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Study on the Effects of Amikacin Sulfate and Protective Isolation in Critically Ill Neutropenic Patients with Sepsis

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 effects of a treatment for patients who are critically ill and have a condition called sepsis. Sepsis is a serious illness that occurs when the body has an extreme response to an infection, which can lead to tissue damage, organ failure, and even death. The study involves patients who are in intensive care and have a weakened immune system, a condition known as neutropenia. Neutropenia means having a very low number of a type of white blood cell called neutrophils, which are important for fighting infections. This condition can be caused by cancer or its treatment.

The treatment being studied includes the use of a medication called amikacin sulfate, which is an antibiotic that belongs to a group of drugs known as aminoglycosides. Antibiotics are medicines used to treat infections caused by bacteria. In this study, amikacin sulfate is given to patients through a vein, a method known as intravenous use. The purpose of the study is to see if adding amikacin sulfate to the usual antibiotic treatment can improve the outcomes for these patients. Additionally, the study is looking at whether not using protective isolation, a practice where patients are kept separate to prevent infections, affects the patients' recovery.

The study will follow patients for a period of time to observe their health outcomes, including survival rates and any side effects they may experience. Researchers will also monitor the occurrence of kidney problems, hearing loss, and other serious health events. The goal is to understand if the combination of treatments can help reduce the risk of death and improve recovery in patients with sepsis and neutropenia. The study is expected to continue until 2025, and the findings will help guide future treatments for critically ill patients with these conditions.

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, eligibility is confirmed based on criteria such as age (18 years or older), admission to an intensive care unit, and specific medical conditions like sepsis or septic shock.

    Consent is obtained, either informed or deferred, to participate in the trial.

  2. Step 2

    Initial treatment phase

    The initial treatment involves the administration of amikacin sulfate, an antibiotic given through an intravenous route.

    The dosage and frequency are determined by the medical team based on individual needs and the study protocol.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, regular monitoring is conducted to assess the impact of the treatment on health outcomes.

    Key assessments include the evaluation of mortality rates at day 28 and day 90, kidney function, hearing, and the occurrence of any serious adverse events.

  4. Step 4

    Completion of the trial

    The trial is expected to conclude by August 16, 2025.

    Final assessments are made to determine the overall effectiveness and safety of the treatment strategies.

Who can join the trial?

6 criteria

  • Must be **18 years or older**.
  • Must be admitted to one of the participating **Intensive Care Units (ICU)**.
  • Must have **sepsis** or **septic shock**. These are serious conditions where the body has a severe response to an infection.
  • Must have an **underlying tumor**, have undergone **allogeneic stem cell transplantation**, or have a **blood-related cancer** (hematological malignancy).
  • Must have **neutropenia**, which means having a very low number of a type of white blood cell called neutrophils. This is defined as having less than 500 neutrophils per cubic millimeter of blood or less than 1000 white blood cells per cubic millimeter, related to a cancer or its treatment.
  • Must provide **informed consent** or have consent given on their behalf if they are unable to do so.

Who cannot join the trial?

7 criteria

  • Patients who are not adults. This means anyone under 18 years old cannot participate.
  • Patients who are not admitted to the intensive care unit. This is a special hospital area for very sick patients who need close monitoring.
  • Patients who are not able to give their own consent to participate. This means they must be able to understand the study and agree to join it.
  • Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
  • Patients who have a known allergy to aminoglycosides. Aminoglycosides are a type of antibiotic, and an allergy means their body reacts badly to it.
  • Patients who are already participating in another clinical trial. This is to avoid any interference between different studies.
  • Patients with a condition that the study doctors believe would make it unsafe for them to participate. This is to protect the patient's health.
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Investigated drugs

  • Aminoglycosides

    are a group of antibiotics used in this trial to see if adding them to the initial antibiotic treatment can improve outcomes for critically ill patients with sepsis. These antibiotics work by stopping bacteria from making proteins, which are essential for their growth and survival. The trial aims to determine if this combination can reduce mortality rates in patients with weakened immune systems.

  • Protective Isolation

    is a strategy used to prevent infections in patients with weakened immune systems by limiting their exposure to germs. In this trial, the effectiveness of not using protective isolation is being compared to the standard practice to see if it impacts patient outcomes. The goal is to find out if avoiding routine protective isolation can be as safe and effective as using it.

What is already known about the treatment

Aminoglycosides – Aminoglycosides are a class of antibiotics typically administered intravenously or intramuscularly. They are currently used in medical practice, particularly in treating severe infections in critically ill patients, such as those in intensive care units. The main therapeutic indication for aminoglycosides is the treatment of serious bacterial infections, including sepsis. At the molecular level, aminoglycosides work by binding to bacterial ribosomes, inhibiting protein synthesis, which ultimately leads to bacterial cell death. They are classified as antibacterial agents and are often used in combination with other antibiotics to enhance their effectiveness.

Investigated diseases

  • Acute Kidney Injury (AKI)

    This condition occurs when the kidneys suddenly become unable to filter waste products from the blood. It can develop rapidly over a few hours or days and is often seen in patients who are critically ill or in intensive care. The accumulation of waste products can lead to an imbalance of fluids and electrolytes in the body. Symptoms may include decreased urine output, swelling due to fluid retention, and fatigue. AKI can be caused by factors such as reduced blood flow to the kidneys, direct damage to the kidneys, or blockage of the urinary tract. Recovery can vary, with some patients experiencing full recovery while others may have lasting kidney damage.

  • Hearing Loss

    This condition involves a partial or total inability to hear sounds in one or both ears. It can occur suddenly or gradually and may be temporary or permanent. Causes include exposure to loud noise, infections, aging, and certain medications that can damage the inner ear. Symptoms often include difficulty understanding speech, especially in noisy environments, and frequently asking others to speak more slowly or loudly. Hearing loss can affect communication and quality of life, leading to social isolation or frustration. It is important to identify the underlying cause to manage the condition effectively.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514042-36-00Protocol codeAPHP180690Estimated enrolment340 patientsSponsorAssistance Publique Hopitaux De Paris

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