The Role of Polymerase Chain Reaction in the Management of Patients With Infective Endocarditis

NCT05791357 | Completed

• 1 other identifier: 3451
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to prospectively investigate the additional diagnostic value of broad range PCR targeting the 16 ribosomal DNA in diagnosis and management of patients with infective endocarditis who are candidate for surgicaltherapy;

Conditions

Endocarditis Infective

Outcome Measures

Primary Outcomes (2)

• Impact of molecular diagnostic tests on the identification of microorganisms

  number of patients with positive blood cultures vs number of patients with negative blood cultures but with positive molecular diagnostic tests

  through study completion, an average of 1 year

• number of microorganism isolated

  number of microorganism isolated through molecular diagnostic tests

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Impact of molecular diagnostic tests on antibiotic therapy

  through study completion, an average of 1 year

Study Arms (1)

Endocarditis patients

EXPERIMENTAL

Patients with endocarditis who respect including criteria

Diagnostic Test: PCR (Polymerase Chain Reaction) targeting the 16 ribosomal DNA

Interventions

PCR (Polymerase Chain Reaction) targeting the 16 ribosomal DNA DIAGNOSTIC_TEST

Molecular diagnostic using a broad range PCR on obtained histological material (native valve/valve prosthesis/fragments of them)

Endocarditis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients older than 18 years, with diagnosis of IE on a native or prosthetic valve and with a surgical indication for heart valve replacement using extracorporeal circulation (CPB).
• patients who have signed informed consent to the partecipation of the study

You may not qualify if:

• patients younger than 18 years
• Failure to sign consent for personal data processing and/or study participation
• Participation in other experimental studies
• Patients who did not complete the examinations under study (culture test on blood and excised valve, molecular tests)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (2)

IRCCS Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

Policlinico Agostino Gemelli

Roma, 00168, Italy

Location

Related Publications (17)

• Cahill TJ, Baddour LM, Habib G, Hoen B, Salaun E, Pettersson GB, Schafers HJ, Prendergast BD. Challenges in Infective Endocarditis. J Am Coll Cardiol. 2017 Jan 24;69(3):325-344. doi: 10.1016/j.jacc.2016.10.066.

  PMID: 28104075 BACKGROUND

• Habib G, Lancellotti P, Antunes MJ, Bongiorni MG, Casalta JP, Del Zotti F, Dulgheru R, El Khoury G, Erba PA, Iung B, Miro JM, Mulder BJ, Plonska-Gosciniak E, Price S, Roos-Hesselink J, Snygg-Martin U, Thuny F, Tornos Mas P, Vilacosta I, Zamorano JL; ESC Scientific Document Group. 2015 ESC Guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM). Eur Heart J. 2015 Nov 21;36(44):3075-3128. doi: 10.1093/eurheartj/ehv319. Epub 2015 Aug 29. No abstract available.

  PMID: 26320109 BACKGROUND

• Baddour LM, Wilson WR, Bayer AS, Fowler VG Jr, Tleyjeh IM, Rybak MJ, Barsic B, Lockhart PB, Gewitz MH, Levison ME, Bolger AF, Steckelberg JM, Baltimore RS, Fink AM, O'Gara P, Taubert KA; American Heart Association Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and Stroke Council. Infective Endocarditis in Adults: Diagnosis, Antimicrobial Therapy, and Management of Complications: A Scientific Statement for Healthcare Professionals From the American Heart Association. Circulation. 2015 Oct 13;132(15):1435-86. doi: 10.1161/CIR.0000000000000296. Epub 2015 Sep 15.

  PMID: 26373316 BACKGROUND

• Pant S, Patel NJ, Deshmukh A, Golwala H, Patel N, Badheka A, Hirsch GA, Mehta JL. Trends in infective endocarditis incidence, microbiology, and valve replacement in the United States from 2000 to 2011. J Am Coll Cardiol. 2015 May 19;65(19):2070-6. doi: 10.1016/j.jacc.2015.03.518.

  PMID: 25975469 BACKGROUND

• Habib G, Lancellotti P, Erba PA, Sadeghpour A, Meshaal M, Sambola A, Furnaz S, Citro R, Ternacle J, Donal E, Cosyns B, Popescu B, Iung B, Prendergast B, Laroche C, Tornos P, Pazdernik M, Maggioni A, Gale CP; EURO-ENDO Investigators. The ESC-EORP EURO-ENDO (European Infective Endocarditis) registry. Eur Heart J Qual Care Clin Outcomes. 2019 Jul 1;5(3):202-207. doi: 10.1093/ehjqcco/qcz018.

  PMID: 30957862 BACKGROUND

• Habib G, Erba PA, Iung B, Donal E, Cosyns B, Laroche C, Popescu BA, Prendergast B, Tornos P, Sadeghpour A, Oliver L, Vaskelyte JJ, Sow R, Axler O, Maggioni AP, Lancellotti P; EURO-ENDO Investigators. Clinical presentation, aetiology and outcome of infective endocarditis. Results of the ESC-EORP EURO-ENDO (European infective endocarditis) registry: a prospective cohort study. Eur Heart J. 2019 Oct 14;40(39):3222-3232. doi: 10.1093/eurheartj/ehz620.

  PMID: 31504413 BACKGROUND

• Dickerman SA, Abrutyn E, Barsic B, Bouza E, Cecchi E, Moreno A, Doco-Lecompte T, Eisen DP, Fortes CQ, Fowler VG Jr, Lerakis S, Miro JM, Pappas P, Peterson GE, Rubinstein E, Sexton DJ, Suter F, Tornos P, Verhagen DW, Cabell CH; ICE Investigators. The relationship between the initiation of antimicrobial therapy and the incidence of stroke in infective endocarditis: an analysis from the ICE Prospective Cohort Study (ICE-PCS). Am Heart J. 2007 Dec;154(6):1086-94. doi: 10.1016/j.ahj.2007.07.023. Epub 2007 Sep 12.

  PMID: 18035080 BACKGROUND

• Nihoyannopoulos P, Oakley CM, Exadactylos N, Ribeiro P, Westaby S, Foale RA. Duration of symptoms and the effects of a more aggressive surgical policy: two factors affecting prognosis of infective endocarditis. Eur Heart J. 1985 May;6(5):380-90. doi: 10.1093/oxfordjournals.eurheartj.a061876.

  PMID: 4043095 BACKGROUND

• Lodise TP, McKinnon PS, Swiderski L, Rybak MJ. Outcomes analysis of delayed antibiotic treatment for hospital-acquired Staphylococcus aureus bacteremia. Clin Infect Dis. 2003 Jun 1;36(11):1418-23. doi: 10.1086/375057. Epub 2003 May 20.

  PMID: 12766837 BACKGROUND

• Shrestha NK, Ledtke CS, Wang H, Fraser TG, Rehm SJ, Hussain ST, Pettersson GB, Blackstone EH, Gordon SM. Heart valve culture and sequencing to identify the infective endocarditis pathogen in surgically treated patients. Ann Thorac Surg. 2015 Jan;99(1):33-7. doi: 10.1016/j.athoracsur.2014.07.028. Epub 2014 Oct 22.

  PMID: 25442997 BACKGROUND

• Morris AJ, Drinkovic D, Pottumarthy S, Strickett MG, MacCulloch D, Lambie N, Kerr AR. Gram stain, culture, and histopathological examination findings for heart valves removed because of infective endocarditis. Clin Infect Dis. 2003 Mar 15;36(6):697-704. doi: 10.1086/367842. Epub 2003 Mar 4.

  PMID: 12627353 BACKGROUND

• Lamas CC, Fournier PE, Zappa M, Brandao TJ, Januario-da-Silva CA, Correia MG, Barbosa GI, Golebiovski WF, Weksler C, Lepidi H, Raoult D. Diagnosis of blood culture-negative endocarditis and clinical comparison between blood culture-negative and blood culture-positive cases. Infection. 2016 Aug;44(4):459-66. doi: 10.1007/s15010-015-0863-x. Epub 2015 Dec 15.

  PMID: 26670038 BACKGROUND

• Zegri-Reiriz I, de Alarcon A, Munoz P, Martinez Selles M, Gonzalez-Ramallo V, Miro JM, Falces C, Gonzalez Rico C, Kortajarena Urkola X, Lepe JA, Rodriguez Alvarez R, Reguera Iglesias JM, Navas E, Dominguez F, Garcia-Pavia P; Spanish Collaboration on Endocarditis-Grupo de Apoyo al Manejo de la Endocarditis infecciosa en Espana (GAMES). Infective Endocarditis in Patients With Bicuspid Aortic Valve or Mitral Valve Prolapse. J Am Coll Cardiol. 2018 Jun 19;71(24):2731-2740. doi: 10.1016/j.jacc.2018.03.534.

  PMID: 29903346 BACKGROUND

• Fontana C, Favaro M, Pelliccioni M, Pistoia ES, Favalli C. Use of the MicroSeq 500 16S rRNA gene-based sequencing for identification of bacterial isolates that commercial automated systems failed to identify correctly. J Clin Microbiol. 2005 Feb;43(2):615-9. doi: 10.1128/JCM.43.2.615-619.2005.

  PMID: 15695654 BACKGROUND

• Mignard S, Flandrois JP. 16S rRNA sequencing in routine bacterial identification: a 30-month experiment. J Microbiol Methods. 2006 Dec;67(3):574-81. doi: 10.1016/j.mimet.2006.05.009. Epub 2006 Jul 21.

  PMID: 16859787 BACKGROUND

• Akram A, Maley M, Gosbell I, Nguyen T, Chavada R. Utility of 16S rRNA PCR performed on clinical specimens in patient management. Int J Infect Dis. 2017 Apr;57:144-149. doi: 10.1016/j.ijid.2017.02.006. Epub 2017 Feb 16.

  PMID: 28216180 BACKGROUND

• Pavone N, Cammertoni F, Calabrese M, Bruno P, Scoppettuolo G, Lombardo A, Giovannenze F, Taddei E, Fiori B, D'Inzeo T, Cutrone G, Iannaccone G, Del Zanna N, Massetti M. The expanding role of 16s ribosomal RNA PCR in the management of patients with infective endocarditis undergoing cardiac surgery. Front Cardiovasc Med. 2024 Dec 18;11:1504197. doi: 10.3389/fcvm.2024.1504197. eCollection 2024.

  PMID: 39744206 DERIVED

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Massimo Massetti

  Fondazione Universitaria Policliino Gemelli IRCSS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 30, 2023
• Study Start: April 1, 2020
• Primary Completion: May 31, 2024
• Study Completion: October 31, 2024
• Last Updated: August 15, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)