Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT04070820
Status:
UNKNOWN
Last Update Posted:
2020-03-25
First Post:
2019-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Treatment for Enterococcus Faecalis Bacteriemia Multicenter, Observational Study"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D004696', 'term': 'Endocarditis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'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': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-23', 'studyFirstSubmitDate': '2019-08-22', 'studyFirstSubmitQcDate': '2019-08-24', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'End of Treatment, at least 2 weeks from first negative follow-up bloodculture', 'description': 'Patient alive'}, {'measure': 'Body temperature (Celsius degrees)', 'timeFrame': 'End of Treatment, at least 2 weeks from first negative follow-up bloodculture', 'description': 'Fever resolution'}, {'measure': 'Sequential Organ Failure Assessment (SOFA) Score', 'timeFrame': 'End of Treatment, at least 2 weeks from first negative follow-up bloodculture', 'description': 'Stable or improved SOFA score. Total SOFA score ranges from 0 to 24 points. Total SOFA score consist of the sum of individual score of following items: Respiratory System (PaO2/FiO2), Cardiovascular system (Mean Arterial Pressure or administration vasopressure required), Newrvous System (Glasgow Coma Scale), Liver (bilirubin), Coagulation (platelets), Kidneys (creatinine). Each items receive a score ranging from 0 to 4 pt.'}, {'measure': 'Blood cultures', 'timeFrame': 'End of Treatment, at least 2 weeks from first negative follow-up bloodculture', 'description': 'Follow-up Blood cultures negative for E. faecalis'}, {'measure': 'Blood cultures', 'timeFrame': '90 days from End of Treatment', 'description': 'No relapse of EF-BSI'}, {'measure': 'Antibiotic therapy', 'timeFrame': '90 days from End of Treatment', 'description': 'No need to modify initial therapy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Combination therapy', 'Bloodstream Infection', 'Enterococcus faecalis Infection', 'Endocarditis'], 'conditions': ['Enterococcal Bacteraemia', 'Enterococcus Faecalis Infection', 'Enterococcal Endocarditis', 'Bloodstream Infection']}, 'referencesModule': {'references': [{'pmid': '15306996', 'type': 'BACKGROUND', 'citation': 'Wisplinghoff H, Bischoff T, Tallent SM, Seifert H, Wenzel RP, Edmond MB. Nosocomial bloodstream infections in US hospitals: analysis of 24,179 cases from a prospective nationwide surveillance study. Clin Infect Dis. 2004 Aug 1;39(3):309-17. doi: 10.1086/421946. Epub 2004 Jul 15.'}, {'pmid': '19845694', 'type': 'BACKGROUND', 'citation': 'Rodriguez-Bano J, Lopez-Prieto MD, Portillo MM, Retamar P, Natera C, Nuno E, Herrero M, del Arco A, Munoz A, Tellez F, Torres-Tortosa M, Martin-Aspas A, Arroyo A, Ruiz A, Moya R, Corzo JE, Leon L, Perez-Lopez JA; SAEI/SAMPAC Bacteraemia Group. Epidemiology and clinical features of community-acquired, healthcare-associated and nosocomial bloodstream infections in tertiary-care and community hospitals. Clin Microbiol Infect. 2010 Sep;16(9):1408-13. doi: 10.1111/j.1469-0691.2009.03089.x.'}, {'pmid': '26341945', 'type': 'BACKGROUND', 'citation': 'Cahill TJ, Prendergast BD. Infective endocarditis. Lancet. 2016 Feb 27;387(10021):882-93. doi: 10.1016/S0140-6736(15)00067-7. Epub 2015 Sep 1.'}, {'pmid': '22612464', 'type': 'BACKGROUND', 'citation': 'Reigadas E, Rodriguez-Creixems M, Guembe M, Sanchez-Carrillo C, Martin-Rabadan P, Bouza E. Catheter-related bloodstream infection caused by Enterococcus spp. Clin Microbiol Infect. 2013 May;19(5):457-61. doi: 10.1111/j.1469-0691.2012.03897.x. Epub 2012 May 22.'}, {'pmid': '23517406', 'type': 'BACKGROUND', 'citation': 'Chirouze C, Athan E, Alla F, Chu VH, Ralph Corey G, Selton-Suty C, Erpelding ML, Miro JM, Olaison L, Hoen B; International Collaboration on Endocarditis Study Group. Enterococcal endocarditis in the beginning of the 21st century: analysis from the International Collaboration on Endocarditis-Prospective Cohort Study. Clin Microbiol Infect. 2013 Dec;19(12):1140-7. doi: 10.1111/1469-0691.12166. Epub 2013 Mar 20.'}, {'pmid': '19916034', 'type': 'BACKGROUND', 'citation': 'McBride SJ, Upton A, Roberts SA. Clinical characteristics and outcomes of patients with vancomycin-susceptible Enterococcus faecalis and Enterococcus faecium bacteraemia--a five-year retrospective review. Eur J Clin Microbiol Infect Dis. 2010 Jan;29(1):107-14. doi: 10.1007/s10096-009-0830-5. Epub 2009 Nov 15.'}, {'pmid': '7963458', 'type': 'BACKGROUND', 'citation': 'Gray J, Marsh PJ, Stewart D, Pedler SJ. Enterococcal bacteraemia: a prospective study of 125 episodes. J Hosp Infect. 1994 Jul;27(3):179-86. doi: 10.1016/0195-6701(94)90125-2.'}, {'pmid': '20946408', 'type': 'BACKGROUND', 'citation': 'Suppli M, Aabenhus R, Harboe ZB, Andersen LP, Tvede M, Jensen JU. Mortality in enterococcal bloodstream infections increases with inappropriate antimicrobial therapy. Clin Microbiol Infect. 2011 Jul;17(7):1078-83. doi: 10.1111/j.1469-0691.2010.03394.x. Epub 2010 Dec 3.'}, {'pmid': '25118271', 'type': 'BACKGROUND', 'citation': "Foo H, Chater M, Maley M, van Hal SJ. Glycopeptide use is associated with increased mortality in Enterococcus faecalis bacteraemia--authors' response. J Antimicrob Chemother. 2014 Nov;69(11):3166. doi: 10.1093/jac/dku329. Epub 2014 Aug 12. No abstract available."}, {'pmid': '23398607', 'type': 'BACKGROUND', 'citation': 'Cheah AL, Spelman T, Liew D, Peel T, Howden BP, Spelman D, Grayson ML, Nation RL, Kong DC. Enterococcal bacteraemia: factors influencing mortality, length of stay and costs of hospitalization. Clin Microbiol Infect. 2013 Apr;19(4):E181-9. doi: 10.1111/1469-0691.12132. Epub 2013 Feb 7.'}, {'pmid': '19489710', 'type': 'BACKGROUND', 'citation': "Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376."}, {'pmid': '2404568', 'type': 'BACKGROUND', 'citation': 'Murray BE. The life and times of the Enterococcus. Clin Microbiol Rev. 1990 Jan;3(1):46-65. doi: 10.1128/CMR.3.1.46.'}, {'pmid': '17438316', 'type': 'BACKGROUND', 'citation': 'Gavalda J, Len O, Miro JM, Munoz P, Montejo M, Alarcon A, de la Torre-Cisneros J, Pena C, Martinez-Lacasa X, Sarria C, Bou G, Aguado JM, Navas E, Romeu J, Marco F, Torres C, Tornos P, Planes A, Falco V, Almirante B, Pahissa A. Brief communication: treatment of Enterococcus faecalis endocarditis with ampicillin plus ceftriaxone. Ann Intern Med. 2007 Apr 17;146(8):574-9. doi: 10.7326/0003-4819-146-8-200704170-00008.'}, {'pmid': '3134590', 'type': 'BACKGROUND', 'citation': 'Maki DG, Agger WA. Enterococcal bacteremia: clinical features, the risk of endocarditis, and management. Medicine (Baltimore). 1988 Jul;67(4):248-69.'}, {'pmid': '12356804', 'type': 'BACKGROUND', 'citation': 'Sandoe JA, Witherden IR, Au-Yeung HK, Kite P, Kerr KG, Wilcox MH. Enterococcal intravascular catheter-related bloodstream infection: management and outcome of 61 consecutive cases. J Antimicrob Chemother. 2002 Oct;50(4):577-82. doi: 10.1093/jac/dkf182.'}, {'pmid': '26082503', 'type': 'BACKGROUND', 'citation': 'Ibrahim SL, Zhang L, Brady TM, Hsu AJ, Cosgrove SE, Tamma PD. Low-dose Gentamicin for Uncomplicated Enterococcus faecalis Bacteremia May be Nephrotoxic in Children. Clin Infect Dis. 2015 Oct 1;61(7):1119-24. doi: 10.1093/cid/civ461. Epub 2015 Jun 16.'}, {'pmid': '29397537', 'type': 'BACKGROUND', 'citation': 'Diallo K, Kern WV, de With K, Luc A, Thilly N, Pulcini C; ESGAP and ESGBIS. Management of bloodstream infections by infection specialists in France and Germany: a cross-sectional survey. Infection. 2018 Jun;46(3):333-339. doi: 10.1007/s15010-018-1122-8. Epub 2018 Feb 3.'}, {'pmid': '29309899', 'type': 'BACKGROUND', 'citation': 'Diallo K, Thilly N, Luc A, Beraud G, Ergonul O, Giannella M, Kofteridis D, Kostyanev T, Pano-Pardo JR, Retamar P, Kern W, Pulcini C; ESGAP, ESGBIS. Management of bloodstream infections by infection specialists: an international ESCMID cross-sectional survey. Int J Antimicrob Agents. 2018 May;51(5):794-798. doi: 10.1016/j.ijantimicag.2017.12.010. Epub 2018 Jan 5.'}, {'pmid': '25381321', 'type': 'BACKGROUND', 'citation': 'Bouza E, Kestler M, Beca T, Mariscal G, Rodriguez-Creixems M, Bermejo J, Fernandez-Cruz A, Fernandez-Aviles F, Munoz P; Grupo de Apoyo al Manejo de la Endocarditis. The NOVA score: a proposal to reduce the need for transesophageal echocardiography in patients with enterococcal bacteremia. Clin Infect Dis. 2015 Feb 15;60(4):528-35. doi: 10.1093/cid/ciu872. Epub 2014 Nov 7.'}, {'pmid': '12435215', 'type': 'BACKGROUND', 'citation': 'Friedman ND, Kaye KS, Stout JE, McGarry SA, Trivette SL, Briggs JP, Lamm W, Clark C, MacFarquhar J, Walton AL, Reller LB, Sexton DJ. Health care--associated bloodstream infections in adults: a reason to change the accepted definition of community-acquired infections. Ann Intern Med. 2002 Nov 19;137(10):791-7. doi: 10.7326/0003-4819-137-10-200211190-00007.'}, {'pmid': '26903338', 'type': 'BACKGROUND', 'citation': 'Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, multicenter, observational study on the evaluation of efficacy of appropriate monotherapy vs combination treatment for non-complicated Enterococcus faecalis bloodstream infection (EF-BSI).\n\nThe aims of our study are:\n\nPrimary:\n\nTo compare the efficacy of appropriate monotherapy vs combination treatment for EF-BSI, according to standard of care.\n\nSecondary:\n\n1. To compare the impact on clinical outcome of the initial combination therapy in the subgroup of patients with enterococcal endocarditis. In this case we will evaluate only the antibiotic treatment administered before the diagnosis of endocarditis assuming that any case of endocarditis will be treated with a combination therapy.\n2. To compare the efficacy of combination treatment (vs monotherapy) in the following subgroup of patients:\n\n A. Patients with low versus high risk of endocarditis according with the "Number of positive blood cultures, Origin of the bacteremia, previous Valve disease, Auscultation of heart murmur (NOVA) score".\n\n B. Patients with metastatic septic localizations. C. Patients with catheter-related BSI. D. Patients with indwelling cardiovascular device or prosthetic valve.\n3. To validate the NOVA score as a predictor of enterococcal endocarditis in a large multicentre cohort of patients with EF-BSI.\n4. To estimate optimal duration of treatment of EF-BSI in patients without endocarditis.\n5. To evaluate the rate of 90-day development of Clostridium difficile infection.\n\nThe promoting center is S. Orsola-Malpighi Hospital is a 1,420-bed tertiary care University Hospital in Bologna with an average of 72,000 admissions per year. A dedicate team of Infectious Diseases (ID) specialists is active in the promoting center. Investigators of this team have already coordinated multicenter studies on infections topics. Centers from other countries will be invited to participate by email, they will be ask to fulfil an agreement form.\n\nAll consecutive, unselected patients with monomicrobial EF-BSI will be screened for study inclusion. We expect to enroll about 500 patients.\n\nPeriod of data collection will be from september 2019 to 31th December 2020.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive, unselected patients with a first episode of monomicrobial EF-BSI will be screened for study inclusion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (\\>18 years)\n* First monomicrobial EF-BSI\n* Receipt of ≥ 5 days of at least one in vitro active drug (ampicillin, amoxicillin/clavulanate, ampicillin/sulbactam, piperacillin, vancomycin, teicoplanin, daptomycin and linezolid) with or without a synergistic drug (ceftriaxone, gentamycin, streptomycin), at common suggested dosages for EF-BSI in empirical or definitive therapy\n* Written informed consent\n\nExclusion Criteria:\n\n* Short term (within 3 days from BSI) mortality\n* Other concomitant infection'}, 'identificationModule': {'nctId': 'NCT04070820', 'briefTitle': 'Combination Treatment for Enterococcus Faecalis Bacteriemia Multicenter, Observational Study"', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': '"Combination Treatment for Enterococcus Faecalis Bacteremia: a Prospective, Multicenter, Observational Study"', 'orgStudyIdInfo': {'id': 'EfFAECT'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Bartoletti', 'role': 'CONTACT'}], 'facility': 'Infectious Disease Unit - S.Orsola Malpighi Hospital', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Michele Bartoletti', 'role': 'CONTACT', 'email': 'm.bartoletti@unibo.it', 'phone': '0512143199'}, {'name': 'Elena Rosselli Del Turco', 'role': 'CONTACT', 'email': 'elena.rosselli@studio.unibo.it', 'phone': '0512142861'}], 'overallOfficials': [{'name': 'Michele Bartoletti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dipartimento di Scienze mediche e chirurgiche, Alma Mater-University of Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Michele Bartoletti', 'investigatorAffiliation': 'University of Bologna'}}}}