Study on Continuous vs. Intermittent Infusion of Ampicillin and Ceftriaxone for Patients with Enterococcus faecalis Infective Endocarditis

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What is this study about?

This clinical trial is focused on studying the treatment of Enterococcus faecalis infective endocarditis, a serious infection of the heart’s inner lining caused by the bacteria Enterococcus faecalis. The study will compare two methods of administering antibiotics: continuous infusion and intermittent infusion. The antibiotics being tested are ampicillin and ceftriaxone. Ampicillin is a type of penicillin antibiotic, while ceftriaxone is a cephalosporin antibiotic. Both are commonly used to treat bacterial infections.

The purpose of the study is to determine if continuous infusion of these antibiotics is as effective as intermittent infusion in treating the infection. Participants in the study will receive either the continuous or intermittent infusion of the antibiotics. The study will monitor the frequency of disease recurrence, which means checking if the infection comes back after treatment. The study will also look at other factors, such as the need for changes in antibiotic treatment, unplanned surgeries, and any side effects related to the medication.

The study will last for a period of up to 42 days of treatment, with follow-up assessments to check for any recurrence of the infection or other health issues. Participants will be monitored for up to one year after completing the antibiotic treatment to ensure the infection does not return and to assess overall health outcomes. The study aims to provide valuable information on the best way to administer these antibiotics for treating Enterococcus faecalis infective endocarditis.

1 joining the study

Upon joining the study, eligibility is confirmed based on age (18 years or older) and a diagnosis of infective endocarditis caused by Enterococcus faecalis.

Informed consent is required to participate in the study.

2 treatment initiation

The treatment involves the administration of two antibiotics: ampicillin and ceftriaxone.

These medications are given through an intravenous route, which means they are delivered directly into the bloodstream.

3 treatment administration

The study compares two methods of administering the antibiotics: continuous infusion and intermittent infusion.

Continuous infusion involves a steady and constant delivery of medication, while intermittent infusion involves administering the medication at intervals.

4 monitoring and follow-up

Throughout the study, the effectiveness of the treatment is monitored by checking for any recurrence of the infection.

The primary goal is to ensure that the continuous infusion method is not less effective than the intermittent method.

5 evaluation of outcomes

The study evaluates several outcomes, including treatment failure, mortality, and any need for changes in antibiotic treatment.

Other factors assessed include unplanned surgeries, readmissions, and any adverse effects related to the medication.

6 completion of treatment

The treatment period lasts for six weeks, after which the patient’s health is monitored for up to one year to check for any recurrence of the infection.

The study aims to gather data on the long-term effectiveness and safety of the treatment methods.

Who Can Join the Study?

  • Adult patients who are 18 years of age or older.
  • Patients with a possible or definitive diagnosis of infective endocarditis due to Enterococcus faecalis. This diagnosis should be made according to the Duke-ISCVID criteria, which are guidelines used by doctors to identify this type of heart infection.
  • Patients must have signed informed consent, meaning they agree to participate in the study after being informed about what it involves.

Who Cannot Join the Study?

  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who have medical conditions or factors that the study has not specifically mentioned as being included.
  • Patients who are unable to follow the study procedures or take the study medications as required.
  • Patients who have other health issues that could interfere with the study or make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Hospital Universitario Virgen Macarena Sevilla Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario De Cruces Barakaldo Spain
Hospital Universitario Araba Vitoria Spain
Hospital Universitario De Canarias La Laguna Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
Hcdkhbhx Spt Ppyul Logrono Spain
Hjfvzicc Uslzkcizmcbbi Mgwdkog De Vwpgzwcgyr Santander Spain
Hxwffvqo Uxntmoxwxqffu Rnedubky Da Mpasal Malaga Spain
Huabthzv Uaxhjhqgafiew Mazdi Tuhcdqwt Terrassa Spain
Hmexknwg Ubgecaxytvfpi Dhvwarlj Donostia / San Sebastian Spain
Fndcgntxg Pihf Lf Izryezawgcdif Blrhcabbr Dom Hapzxjar Ueuaidkeredcu Lx Pxo Madrid Spain
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
02.09.2024

Trial locations

Ampicillin is an antibiotic used to treat a variety of bacterial infections. In this clinical trial, it is being tested to see if it can effectively treat Enterococcus faecalis infective endocarditis when given continuously, as opposed to intermittently. The goal is to determine if continuous infusion is as effective as the traditional method of administering the medication.

Ceftriaxone is another antibiotic that is often used in combination with other antibiotics to treat serious infections. In this study, it is paired with ampicillin to evaluate its effectiveness in treating Enterococcus faecalis infective endocarditis. The trial is comparing the outcomes of continuous infusion versus intermittent infusion to see if there is a difference in the recurrence of the disease.

Investigated diseases:

Enterococcus faecalis infectious endocarditis – This disease is an infection of the inner lining of the heart chambers and valves, caused by the bacterium Enterococcus faecalis. It typically occurs when bacteria enter the bloodstream and attach to damaged areas of the heart. The infection can lead to inflammation and damage to the heart valves, potentially causing them to malfunction. Symptoms may include fever, fatigue, heart murmurs, and signs of heart failure. The disease progresses as the bacteria continue to grow and form clumps, which can break off and travel to other parts of the body, causing further complications. If not managed, it can lead to severe heart damage and other systemic issues.

Trial ID:
2024-511719-40-00
Protocol code:
DOβLEI
Trial Phase:
Therapeutic confirmatory (Phase III)

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