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Study Comparing 7-Day and 14-Day Treatment with Vancomycin, Linezolid, and Daptomycin for Patients with Uncomplicated Enterococcal Blood Infections

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What is this study about?

This clinical trial is focused on studying the treatment of uncomplicated bacteremia caused by two types of bacteria: Enterococcus faecalis and Enterococcus faecium. Bacteremia is a condition where bacteria are present in the blood, which can lead to infections. The trial aims to compare the safety and effectiveness of a shorter, 7-day antibiotic treatment with a longer, 14-day treatment. The antibiotics being studied include Vancomycin, Linezolid, Piperacillin Sodium combined with Tazobactam Sodium, Clavulanic Acid, Daptomycin, Amoxicillin, and Ampicillin Sodium. These medications are commonly used to treat bacterial infections and will be administered either intravenously (through a vein) or orally (by mouth).

The purpose of this study is to determine if the shorter treatment is as effective as the longer one in treating uncomplicated enterococcal bacteremia. Participants in the study will receive either the 7-day or 14-day treatment and will be monitored for their response to the medication. The study will assess various outcomes, such as the success of the treatment, any side effects, and the overall health of the participants during and after the treatment period.

Participants will be closely observed throughout the study to ensure their safety and to gather information on how well the treatments work. The study will help determine if a shorter course of antibiotics can be just as effective, which could lead to shorter hospital stays and reduced exposure to antibiotics. This research is important for improving treatment strategies for patients with uncomplicated bacteremia caused by Enterococcus bacteria.

1 joining the study

Upon joining the study, the patient is required to provide signed informed consent.

Eligibility is confirmed for adult patients (18 years or older) hospitalized with uncomplicated bacteremia caused by E. faecalis or E. faecium.

2 initial treatment phase

The treatment begins with the administration of antibiotics. The specific medication and route of administration depend on the patient’s condition and the study protocol.

Medications include vancomycin, linezolid, piperacillin with tazobactam, clavulanic acid, daptomycin, ampicillin, and amoxicillin. These are administered either intravenously or orally.

3 monitoring and adjustment

During the first 72 hours, the patient’s fever should disappear, and blood cultures are performed between days 2-3 to ensure negative results.

The treatment duration is either 7 days or 14 days, depending on the study group assignment.

4 completion of treatment

After completing the assigned treatment duration, the patient’s clinical success is evaluated.

The primary goal is to demonstrate that a 7-day treatment is not less effective than a 14-day treatment.

5 follow-up and evaluation

Follow-up visits are conducted to monitor for any relapse or secondary infections.

The patient’s overall health, including survival and any adverse events, is assessed.

Who Can Join the Study?

  • Adult patients who are 18 years or older and are in the hospital with a type of infection in the blood caused by bacteria called E. faecalis or E. faecium.
  • Patients must have a negative result in blood tests done between the second and third day after starting treatment. This means the bacteria should not be found in the blood anymore.
  • Patients should have a fever that goes away within the first 72 hours of starting treatment. A fever is when the body temperature is higher than 37.8°C.
  • Patients need to provide a signed informed consent, which means they agree to participate in the study after being informed about it.

Who Cannot Join the Study?

  • Patients with a different type of infection that is not caused by E. faecalis or E. faecium cannot participate. These are specific types of bacteria.
  • Patients who have a complicated infection, meaning the infection has spread or caused other health issues, are not eligible.
  • Patients who are unable to take antibiotics for any reason cannot join the study.
  • Patients who are currently participating in another clinical trial are not allowed to join this one.
  • Patients with a known allergy to the antibiotics being used in the study cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible to join the study.
  • Patients with severe liver or kidney disease, which affects how the body processes medications, cannot participate.
  • Patients who have a weakened immune system, which makes it harder for the body to fight infections, are not eligible.
  • Patients who have had a recent surgery or are planning to have surgery soon cannot join the study.
  • Patients who are unable to follow the study procedures or attend follow-up visits are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Hospital Universitario De Jaen Jaen Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Hospital Universitario Torrecardenas Almeria Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Universitario De Cruces Barakaldo Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hospital Universitario Virgen De Valme Sevilla Spain
Servei De Salut De Les Illes Balears Palma Spain
Hospital Costa del Sol Marbella Spain
Heczujsq Uwnhligkmegro Dy La Pywrusxq Madrid Spain
Htccpliz Uzwdcfazirrkx Msjhrmb Dg Vwtzmqltyy Santander Spain
Cmcknnnq Hrxcbvbohjny Uhgbgjjtjvifc Dm Vtem Vigo Spain
Hkltzzkn Uvirbvkcimciv Mhqtk Ttsotabb Terrassa Spain
Hodzehbh Ubfkioppqsgog Duwmgtrm Donostia / San Sebastian Spain
Hnlghvgv Dr Lp Ssayt Crjn I Scyf Pqi Barcelona Spain
Hommhgth Ubdzckmztlcmi dh A Cqnqci A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
15.07.2022

Trial locations

Investigated drugs:

Antibiotic Treatment
This medication is used to treat infections caused by bacteria. In this clinical trial, the antibiotic is being tested to see if a shorter 7-day treatment is as effective as the traditional 14-day treatment for uncomplicated enterococcal bacteremia. The goal is to determine if the shorter treatment can provide the same benefits while potentially reducing side effects and improving patient convenience.

Investigated diseases:

Uncomplicated Enterococcal Bacteremia – This condition is characterized by the presence of enterococci bacteria, specifically E. faecalis or E. faecium, in the bloodstream. It is termed “uncomplicated” when it does not involve other serious infections or complications such as infective endocarditis. The bacteria can enter the bloodstream through various routes, often originating from infections in other parts of the body. Once in the bloodstream, the bacteria can cause symptoms like fever, chills, and fatigue. The condition progresses as the bacteria multiply, potentially leading to systemic inflammation. Monitoring and managing the infection is crucial to prevent further complications.

Trial ID:
2023-508456-18-00
Protocol code:
INTENSE
NCT ID:
NCT05394298
Trial Phase:
Therapeutic confirmatory (Phase III)

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