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Study Comparing Oral Amoxicillin to Outpatient IV Antibiotics for Patients with Infective Endocarditis

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as infective endocarditis, which is an infection of the inner lining of the heart chambers and valves. The study is comparing two different ways of treating this infection: using oral antibiotics and using antibiotics given through a vein, known as parenteral treatment. The oral antibiotic being used in this study is amoxicillin, which is a common medication used to treat various bacterial infections.

The purpose of the study is to see if taking antibiotics by mouth is as effective as receiving them through a vein for treating infective endocarditis. Participants in the study will receive either the oral antibiotic or the parenteral antibiotic treatment. The study will monitor participants over a period of time to observe any differences in outcomes such as hospitalizations, the need for additional heart surgery, or the recurrence of the infection.

Throughout the study, researchers will also look at the quality of life and satisfaction of the participants, as well as the costs associated with each type of treatment. This will help determine if one method is more beneficial overall. The study aims to provide valuable information on the best way to treat infective endocarditis, potentially improving care for future patients with this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting specific criteria, including being 18 years or older and having a diagnosis of infective endocarditis based on the modified Duke criteria.
Eligibility requires a history of at least 10 days of appropriate intravenous antibiotic treatment, with at least one week following valve surgery if applicable.
Additional requirements include a body temperature below 38.0°C for more than two days, a significant reduction in C-reactive protein levels, and a white blood cell count below 15 × 10(9)/L.
No signs of abscess formation should be present, as confirmed by echocardiography.
Step 2
Randomization and treatment assignment
Participants are randomly assigned to receive either oral or parenteral antibiotic treatment.
The oral treatment involves taking amoxicillin in tablet form, administered orally.
The dosage for the oral treatment is 1000 mg of amoxicillin, taken as prescribed by the study protocol.
Step 3
Treatment phase
The treatment phase involves regular administration of the assigned antibiotic therapy.
Participants receiving oral treatment will take amoxicillin tablets as directed.
The duration of the treatment phase is determined by the study protocol and the participant's response to the therapy.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the participant's health status and response to treatment.
Follow-up includes evaluating the occurrence of any unplanned hospitalizations, mortality, cardiac surgery, or relapse of infective endocarditis within six months from diagnosis.
Additional assessments may include quality of life evaluations and monitoring for complications related to antibiotic administration.
Step 5
Completion of the study
The study concludes with a final assessment of the participant's health and treatment outcomes.
Data collected throughout the study is analyzed to determine the effectiveness and safety of the oral antibiotic treatment compared to the parenteral approach.

Who can join the trial?

7 criteria

The patient must have **infective endocarditis** on the left side of the heart. This can be either on a natural heart valve or an artificial one. The infection should be caused by specific bacteria that are not resistant to treatment.
The patient must be **18 years old or older**.
The patient must have received at least **10 days of appropriate intravenous antibiotic treatment**. If the patient had heart valve surgery, they must have had at least one week of this treatment after the surgery.
The patient's body temperature must be **below 38.0°C** for more than two days.
The patient's **C-reactive protein** (a marker of inflammation) must have decreased to less than 25% of its highest value or be below 20 mg/L. Additionally, the **white blood cell count** must be less than 15 billion per liter during antibiotic treatment.
No signs of an **abscess** (a collection of pus) should be found in the heart using an **echocardiogram** (a heart ultrasound).
An **echocardiogram** should be performed, preferably within 48 hours of being chosen for the study. This can be a standard echocardiogram or a portable one, as long as it is recorded in the patient's medical history.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with **infective endocarditis**. This is an infection of the inner lining of the heart chambers and valves.
Patients who are not within the specified age range for the study.
Patients who do not belong to the specified clinical trial group.
Patients who are not part of the vulnerable population selected for the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
Consorci Sanitari De Terrassa
Verified
Terrassa, Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain

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Investigated drugs

Oral Antibiotic Therapy
is a treatment where patients take antibiotics by mouth to fight infections. In this trial, the goal is to see if taking antibiotics orally is as effective as receiving them through an injection for treating infective endocarditis, which is an infection of the heart's inner lining.
Parenteral Antibiotic Treatment (OPAT)
involves administering antibiotics through an injection, usually into a vein. This method is often used for serious infections that require high doses of antibiotics directly into the bloodstream. The trial aims to compare this traditional method with oral antibiotic therapy to determine if both are equally effective for treating infective endocarditis.

Amoxicillin

What is already known about the treatment

Amoxicillin
Amoxicillin is typically administered orally in the form of tablets or capsules. It is widely recognized in medical literature as an effective antibiotic for treating various bacterial infections. The main therapeutic indication for amoxicillin is the treatment of infections caused by susceptible bacteria, including infective endocarditis. At the molecular level, amoxicillin works by inhibiting the synthesis of bacterial cell walls, leading to the destruction of the bacteria. It is classified pharmacologically as a penicillin-type antibiotic.
Ceftriaxone
Ceftriaxone is usually administered through injection, either intravenously or intramuscularly. It is well-documented in medical literature as a broad-spectrum antibiotic used to treat serious bacterial infections. The primary therapeutic indication for ceftriaxone includes severe infections such as infective endocarditis. Its mechanism of action involves inhibiting bacterial cell wall synthesis, which results in bacterial cell death. Ceftriaxone belongs to the pharmacological class of cephalosporin antibiotics.

Investigated diseases

Infective Endocarditis – This is an infection of the inner lining of the heart chambers and valves, typically caused by bacteria entering the bloodstream and attaching to damaged areas of the heart. The disease often begins with symptoms like fever, chills, and fatigue. As it progresses, it can lead to more severe symptoms such as heart murmurs, shortness of breath, and swelling in the legs or abdomen. Over time, the infection can cause damage to the heart valves, leading to complications like heart failure. The condition may also result in small blood clots or pieces of infected tissue breaking off and traveling to other parts of the body, causing further issues. Early detection and management are crucial to prevent significant heart damage.