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Oral antimicrobial treatment vs. outpatient parenteral for infective endocarditis
EU CTIS ID: 2024-519969-21-00
What this study is testing
To demonstrate the non-inferiority of outpatient oral antibiotic therapy in comparison with outpatient parenteral antibiotic treatment (OPAT)
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Left-sided native or prosthetic infective endocarditis based on the modified Duke criteria infected with one of the following nonresistant microorganisms: Non-resistant streptococci and other gram positive cocci,e.g., Granulicatella and Abiotrophia; Enterococcus faecalis; Staphylococcus aureus;coagulase-negative staphylococci and HACEK group.
- Male or female 18 years old or older.
- ≥10 days of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after valve surgery
- T<38.0° C for more than two days
- C-reactive protein dropped below 25% of the peak value or below an absolute value of 20 mg/L, and the white blood cell count dropped to less than 15 × 10(9)/L during antibiotic treatment
- No sign of abscess formation revealed by echocardiography
You likely can't join if
- Body mass index >40
- Women in lactancy period
- Concomitant infection requiring intravenous antibiotic therapy
- Inability to give informed consent to participation
- Suspicion of reduced absorption of oral treatment due to abdominal disorder
- Microorganisms other than those defined in inclusion criteria
See the full eligibility criteria
- Left-sided native or prosthetic infective endocarditis based on the modified Duke criteria infected with one of the following nonresistant microorganisms: Non-resistant streptococci and other gram positive cocci,e.g., Granulicatella and Abiotrophia; Enterococcus faecalis; Staphylococcus aureus;coagulase-negative staphylococci and HACEK group.
- Male or female 18 years old or older.
- ≥10 days of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after valve surgery
- T<38.0° C for more than two days
- C-reactive protein dropped below 25% of the peak value or below an absolute value of 20 mg/L, and the white blood cell count dropped to less than 15 × 10(9)/L during antibiotic treatment
- No sign of abscess formation revealed by echocardiography
- Transthoracic/transesophageal echocardiography performed preferably within 48 h of randomization. Ecoscopy or portable echocardiogram are also admitted, as long as they are registered on the clinical history.
- Body mass index >40
- Women in lactancy period
- Concomitant infection requiring intravenous antibiotic therapy
- Inability to give informed consent to participation
- Suspicion of reduced absorption of oral treatment due to abdominal disorder
- Microorganisms other than those defined in inclusion criteria
- Any immunosuppressive disease or any medical condition at the discretion of the investigator that may preclude oral or OPAT therapy
- No family or appropriate home support
- Reduced compliance
- Women of childbearing potential with a positive pregnancy test, or participants (male or female) who wish to plan a pregnancy during the trial period.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.