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

3 1 1 1

What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Consorci Sanitari De Terrassa	Terrassa	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario De Cruces	Barakaldo	Spain
Hospital Universitario De Canarias	La Laguna	Spain
Hzzkftrl Udwdulimwnypx Majnxgl Dd Vsoklnrhni	Santander	Spain
Hlekpjeb Uvugyvdrmyzwg Dfqhltbs	Donostia / San Sebastian	Spain
Frovmudff Pqcq Ls Iyhboqvtwmkvz Bkxdijnrt Dcp Hnregcfo Uqqztkdancioq Ln Pju	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	31.01.2022

Trial locations

Investigated drugs:

Amoxicillin

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.

Investigated diseases:

Endocarditis bacterial

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.

Trial ID:

2024-519969-21-00

Protocol code:

OraPAT-IE GAMES

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?