'}, {'name': 'Sirak Petros, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Gunther Hempel, Dr.', 'role': 'CONTACT', 'email': 'studien-kai@medizin.uni-leipzig.de', 'phone': '03419717136'}, {'name': 'Gunther Hempel, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '06120', 'city': 'Halle', 'state': 'Saxony-Anhalt', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alexander Vogt, Dr.', 'role': 'CONTACT', 'email': 'alexander.vogt@uk-halle.de', 'phone': '03455573134'}, {'name': 'Alexander Vogt, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Halle', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Matthias Lindner, Dr.', 'role': 'CONTACT', 'email': 'Matthias.Lindner@uksh.de', 'phone': '043150068103'}, {'name': 'Matthias Lindner, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Schleswig-Holstein Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Maria Deja, Prof. Dr.', 'role': 'CONTACT', 'email': 'maria.deja@uksh.de', 'phone': '045150040710'}, {'name': 'Maria Deja, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Schleswig-Holstein Campus Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '07747', 'city': 'Jena', 'state': 'Thuringia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Frank Bloos, PD Dr.', 'role': 'CONTACT', 'email': 'frank.bloos@med.uni-jena.de', 'phone': '036419323283'}], 'facility': 'Universitätsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '33611', 'city': 'Bielefeld', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Friedhelm Bach, Dr.', 'role': 'CONTACT', 'email': 'friedhelm.bach@evkb.de', 'phone': '049 521 77279107'}, {'name': 'Friedhelm Bach, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Evangelisches Klinikum Bethel', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan Kluge, Prof. Dr.', 'role': 'CONTACT', 'email': 's.kluge@uke.de', 'phone': '040741057010'}, {'name': 'Stefan Kluge, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Hamburg Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After publication', 'ipdSharing': 'YES', 'description': 'Results will be published in a journal indexed in MEDLINE and CTIS; there are no publication restrictions. After publication, deidentified, individual participant data that underlie this trial, along with a data dictionary describing variables in the dataset, will be made available to researchers whose proposed purpose of use is approved by the Trial Management Team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jena University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stefan Hagel', 'investigatorAffiliation': 'Jena University Hospital'}}}}