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Study on the Effectiveness and Safety of 7 vs. 14 Days of Antibiotic Treatment with Meropenem for Patients with Pseudomonas Aeruginosa Blood Infection

Fast replyRegistered 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 treatment of Pseudomonas aeruginosa bacteremia, a type of blood infection caused by the bacteria Pseudomonas aeruginosa. The study aims to determine if a shorter, 7-day course of antibiotics is more effective and safer compared to the traditional 14-day course. The antibiotics being studied include Meropenem, Aztreonam, Levofloxacin, Amikacin, Colistimethate Sodium, Ciprofloxacin, Ceftazidime, Tobramycin, Imipenem, Cilastatin, Piperacillin, Tazobactam, Cefiderocol, Avibactam, Vaborbactam, and Delafloxacin. Some of these medications are given as injections or infusions, while others are taken orally as tablets.

The purpose of the study is to evaluate whether the shorter treatment can effectively treat the infection while reducing the risk of serious side effects and minimizing the exposure to antibiotics. Participants in the study will be randomly assigned to receive either the 7-day or 14-day antibiotic treatment. The study will monitor the participants' health and recovery over a period of time, checking for any recurrence of the infection, side effects, or other health issues.

Throughout the study, the effectiveness of the treatment will be assessed using a method called the DOOR/RADAR analysis, which helps in ranking the outcomes based on their desirability. The study will also track the number of days participants need antibiotics and their overall health status at the end of the follow-up period. This research aims to provide valuable insights into optimizing antibiotic use for treating Pseudomonas aeruginosa bacteremia, potentially leading to improved treatment guidelines in the future.

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

    Joining the study

    Upon joining the study, the patient must have signed the informed consent form.

    The patient must be an adult, 18 years or older, and have bacteremia caused by Pseudomonas aeruginosa.

    The patient should have received 6 days (+/-1) of active antibiotic treatment against the bacteremia before randomization.

  2. Step 2

    Randomization

    The patient will be randomly assigned to one of two groups: a 7-day antibiotic treatment group or a 14-day antibiotic treatment group.

    This step determines the duration of the antibiotic treatment the patient will receive.

  3. Step 3

    Antibiotic treatment

    The patient will receive antibiotics for either 7 or 14 days, depending on the group assigned during randomization.

    The antibiotics used may include meropenem, aztreonam, levofloxacin, amikacin, colistimethate sodium, ciprofloxacin, ceftazidime, tobramycin, cefiderocol, ceftazidime, avibactam, piperacillin, tazobactam, cilastatin sodium, imipenem monohydrate, delafloxacin, meropenem, vaborbactam, cefepime, tazobactam, ceftolozane.

    The administration route for these antibiotics can be intravenous or oral, depending on the specific medication.

  4. Step 4

    Follow-up

    The primary endpoint will be assessed 30 days after the end of the antibiotic treatment, focusing on the days of antibiotic treatment and the DOOR scale category.

    Secondary endpoints include all-cause mortality, clinical cure, treatment failure, superinfections, serious adverse events, days of hospital stay, and recurrences, assessed at 30 and 90 days after the end of the treatment.

Who can join the trial?

4 criteria

  • Adult patients who are **18 years or older**.
  • Currently have **bacteremia** due to **P. aeruginosa**. Bacteremia means there are bacteria in the blood, and **P. aeruginosa** is a type of bacteria.
  • Have received **6 days** (plus or minus 1 day) of active antibiotic treatment for the bacteremia. This is counted from the date when the first positive blood test was taken until the time of randomization in the study.
  • Have signed the **informed consent** for the trial. This means they have agreed to participate after being informed about the study details.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of infection that is not caused by P. aeruginosa. This is a specific type of bacteria.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a known allergy to the antibiotics being used in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a severe medical condition that might interfere with the study. This could be a condition that affects the heart, liver, or kidneys.
  • Patients who have a weakened immune system, which means their body has a harder time fighting infections.
  • Patients who are unable to follow the study procedures or instructions.
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Investigated drugs

Antibiotic Treatment This clinical trial is investigating the use of antibiotics to treat infections caused by the bacteria Pseudomonas aeruginosa in the bloodstream. The study is comparing two different durations of antibiotic treatment: one group will receive antibiotics for 7 days, while the other group will receive antibiotics for 14 days. The goal is to determine if the shorter treatment duration is as effective as the longer one, while also reducing the risk of serious side effects and overall exposure to antibiotics.

What is already known about the treatment

Piperacillin/Tazobactam – This medication is administered intravenously, typically through an IV drip. It is currently well-established in medical practice and literature as a treatment for various bacterial infections. The main therapeutic indication for Piperacillin/Tazobactam is the treatment of bacteremia caused by Pseudomonas aeruginosa. At the molecular level, Piperacillin works by inhibiting bacterial cell wall synthesis, while Tazobactam inhibits beta-lactamase enzymes, enhancing Piperacillin's effectiveness. It is classified as a combination antibiotic, specifically a penicillin-class antibacterial with a beta-lactamase inhibitor.

Investigated diseases

Pseudomonas aeruginosa bacteremia – This condition occurs when the bacterium Pseudomonas aeruginosa enters the bloodstream, leading to an infection. It often starts in another part of the body, such as the lungs or urinary tract, and spreads to the blood. The disease can cause symptoms like fever, chills, and low blood pressure. As it progresses, it may lead to more severe complications if not managed properly. The infection is known for being resistant to many antibiotics, making it challenging to treat. It is commonly seen in individuals with weakened immune systems or those in hospital settings.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508441-41-00Protocol codeSHORTEN-IIEstimated enrolment306 patientsSponsorFundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla

sourced from the EU Clinical Trials Register and site verification

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