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NCT Number: NCT05791357

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

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;

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Fondazione Policlinico Universitario Agostino Gemelli, Roma, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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)

Primary outcomes

  1. 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

  2. number of microorganism isolated

    Time frame: through study completion, an average of 1 year

    number of microorganism isolated through molecular diagnostic tests

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 30, 2023
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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