NCT05791357

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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;

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.

Conditions

• Endocarditis Infective

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-04-01
• Primary completion: 2024-05-31
• Completion: 2024-10-31
• First posted: 2023-03-30
• Last updated: 2025-08-15

Locations

2 sites across 1 country: Italy