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Study on the Effectiveness of Clarithromycin and Other Drug Combinations for Patients with Uncomplicated Staphylococcus aureus Blood Infection

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 the effectiveness of different durations of antibiotic treatment for a condition known as Staphylococcus aureus bacteremia. This condition occurs when the bacteria Staphylococcus aureus enters the bloodstream, potentially leading to serious infections. The study aims to compare the outcomes of patients receiving either seven or fourteen days of antibiotic treatment to determine which duration is more effective in preventing the return of the infection and ensuring patient survival.

The antibiotics being studied include several well-known medications such as Clarithromycin, Meropenem, Ceftriaxone, Cefotaxime, Piperacillin/Tazobactam, Vancomycin, Dicloxacillin, Flucloxacillin, Linezolid, Clindamycin, Levofloxacin, Moxifloxacin, Amikacin, Gentamicin, Benzylpenicillin, Cloxacillin, and Daptomycin. Some patients will receive a placebo, which is a substance with no active medication, to help compare the effects of the antibiotics. The purpose of the study is to find out if a shorter treatment period is just as effective as a longer one, which could help reduce side effects and healthcare costs.

Participants in the study will be randomly assigned to receive either seven or fourteen days of treatment. They will be monitored for 90 days after the start of the treatment to check for any signs of the infection returning or any other health issues. The study will also look at the overall health and survival of the participants during this period. This research is important for improving the treatment of Staphylococcus aureus bacteremia and ensuring patients receive the most effective care.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, participants are randomly assigned to one of two groups. One group will receive 7 days of antibiotic treatment, while the other group will receive 14 days of treatment.

    The purpose of this randomization is to compare the effectiveness of the two different treatment durations.

  2. Step 2

    Treatment administration

    Participants will receive antibiotics that are effective against Staphylococcus aureus. The specific medication and route of administration will depend on the participant's condition and the study protocol.

    Medications may include options such as clarithromycin (oral), meropenem (intravenous), and others as specified in the study protocol.

  3. Step 3

    Monitoring and follow-up

    Participants will be monitored for any signs of clinical or microbiological failure during the treatment period and up to 90 days after diagnosis.

    Regular follow-up appointments will be scheduled to assess the participant's health status and to collect necessary data for the study.

  4. Step 4

    Evaluation of outcomes

    The primary outcome is the 90-day survival without clinical or microbiological failure or relapse.

    Secondary outcomes include all-cause mortality at various time points, microbiological failure, clinical failure, and any severe adverse events.

Who can join the trial?

5 criteria

  • Must be **18 years or older**.
  • Must have a **blood test** that shows the presence of **Staphylococcus aureus**, a type of bacteria.
  • Must have started **antibiotic treatment** that works against **Staphylococcus aureus** within **12 hours** of the first positive blood test.
  • Must have a **body temperature** of less than **37.8°C (100°F)** at the time of being chosen for the study.
  • Must have a **follow-up blood test** that shows no **Staphylococcus aureus** between **48 to 120 hours** after the initial diagnosis of the infection.

Who cannot join the trial?

2 criteria

  • Patients with a different type of infection other than Staphylococcus aureus bacteremia cannot participate. Staphylococcus aureus bacteremia is a condition where a specific type of bacteria, called Staphylococcus aureus, is present in the blood.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible.
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Investigated drugs

Antibiotics are used in this clinical trial to treat uncomplicated Staphylococcus aureus bacteremia. The study aims to compare the effectiveness of a 7-day course versus a 14-day course of antibiotic treatment. Antibiotics help to kill or stop the growth of bacteria causing the infection, and the trial is investigating whether a shorter treatment duration is as effective as a longer one in preventing mortality and recurrence of the infection.

What is already known about the treatment

Antibiotic Treatment for Staphylococcus aureus Bacteremia – This medication is administered orally or intravenously, depending on the specific antibiotic used and the severity of the infection. It is currently being studied in clinical trials to determine the optimal duration of treatment for uncomplicated Staphylococcus aureus bacteremia. The main therapeutic indication is to treat infections caused by Staphylococcus aureus bacteria. The mechanism of action involves inhibiting bacterial cell wall synthesis or protein synthesis, depending on the specific antibiotic, leading to the death of the bacteria. It is classified pharmacologically as an antibiotic, which is a type of antimicrobial agent used to treat bacterial infections.

Investigated diseases

Staphylococcus aureus bacteremia – This disease is an infection where the bacteria Staphylococcus aureus enter the bloodstream. It can occur when bacteria from a skin infection or other source spread into the blood. The condition can lead to symptoms such as fever, chills, and low blood pressure. As the infection progresses, it may affect various organs, potentially leading to complications like endocarditis or osteomyelitis. The disease requires careful monitoring to prevent further spread and complications. It is important to manage the infection promptly to avoid severe outcomes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519186-21-01Estimated enrolment284 patientsSponsorHvidovre Hospital

sourced from the EU Clinical Trials Register and site verification

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