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

August 12, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

The Role of Polymerase Chain Reaction in the Management of Patients With Infective Endocarditis: Modern Diagnostic and Therapeutic Concepts

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;

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study protocol is divided into four different phases:screening, pre-operative clinical assessment (T-1), cardiac surgery (T0) and follow-up period (T4 eT90).

During the screening phase, patients will be assessed to determine whether they met the study inclusion/exclusion criteria. After signing the informed consent, patients will go through a preoperative clinical evaluation (T-1). The following assessments are carried out the day before surgery: recording patient's generality, present antibiotic therapy and possible results of blood cultures performed prior to recruitment; - Twelve-lead ECG; - chest X-ray - transthoracic echocardiogram (TTE); -. three pairs of blood cultures from three different blood sampling sites. In cases of complicated endocarditis, the presence and location of septic embolisms is recorded (using Total body CT scan imaging), signs of heart failure evaluated and operability criteria are assessed. On the day of cardiac surgery (T0), main intraoperative data (valve findings, type of prosthesis, surgery time, cardiopulmonary bypass time and aortic cross clamping time) will be gathered; the excised valve was sent partly to the microbiology laboratory for culture and molecular tests and partly to the pathology Laboratory.

After cardiac surgery, patients continued to be monitored for a follow up at four (T4) and 90 (T90) days after surgery. During the follow-up period, information was collected on the patient's clinical status (vital parameters) and the antibiotic treatment performed. The same blood tests performed at T-1 are repeated at T4 and T90. All this data was recorded on a dedicated database.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Policlinico Agostino Gemelli
      • Roma, Italy, 00168
        • IRCCS Fondazione Policlinico Universitario Agostino Gemelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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).
  2. patients who have signed informed consent to the partecipation of the study

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endocarditis patients
Patients with endocarditis who respect including criteria
Diagnostic test: PCR (Polymerase Chain Reaction) targeting the 16 ribosomal DNA
Molecular diagnostic using a broad range PCR on obtained histological material (native valve/valve prosthesis/fragments of them)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of molecular diagnostic tests on the identification of microorganisms
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
number of microorganism isolated through molecular diagnostic tests
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of molecular diagnostic tests on antibiotic therapy
Time Frame: through study completion, an average of 1 year
Number of patients with IE in which antibiotic therapy change because of the results of molecular diagnostic tests
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Massimo Massetti, Fondazione Universitaria Policliino Gemelli IRCSS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3451

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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