Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-01 @ 3:49 PM
Study NCT ID:
NCT05719259
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2022-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perpetual Observational Study - Ventilator Associated Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}, {'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'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': 20000}, 'targetDuration': '28 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-12', 'studyFirstSubmitDate': '2022-07-06', 'studyFirstSubmitQcDate': '2023-02-07', 'lastUpdatePostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of VAP per 1000 ventilation days', 'timeFrame': '4 years', 'description': 'Incidence of VAP per 1000 ventilation days, measured among the Enrolled population, overal and per site'}, {'measure': 'ICU mortality rate in non-VAP patients', 'timeFrame': '4 years', 'description': 'ICU mortality, measured among the Enrolled population not developping VAP, overal and per site'}, {'measure': 'Time from intubation until VAP diagnosis (days)', 'timeFrame': '4 years', 'description': 'Time from start of invasive mechanical ventilation (IMV) until VAP diagnosis (days), measured among the VAP population, overall and per site'}, {'measure': 'Time under IMV after VAP diagnosis (days)', 'timeFrame': '4 years', 'description': 'Time under IMV after VAP diagnosis (days), measured among the VAP population, measured overall and per site'}, {'measure': 'IMV-free days from VAP diagnosis till day 28 after VAP diagnosis (days)', 'timeFrame': '4 years', 'description': 'IMV-free days from VAP diagnosis till day 28 after VAP diagnosis (days), measured among the VAP population, overall and per site'}, {'measure': 'Length of ICU stay after VAP diagnosis (days)', 'timeFrame': '4 years', 'description': 'Length of ICU stay after VAP diagnosis (days), measured among the VAP population, overall and per site'}, {'measure': 'All-cause mortality at day 28 after VAP diagnosis (%)', 'timeFrame': '4 years', 'description': 'All-cause mortality at day 28 after VAP diagnosis (%), measured among the VAP population, overall and per site'}, {'measure': 'ICU mortality rate', 'timeFrame': '4 years', 'description': 'Mortality rate at ICU discharge, measured among the VAP population, overall and per site'}, {'measure': 'Resolution of signs and symptoms of VAP between days 7 and 10 from VAP diagnosis (%)', 'timeFrame': '4 years', 'description': 'Resolution of signs and symptoms of VAP between days 7 and 10 from VAP diagnosis (%), measured among the VAP population, overall and per site'}], 'primaryOutcomes': [{'measure': 'Number of research sites recruiting patients', 'timeFrame': '4 years', 'description': "POS-VAP' overarching objective is to build a sustainable European clinical research network of ICUs that serves as platform to facilitate observational and randomized VAP research activities.\n\nThis objective will be measured by in three ways:\n\n1\\. Total number of sites in the POS-VAP network that actively recruit patients"}, {'measure': 'Number of patients recruited in the study', 'timeFrame': '4 years', 'description': '2\\. Total number of patients in the POS-VAP network per analysis population (enrolled population, VAP population and microbiologically evaluable VAP population).'}, {'measure': 'Number of studies implemented through the network', 'timeFrame': '4 years', 'description': '3\\. Total number of implemented observational studies and RCTs (stratified by domain: prevention, diagnosis and treatment).'}], 'secondaryOutcomes': [{'measure': 'Proportion of sites recruiting for an study implemented through the network', 'timeFrame': '4 years', 'description': 'Average proportion of sites actively recruiting for at least one embedded study at any time during the study period, overall and stratified by observational and interventional embedded studies.'}, {'measure': 'Proportion of patients enrolled through POS-VAP that are part of a preventive study implemented through the network', 'timeFrame': '4 years', 'description': 'Proportion (%) of POS-VAP enrolled population included in an embedded preventive study, stratified by observational and interventional embedded studies.'}, {'measure': 'Proportion of patients enrolled through POS-VAP that are part of a diagnostic study implemented through the network', 'timeFrame': '4 years', 'description': 'Proportion (%) of POS-VAP enrolled population included in an embedded diagnostic study, stratified by observational and interventional embedded studies.'}, {'measure': 'Proportion of VAP patients enrolled through POS-VAP that are part of a treatment study implemented through the network', 'timeFrame': '4 years', 'description': 'Proportion (%) of POS-VAP VAP population enrolled in at least one embedded treatment study with clinical outcome after VAP as endpoint, stratified by observational and interventional embedded studies.'}]}, 'conditionsModule': {'keywords': ['Ventilator Associated Pneumonia', 'Hospital Acquired Infection', 'Mechanical Ventilation', 'Intensive Care Unit'], 'conditions': ['Ventilator Associated Pneumonia']}, 'referencesModule': {'references': [{'pmid': '35940566', 'type': 'BACKGROUND', 'citation': 'Hassoun-Kheir N, van Werkhoven CH, Dunning J, Jaenisch T, van Beek J, Bielicki J, Butler CC, Francois B, Harbarth S, Hernandez Padilla AC, Horby P, Koopmans M, Lee J, Rodriguez-Bano J, Tacconelli E, Themistocleous Y, van der Velden AW, Bonten M, Goossens H, de Kraker MEA; ECRAID-Base consortium. Perpetual observational studies: new strategies to support efficient implementation of observational studies and randomized trials in infectious diseases. Clin Microbiol Infect. 2022 Dec;28(12):1528-1532. doi: 10.1016/j.cmi.2022.07.024. Epub 2022 Aug 5. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.ecraid.eu/study/pos-vap', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Ventilator-Associated Pneumonia (VAP) is a bacterial respiratory infection that patients in the Intensive Care Unit (ICU) often get when they cannot breathe for themselves and require mechanical ventilation. It is linked to higher chances of death, a longer stay in the hospital, higher costs, and the use of more antibiotics.\n\nOptions to help prevent or treat this disease are in development and will require evaluation in future clinical trials.\n\nThe goal of POS-VAP is to build and continuously train a network of ICUs to be prepared for doing these trials, to facilitate their execution.', 'detailedDescription': 'Ventilator associated pneumonia (VAP) is one of the most frequent healthcare associated infections in the Intensive Care Unit (ICU) and a significant burden among ICU patients under invasive mechanical ventilation (IMV).\n\nSeveral preventive and therapeutic treatment options are being developed in the field of VAP that will require evaluation in future randomized controlled trials (RCTs).\n\nRCTs are the gold standard for evaluating medical interventions but are difficult to perform in a population at risk of, or with, VAP.\n\nThese trials are challenging since it is difficult to recruit a large enough volume of high-quality centers to achieve the required number of recruited patients, especially if the focus is on specific patient groups (e.g., VAP due to a specific pathogen), for which site selection can be even more challenging and time consuming. There is a need for a well-organized and well-trained international network of ICUs focusing on VAP research that enables efficient execution of RCTs on diagnostic, preventive and curative interventions in this population.\n\nThrough a Perpetual Observational Study (POS) we can provide quick access to a network of sites that fulfill pre-specified criteria. Additionally, the structured network of POS sites within ECRAID will maintain continuous activity to carry out observational studies in this specific field, implementing informed consent (where required), increasing quality and efficiency, and facilitating contracting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted to an ICU, who are under IMV and documented or expected to be under IMV for more than 48 hours are eligible to participate in the study', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Age≥18 years\n* At risk of acquiring VAP during ICU stay, defined as:\n* Requiring admission or being admitted to the ICU.\n* Expected or documented to be under IMV for more than 48 hours.\n* Consent, either a written informed consent given by the study patient in full medical, psychological, cognitive, social or legal capacity to give an informed consent, or, if not possible, by a Legally Authorized Representative of the study patient OR any applicable locally accepted form of consent OR consent waiver allowing data collection and sharing of data according to ECRAID's principles\n\nExclusion Criteria:\n\n* Death is deemed to be imminent or inevitable during this hospital admission AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment."}, 'identificationModule': {'nctId': 'NCT05719259', 'acronym': 'POS-VAP', 'briefTitle': 'Perpetual Observational Study - Ventilator Associated Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'European Clinical Research Alliance for Infectious Diseases (ECRAID)'}, 'officialTitle': 'POS-VAP: Perpetual Observational Study - Ventilator Associated Pneumonia', 'orgStudyIdInfo': {'id': 'ECRAID-Base POS-VAP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Enrolled population', 'description': 'All patients meeting eligibility criteria (Adult patients, under a documented or expected time under mechanical ventilation of at least \\>48h) and providing one of:\n\n* Informed consent\n* Hospital level consent\n* Non-objection notice\n* Waiver of consent'}, {'label': 'VAP population', 'description': 'Subset of the enrolled population fulfilling U.S. Food and Drug Administration (FDA) criteria for VAP diagnosis at any time during the follow up'}, {'label': 'Microbiologically evaluable VAP population', 'description': 'Subset of the VAP population with a documented causative agent (bronchoalveolar lavage \\[BAL\\], endotracheal aspirate \\[ETA\\], blood sample, sputum, or pleural fluid) within 48 hours from VAP diagnosis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tirana', 'status': 'RECRUITING', 'country': 'Albania', 'contacts': [{'name': 'Silva LEKA, Dr', 'role': 'CONTACT'}, {'name': 'Silva Leka, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Trauma', 'geoPoint': {'lat': 41.32744, 'lon': 19.81866}}, {'zip': '1200', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Marie-France DUJARDIN', 'role': 'CONTACT', 'email': 'datanurse@saintluc.uclouvain.be'}, {'name': 'Jean-Baptiste MESLAND, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cliniques Universitaires Saint-Luc UCL', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Daisy VERMEIREN', 'role': 'CONTACT', 'email': 'Daisy.Vermeiren@uzgent.be'}, {'name': 'Jan DE WAELE, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '7100', 'city': 'La Louvière', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Anne-Catherine GERARD', 'role': 'CONTACT', 'email': 'Anne-Catherine.GERARD@jolimont.be'}, {'name': 'Isabelle BUELENS', 'role': 'CONTACT', 'email': 'Isabelle.Buelens@jolimont.be'}, {'name': 'Vincent HUBERLANT, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital de Jolimont', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}, {'zip': '4000', 'city': 'Liège', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Axelle BERTRAND', 'role': 'CONTACT', 'email': 'axelle.bertrand@chuliege.be'}, {'name': 'LAMBERMONT Bernard, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '1340', 'city': 'Ottignies-Louvain-la-Neuve', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Belgium', 'facility': 'Clinique Saint Pierre Ottignies', 'geoPoint': {'lat': 50.66714, 'lon': 4.55023}}, {'city': 'Rijeka', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Ivana ARAPOVIC', 'role': 'CONTACT', 'email': 'Ivana.Arapovic@kbc-rijeka.hr'}, {'name': 'Nataša SKOCIBUSIC', 'role': 'CONTACT', 'email': 'natasa.skocibusic@gmail.com'}, {'name': 'Vera VLAHOVIC-PALCEVSKI, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinical Hospital Center Rijeka', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'city': 'Slavonski Brod', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Jasminka KOPIC', 'role': 'CONTACT', 'email': 'Jasminka.Kopic@bolnicasb.hr'}, {'name': 'Jasminka KOPIC, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'General Hospital "Dr. Josip Benčević" Slavonski Brod', 'geoPoint': {'lat': 45.16158, 'lon': 18.0163}}, {'city': 'Zagreb', 'status': 'NOT_YET_RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Arjana TAMBIC', 'role': 'CONTACT', 'email': 'arjana.tambic@bfm.hr'}, {'role': 'CONTACT', 'email': 'ibutic@bfm.hr'}, {'name': 'Branimir GJURASIN, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital for Infectious Diseases', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Eva ALJAMAL', 'role': 'CONTACT', 'email': 'Eva.Aljamal@fnmotol.cZ'}, {'name': 'Sarka SPECIANOVA', 'role': 'CONTACT', 'email': 'Sarka.Specianova@fnmotol.cz'}, {'name': 'Jaromir VAJTER, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Motol', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Vinohrady', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Tereza CIBULKOVA', 'role': 'CONTACT', 'email': 'tereza.cibulkova@fnkv.cz'}, {'name': 'Nikola BANDIKOVA', 'role': 'CONTACT', 'email': 'nikola.bandikova@fnkv.cz'}, {'name': 'Frantisek DUSKA, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Kralovske Vinohrady', 'geoPoint': {'lat': 49.20655, 'lon': 16.66317}}, {'zip': '71100', 'city': 'Chalon-sur-Saône', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claudine DESBROSSES', 'role': 'CONTACT', 'email': 'Claudine.Desbrosses@ch-chalon71.fr'}, 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'CONTACT', 'email': 'Amelie.CERF@chu-lille.fr'}, {'name': 'Saad NSEIR, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Régional Universitaire de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87000', 'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Théo MERIGUET', 'role': 'CONTACT', 'email': 'Theo.MERIGUET@chu-limoges.fr'}, {'name': 'Thomas DAIX, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire Dupuytren of Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '37000', 'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Delphine CHARTIER', 'role': 'CONTACT', 'email': 'D.CHARTIER@chu-tours.fr'}, {'name': 'Denis GAROT, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '04103', 'city': 'Leipzig', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Bastian PASIEKA, dR', 'role': 'CONTACT', 'email': 'bastian.pasieka@uni-leipzig.de'}, {'name': 'Sirak PETROS, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '68100', 'city': 'Alexandroupoli', 'status': 'NOT_YET_RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Vasileios PAPAIOANNOU, Pr', 'role': 'CONTACT', 'email': 'papabil69@gmail.com'}, {'name': 'Vasileios PAPAIOANNOU, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Alexandroupolis', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'zip': '10676', 'city': 'Athens', 'status': 'NOT_YET_RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Eirini DAIKOU', 'role': 'CONTACT', 'email': 'eirini.daikou@gmail.com'}, {'name': 'Maria THEODORAKOPOULOU', 'role': 'CONTACT', 'email': 'mariatheodor10@gmail.com'}, {'name': 'Anastasia KOTANIDOU, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Evangelismos General Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11527', 'city': 'Athens', 'status': 'NOT_YET_RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Kostis PONTIKIS, Dr', 'role': 'CONTACT', 'email': 'kostis_pontikis@yahoo.gr'}, {'name': 'Antonia KOUTSOUKOU, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sotiria Thoracic Diseases Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '41334', 'city': 'Larissa', 'status': 'NOT_YET_RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Demosthenes', 'role': 'CONTACT', 'email': 'dimomakris@uth.gr'}, {'role': 'CONTACT', 'email': 'appollon7@hotmail.com'}, {'name': 'Demosthenes MAKRIS, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'General University Hospital of Larissa', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'city': 'Roma', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Valentina DI GRAVIO', 'role': 'CONTACT', 'email': 'valentinadigravio@gmail.com'}, {'name': 'Gennaro DE PASCALE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Ospedale Policlinico Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '7416', 'city': 'Deventer', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Arriette KRUISDIJK-GERRITSEN', 'role': 'CONTACT', 'email': 'A.Gerritsen@dz.nl'}, {'name': 'H VAN DEN OEVER, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Deventer Ziekenhuis', 'geoPoint': {'lat': 52.255, 'lon': 6.16389}}, {'zip': '3584', 'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Brittney VAN DER WOUDE', 'role': 'CONTACT', 'email': 'B.A.vanderWoude@umcutrecht.nl'}, {'name': 'Olaf CREMER, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lennie DERDE, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Bucharest', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Filomon RALUCA', 'role': 'CONTACT', 'email': 'filimon_raluca@yahoo.ro'}, {'name': 'Dan CORNECI, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Central Military Emergency University Hospital Dr. Carol Davila', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Oanamaria TUDORACHE', 'role': 'CONTACT', 'email': 'oanamaria.tudorache@yahoo.com'}, {'name': 'Silvius NEGOITA, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Elias University Emergency Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '11000', 'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'contacts': [{'name': 'Biljana CAREVIC', 'role': 'CONTACT', 'email': 'biljana.carevic@gmail.com'}, {'name': 'Ivana RADOVANOVIC', 'role': 'CONTACT', 'email': 'icaradovanovic@gmail.com'}, {'name': 'Alexandra BARAC, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Biljana CAREVIC, Pr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Clinical Center of Serbia', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '14004', 'city': 'Córdoba', 'state': 'Cordoba', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rafael LEON LOPEZ, Dr', 'role': 'CONTACT', 'email': 'RAFAEL.LEON.LOP@hotmail.com'}, {'name': 'Rafael LEON LOPEZ, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Reina Sofia', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '33011', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Lorena FORCELLEDO, Dr', 'role': 'CONTACT', 'email': 'lforcelledoespina@yahoo.es'}, {'name': 'Dolores ESCUDERO, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lorena FORCELLEDO, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '46100', 'city': 'Burjassot', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose EXPOSITO OLLERO', 'role': 'CONTACT', 'email': 'jexposito@imedhospitales.com'}, {'name': 'Mercedes MURCIA ANAYA, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IMED Valencia', 'geoPoint': {'lat': 39.50984, 'lon': -0.41327}}, {'zip': '08035', 'city': 'Barcelona', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Spain', 'facility': "Vall d'Hebrón University Hospital", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Cambridge', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Andrew CONWAY MORRIS, Dr', 'role': 'CONTACT', 'email': 'ac926@cam.ac.uk'}, {'name': 'Andrew CONWAY MORRIS, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'John V Farman Intensive Care Unit', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'EH164SA', 'city': 'Edinburgh', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Thomas CRAVEN, Dr', 'role': 'CONTACT', 'email': 'Thomas.Craven@ed.ac.uk'}, {'name': 'Thomas CRAVEN, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Infirmary of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'NE14LP', 'city': 'Newcastle', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Thomas HELLYER, Dr', 'role': 'CONTACT', 'email': 'Thomas.Hellyer@newcastle.ac.uk'}, {'name': 'Thomas HELLYER, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Victoria Infirmary', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}], 'centralContacts': [{'name': 'Bruno FRANCOIS, MD', 'role': 'CONTACT', 'email': 'bruno.francois@chu-limoges.fr', 'phone': '+33 05 55 05 69 83'}, {'name': 'Ana HERNANDEZ, MD, PhD', 'role': 'CONTACT', 'email': 'ana.hernandez@chu-limoges.fr', 'phone': '+33 07 65 15 04 00'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data from this study will be used to inform future observational studies and RCTs about expected frequencies of exposures and clinical outcomes and expected recruitment rates for specific patient populations. Furthermore, the data will be used to support simulations to gain insight in the optimal design and required sample size of future RCTs as required for future embedded studies, which will be described in the appendices.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Clinical Research Alliance for Infectious Diseases (ECRAID)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire Dupuytren de Limoges (CHUL)', 'class': 'UNKNOWN'}, {'name': 'Université de Genève (UNIGE)', 'class': 'UNKNOWN'}, {'name': 'University Medical Center Utrecht (UMCU)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}