Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-29 @ 12:25 AM
Study NCT ID:
NCT06156566
Status:
RECRUITING
Last Update Posted:
2025-03-28
First Post:
2023-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
European Trial Into Mpox Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045908', 'term': 'Mpox, Monkeypox'}], 'ancestors': [{'id': 'D011213', 'term': 'Poxviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018419', 'term': 'Primate Diseases'}, {'id': 'D000820', 'term': 'Animal Diseases'}, {'id': 'D012376', 'term': 'Rodent Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C505045', 'term': 'tecovirimat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The trial is controlled with matching placebo. Unblinding after database lock.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2023-11-27', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to complete mpox lesion resolution', 'timeFrame': '28 days', 'description': 'Time in days until day 28 after randomization, until the first day on which all lesions are completely healed with a new fresh layer of skin.'}], 'secondaryOutcomes': [{'measure': 'Time to active lesion resolution', 'timeFrame': '28 days', 'description': 'The first day on which all skin lesions are scabbed or desquamated (and mucosal lesions healed), counted from start of therapy, with follow-up up to 28 days after randomisation'}, {'measure': 'Status of the lesions on day 7, 14 and 28', 'timeFrame': 'Day 7, day 14 and day 28', 'description': 'Status of the lesions on day 7, 14, 21 and 28 according to an ordinal scale. The ordinal scale is a) all lesions completely resolved (all scabs dropped off and intact skin remains underneath, and all mucosal lesions healed), b) active lesions resolved (all skin lesions scabbed or desquamated, but not fully resolved), c) active lesions persist but no new lesions in last 24 hours, d) new lesion(s) in last 24 hours.'}, {'measure': 'Time to resolution of symptoms', 'timeFrame': '90 days', 'description': 'Time to resolution of symptoms. Symptoms are counted from start of therapy and assessed by self-assessment. These include fatigue, malaise, nausea, vomiting, abdominal pain, anorexia, cough, dysphagia, odynophagia, fever, headache, oral pain, pain with urination, rectal/anal pain. Signs will be evaluated at study visits only, including lymphadenopathy and proctitis, and are not included in the evaluation of symptoms.'}, {'measure': 'Occurrence of a negative monkeypox PCR of skin or mucosal swab', 'timeFrame': 'Days 7, 14 and 28', 'description': 'Negative monkeypox PCR (Polymerase Chain Reaction) of skin or mucosal swab, assessed for the two most active skin lesions or for the mucosal lesion.'}, {'measure': 'Persistence of scars and skin discoloration', 'timeFrame': 'Assessed on day 90', 'description': 'Assessment of scars and/or skin discoloration of mpox lesions.'}, {'measure': 'Change from baseline in quality of life', 'timeFrame': 'Assessed on day 14 and day 90.', 'description': 'Change from baseline of quality of life, assessed by the Dermatology Life Quality Index (DLQI).\n\nMinimum value = 0, maximum value = 30, a higher score indicates a worse outcome. (Ten questions with each a minimum of 0 and a maximum of 3.)'}, {'measure': 'All-cause mortality', 'timeFrame': 'Assessed on day 28 and on day 90', 'description': 'All-cause mortality'}, {'measure': 'Time to complication or all-cause admission to hospital or all-cause death', 'timeFrame': 'Assessed within 28 days and within 90 days.', 'description': 'Time to complication or all-cause admission to hospital or all-cause death, within 28 days and within 90 days, applicable to outpatients only, and counted from start of therapy. A complication includes genitourinary complications (e.g. urinary retention, paraphimosis), lower respiratory tract complication (e.g. pneumonia and need for oxygen), ocular impairment (e.g. keratitis), neurologic impairment (e.g. encephalitis) or mental health disturbance (e.g. confusion), cardiac impairment (e.g. cardiomyopathy or myocarditis), severe dehydration needing admission, secondary bacterial skin infection or severe pain needing hospital admission.'}, {'measure': 'Frequency of AEs, SAEs and SUSARs', 'timeFrame': 'Assessed within 28 days and within 90 days.', 'description': 'Frequency of Adverse Events (AEs), Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reaction (SUSARs) for the specific therapeutic, within the first 28 days, but also assessed during the total follow-up (up to day 90).'}, {'measure': 'Resolution of pain', 'timeFrame': 'Assessed on days 7, 14 and 90.', 'description': 'Resolution of pain, by measuring:\n\n1. time to resolution of pain assessed by the Numeric Rating Scale (NRS) for pain,\n2. time to cessation of the use of analgesic medication, defined as time to consistently reporting no use of analgesia for mpox-related lesions, up to 90 days after randomisation.\n3. anal pain on days 7, 14, and 90 assessed by the Health Related Symptom Index.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tecovirimat', 'mpox', 'TPOXX'], 'conditions': ['Monkeypox']}, 'referencesModule': {'references': [{'pmid': '9300470', 'type': 'BACKGROUND', 'citation': 'Wedekind C. The infectivity, growth, and virulence of the cestode Schistocephalus solidus in its first intermediate host, the copepod Macrocyclops albidus. Parasitology. 1997 Sep;115 ( Pt 3):317-24. doi: 10.1017/s0031182097001406.'}, {'pmid': '9364300', 'type': 'BACKGROUND', 'citation': 'Jang TJ, Lee JI, Kim JR, Kim DH, Bae SH. Decreased gastric proliferation of foveolar epithelial cells after the eradication of Helicobacter pylori. J Korean Med Sci. 1997 Oct;12(5):421-6. doi: 10.3346/jkms.1997.12.5.421.'}, {'type': 'BACKGROUND', 'citation': 'Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J R Statist Soc B 1995;57(1):289-300.'}, {'pmid': '8870502', 'type': 'BACKGROUND', 'citation': 'Horton JA, Cruess DF, Romans MC. Compliance with mammography screening guidelines: 1995 Mammography Attitudes and Usage Study Report. Womens Health Issues. 1996 Sep-Oct;6(5):239-45. doi: 10.1016/1049-3867(96)00037-0. No abstract available.'}, {'pmid': '6093301', 'type': 'BACKGROUND', 'citation': 'Zherbin EA, Chukhlovin AB. [Loss of specific membrane receptors during the interphase death of thymus cells]. Tsitologiia. 1984 Aug;26(8):973-7. Russian.'}, {'pmid': '7179270', 'type': 'BACKGROUND', 'citation': 'Asaki S, Hatori S, Iwai S, Nishimura T, Sato A, Goto Y. Diagnosis of submucosal tumors by injecting a water soluble contrast medium: basic research and imaging of tumors. Tohoku J Exp Med. 1982 Oct;138(2):121-30. doi: 10.1620/tjem.138.121.'}, {'type': 'BACKGROUND', 'citation': 'EMA: An overview of Tecovirimat SIGA and why it is authorised in the EU. 31-May-2022: https://www.ema.europa.eu/en/documents/overview/tecovirimat-siga-epar-medicine-overview_en.pdf'}, {'type': 'BACKGROUND', 'citation': 'EMA: Summary of product characteristics: www.ema.europa.eu/en/documents/product-information/tecovirimat-siga-epar-product-information_en.pdf, accessed 6-9-2022'}, {'pmid': '6086581', 'type': 'BACKGROUND', 'citation': 'Mock M, Miyada CG, Collier RJ. Genetic analysis of the functional relationship between colicin E3 and its immunity protein. J Bacteriol. 1984 Aug;159(2):658-62. doi: 10.1128/jb.159.2.658-662.1984.'}, {'pmid': '3185746', 'type': 'BACKGROUND', 'citation': 'Grohmann M, Henseling M. Lack of differences between the neuronal and extraneuronal handling of 3H-7- and 3H-ring-2,5,6-(-)noradrenaline. Naunyn Schmiedebergs Arch Pharmacol. 1988 Aug;338(2):180-4. doi: 10.1007/BF00174867.'}, {'pmid': '30120738', 'type': 'BACKGROUND', 'citation': 'Hoy SM. Tecovirimat: First Global Approval. Drugs. 2018 Sep;78(13):1377-1382. doi: 10.1007/s40265-018-0967-6.'}, {'pmid': '22343650', 'type': 'BACKGROUND', 'citation': 'Howard G, Waller JL, Voeks JH, Howard VJ, Jauch EC, Lees KR, Nichols FT, Rahlfs VW, Hess DC. A simple, assumption-free, and clinically interpretable approach for analysis of modified Rankin outcomes. Stroke. 2012 Mar;43(3):664-9. doi: 10.1161/STROKEAHA.111.632935. Epub 2012 Feb 16.'}, {'pmid': '3029395', 'type': 'BACKGROUND', 'citation': 'Jezek Z, Nakano JH, Arita I, Mutombo M, Szczeniowski M, Dunn C. Serological survey for human monkeypox infections in a selected population in Zaire. J Trop Med Hyg. 1987 Feb;90(1):31-8.'}, {'type': 'BACKGROUND', 'citation': 'Joint ECDC-WHO Regional Office for Europe Monkeypox Surveillance Bulletin, published 31-8-2022: monkeypoxreport.ecdc.europa.eu, accessed 6-9-2022'}, {'pmid': '2681496', 'type': 'BACKGROUND', 'citation': 'Tritrakarn A. Pulmonary sequestration: ultrasonographic visualization of feeding artery. J Med Assoc Thai. 1989 Aug;72(8):465-8.'}, {'pmid': '3185582', 'type': 'BACKGROUND', 'citation': 'Mitchell DL. The induction and repair of lesions produced by the photolysis of (6-4) photoproducts in normal and UV-hypersensitive human cells. Mutat Res. 1988 Nov;194(3):227-37. doi: 10.1016/0167-8817(88)90024-7.'}, {'pmid': '29321111', 'type': 'BACKGROUND', 'citation': 'Karcioglu O, Topacoglu H, Dikme O, Dikme O. A systematic review of the pain scales in adults: Which to use? Am J Emerg Med. 2018 Apr;36(4):707-714. doi: 10.1016/j.ajem.2018.01.008. Epub 2018 Jan 6.'}, {'type': 'BACKGROUND', 'citation': 'Label FDA: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214518s000lbl.pdf, accessed 6-9-2022'}, {'type': 'BACKGROUND', 'citation': 'McCullagh P. Regression models for ordinal data (with discussion). J R Statist Soc B. 1980;42:109-42.'}, {'pmid': '9331915', 'type': 'BACKGROUND', 'citation': 'Germer A, Jahnke C, Mack A, Enzmann V, Reichenbach A. Modification of glutamine synthetase expression by mammalian Muller (glial) cells in retinal organ cultures. Neuroreport. 1997 Sep 29;8(14):3067-72. doi: 10.1097/00001756-199709290-00012.'}, {'pmid': '9284919', 'type': 'BACKGROUND', 'citation': "Wienberg J, Stanyon R, Nash WG, O'Brien PC, Yang F, O'Brien SJ, Ferguson-Smith MA. Conservation of human vs. feline genome organization revealed by reciprocal chromosome painting. Cytogenet Cell Genet. 1997;77(3-4):211-7. doi: 10.1159/000134579."}, {'type': 'BACKGROUND', 'citation': 'Pittman PR, Martin JW, Kingebeni PM, Tamfum J-JM, Wan Q, Reynolds MG, et al. Clinical characterization of human monkeypox infections in the Democratic Republic of the Congo. medRxiv. 2022:2022.05.26.22273379.'}, {'type': 'BACKGROUND', 'citation': 'Product Development Under the Animal Rule - Guidance for Industry, FDA October 2015: https://www.fda.gov/media/88625/download, accessed 6-9-2022'}, {'pmid': '2941342', 'type': 'BACKGROUND', 'citation': "Kuznetsov VG. [Contamination of vegetables and the external environment of vegetable store houses of the Primor'e Territory by Yersinia]. Gig Sanit. 1986 May;(5):69-71. No abstract available. Russian."}, {'pmid': '16908354', 'type': 'BACKGROUND', 'citation': 'Sale TA, Melski JW, Stratman EJ. Monkeypox: an epidemiologic and clinical comparison of African and US disease. J Am Acad Dermatol. 2006 Sep;55(3):478-81. doi: 10.1016/j.jaad.2006.05.061.'}, {'pmid': '35904001', 'type': 'BACKGROUND', 'citation': 'Siegrist EA, Sassine J. Antivirals With Activity Against Mpox: A Clinically Oriented Review. Clin Infect Dis. 2023 Jan 6;76(1):155-164. doi: 10.1093/cid/ciac622.'}, {'pmid': '2650551', 'type': 'BACKGROUND', 'citation': "Cushing M. Who's responsible for too-early discharge? Am J Nurs. 1989 Apr;89(4):471-2. No abstract available."}, {'pmid': '35952705', 'type': 'BACKGROUND', 'citation': 'Tarin-Vicente EJ, Alemany A, Agud-Dios M, Ubals M, Suner C, Anton A, Arando M, Arroyo-Andres J, Calderon-Lozano L, Casan C, Cabrera JM, Coll P, Descalzo V, Folgueira MD, Garcia-Perez JN, Gil-Cruz E, Gonzalez-Rodriguez B, Gutierrez-Collar C, Hernandez-Rodriguez A, Lopez-Roa P, de Los Angeles Melendez M, Montero-Menarguez J, Munoz-Gallego I, Palencia-Perez SI, Paredes R, Perez-Rivilla A, Pinana M, Prat N, Ramirez A, Rivero A, Rubio-Muniz CA, Vall M, Acosta-Velasquez KS, Wang A, Galvan-Casas C, Marks M, Ortiz-Romero PL, Mitja O. Clinical presentation and virological assessment of confirmed human monkeypox virus cases in Spain: a prospective observational cohort study. Lancet. 2022 Aug 27;400(10353):661-669. doi: 10.1016/S0140-6736(22)01436-2. Epub 2022 Aug 8.'}, {'pmid': '35866746', 'type': 'BACKGROUND', 'citation': 'Thornhill JP, Barkati S, Walmsley S, Rockstroh J, Antinori A, Harrison LB, Palich R, Nori A, Reeves I, Habibi MS, Apea V, Boesecke C, Vandekerckhove L, Yakubovsky M, Sendagorta E, Blanco JL, Florence E, Moschese D, Maltez FM, Goorhuis A, Pourcher V, Migaud P, Noe S, Pintado C, Maggi F, Hansen AE, Hoffmann C, Lezama JI, Mussini C, Cattelan A, Makofane K, Tan D, Nozza S, Nemeth J, Klein MB, Orkin CM; SHARE-net Clinical Group. Monkeypox Virus Infection in Humans across 16 Countries - April-June 2022. N Engl J Med. 2022 Aug 25;387(8):679-691. doi: 10.1056/NEJMoa2207323. Epub 2022 Jul 21.'}, {'type': 'BACKGROUND', 'citation': 'WHO fact sheet: www.who.int/news-room/fact-sheets/detail/monkeypox, accessed 6-9-2022'}, {'pmid': '1235851', 'type': 'BACKGROUND', 'citation': 'I.G. stimulants of the central nervous system. Behav Neuropsychiatry. 1975 Apr-1976 Mar;7(1-12):79-80. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled double-blind clinical trial is to test the drug tecovirimat in patients with mpox (previously known as monkeypox) disease.\n\nThe main questions it aims to answer are:\n\n* Is tecovirimat effective in treating mpox infection.\n* Is tecovirimat safe to treat patients with mpox infection.\n\nParticipants will receive either the drug tecovirimat orally, 600 mg twice per day, or a matching placebo. The outcome of the infection and the side effect experienced will be compared between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Polymerase Chain Reaction (PCR) /Nucleic Acid Amplification Test (NAAT) -confirmed mpox infection\n* The presence of active skin or mucosal lesion(s)\n* Signed Informed Consent Form\n\nExclusion Criteria:\n\n* Age \\<18 years.\n* Body weight \\<40 kg\n* Pregnant and breastfeeding patients are not eligible for inclusion in this study.\n* Lack of mental capacity to provide informed consent\n* Trial participation is considered not in the best interest of patient\n* Known hypersensitivity to the active substance or to any of the excipients of the study drug.\n* Use of contraindicated treatment repaglinide. (Repaglinide, an oral treatment for diabetes mellitus, may be discontinued while taking study treatment with the agreement of the patient's general practitioner, who may start alternate diabetes treatment if considered necessary.)\n* Previous, current or planned use of another investigational drug (tecovirimat) at any point during study participation.\n* The patient's own doctor considers there to be a definite indication for the patient to receive tecovirimat or the local guidelines establish that tecovirimat treatment should be initiated\n* The patient's own doctor considers there to be a definite contraindication to the patient receiving tecovirimat.\n* The patient suffers from hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption."}, 'identificationModule': {'nctId': 'NCT06156566', 'acronym': 'EPOXI', 'briefTitle': 'European Trial Into Mpox Infection', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'European Randomised Clinical Trial on mPOX Infection', 'orgStudyIdInfo': {'id': '2022-501979-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tecovirimat', 'description': 'Oral treatment with tecovirimat 200 mg capsules. Twice daily three capsules orally. Duration of treatment: 14 days (28 administrations).', 'interventionNames': ['Drug: Tecovirimat Oral Capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo to tecovirimat capsules. Twice daily three capsules orally. Duration of treatment: 14 days (28 administrations).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tecovirimat Oral Capsule', 'type': 'DRUG', 'otherNames': ['Tpoxx Tecovirimat'], 'description': '600 mg, twice daily, 14 days.', 'armGroupLabels': ['Tecovirimat']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Oral placebo capsule'], 'description': '3 capsules, twice daily, 14 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Antwerp', 'state': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Laurens Liesenborghs, MD', 'role': 'CONTACT'}, {'name': 'Laurens Liesenborghs, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Tropical Medicine', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1200', 'city': 'Brussels', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Leila Belkhir, Prof', 'role': 'CONTACT'}, {'name': 'Leila Belkhir, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cliniques Universitaires St. Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '75010', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Michel Molina, Prof', 'role': 'CONTACT'}, {'name': 'Jean Michel Molina, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP St. Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '53127', 'city': 'Bonn', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christoph Boesecke', 'role': 'CONTACT'}, {'name': 'Christoph Boesecke', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuliano Rizzardini', 'role': 'CONTACT'}, {'name': 'Giuliano Rizzardini', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Luigi Sacco', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Verona', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Evelina Tacconelli', 'role': 'CONTACT'}, {'name': 'Evelina Tacconelli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera Universitaria Integrata Verona - AOUI Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Amsterdam', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Abraham Goorhuis', 'role': 'CONTACT'}, {'name': 'Abraham Goorhuis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Amsterdam UMC - AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '0450', 'city': 'Oslo', 'status': 'NOT_YET_RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Frank Olav Dahler Pettersen, Dr', 'role': 'CONTACT'}, {'name': 'Frank Olav Dahler Pettersen, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oslo Unversity Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '1169-050', 'city': 'Lisbon', 'status': 'NOT_YET_RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Cândida Fernandes, MD', 'role': 'CONTACT'}, {'name': 'Cândida Fernandes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Santo António dos Capuchos', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '28040', 'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Vicente Estrada', 'role': 'CONTACT'}, {'name': 'Vicente Estrada', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose I Bernardino', 'role': 'CONTACT'}, {'name': 'Jose I Bernardino', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41009', 'city': 'Seville', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Miguel Nicolas Navarrete Lorite, Dr', 'role': 'CONTACT'}, {'name': 'Miguel Nicolas Navarrete Lorite, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Miquel B Ekkelenkamp, MD, PhD', 'role': 'CONTACT', 'email': 'm.ekkelenkamp@umcutrecht.nl', 'phone': '+31643217087'}, {'name': 'Lina Gurskaite', 'role': 'CONTACT', 'email': 'lina.gurskaite@ecraid.eu', 'phone': '+31631117890'}], 'overallOfficials': [{'name': 'Miquel B Ekkelenkamp, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Miquel Ekkelenkamp', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Clinical Research Alliance for Infectious Diseases (ECRAID)', 'class': 'OTHER'}, {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Microbiologist', 'investigatorFullName': 'Miquel Ekkelenkamp', 'investigatorAffiliation': 'UMC Utrecht'}}}}