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Study on Preventing Early Respiratory Infections in Intubated Patients Using Ceftriaxone, a Cough Simulator, and Subglottic Secretion Aspiration

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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 preventing early respiratory tract infections in patients who are intubated due to a reduced level of consciousness from severe trauma, brain injury, stroke, cardiac arrest, or other causes. The study will explore the use of a short course of a systemic antibiotic called ceftriaxone, a device known as a Bionic Cough Simulator, and a method for removing secretions from the throat area called subglottic aspiration.

The purpose of the study is to compare the safety and effectiveness of these treatments in preventing infections in critically ill patients who are on a breathing machine. Participants will receive one or more of these treatments, and their health will be monitored for any severe side effects related to the devices, the antibiotic, or infections. The study will last for up to 14 days, during which the occurrence of respiratory infections like pneumonia and tracheobronchitis will be closely observed.

Throughout the study, researchers will also track other health outcomes, such as the duration of intubation, the length of stay in the intensive care unit, and the overall recovery of the patients. The study aims to provide valuable insights into the best ways to prevent infections in patients who require mechanical breathing support.

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 will be informed about the trial's purpose, which is to prevent early respiratory tract infections in patients who are intubated. Intubation is a procedure where a tube is placed into the windpipe to help with breathing.

    The patient will be monitored for any severe adverse events related to the devices used, the antibiotics administered, and any infections that may occur from the start of the trial until day 14.

  2. Step 2

    Medication administration

    The patient will receive a short course of a systemic antibiotic called ceftriaxone. This medication is given as a solution for injection through a vein, known as intravenous administration.

    The dosage and frequency of ceftriaxone will be determined by the medical team based on the patient's condition and needs.

  3. Step 3

    Monitoring and procedures

    Throughout the trial, the patient will undergo procedures such as the use of a cough simulator and aspiration of subglottic secretions. These are methods used to help clear the airways and prevent infections.

    The patient will be closely monitored for any signs of respiratory tract infections, such as pneumonia or tracheobronchitis, from the start of the trial until day 14.

  4. Step 4

    Evaluation of outcomes

    The primary outcomes being evaluated include the incidence of severe adverse events related to the devices, antibiotics, and infections, as well as the occurrence of respiratory tract infections during the first 14 days.

    Secondary outcomes include the duration of intubation, total days of respiratory support, days spent in the intensive care unit, and other health-related measures up to 90 days.

Who can join the trial?

7 criteria

  • Must have a tube placed in the windpipe to help with breathing, and this is expected to last more than 48 hours. This is called endotracheal intubation.
  • Must be older than 17 years.
  • Must have one of the following conditions:
    • Severe trauma or severe head trauma
    • Ischemic stroke (a type of stroke caused by a blockage in blood flow to the brain) or hemorrhagic stroke (a type of stroke caused by bleeding in the brain)
    • Have had a cardiac arrest and have been successfully resuscitated (this is called ROSC, which stands for Return of Spontaneous Circulation)
    • Intoxications of the CNS (Central Nervous System), which means harmful substances affecting the brain and spinal cord
    • Status epilepticus, which is a condition where a person has a long-lasting seizure or multiple seizures without recovering in between

Who cannot join the trial?

5 criteria

  • Patients with a **reduced level of consciousness** due to severe trauma, which means serious physical injury.
  • Patients with **traumatic brain injury**, which is damage to the brain caused by an external force.
  • Patients who have had a **stroke**, which is a medical condition where poor blood flow to the brain results in cell death.
  • Patients who have experienced **cardiac arrest**, which is when the heart suddenly stops beating.
  • Patients with a reduced level of consciousness from other causes not specified.
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Investigated drugs

  • Systemic Antibiotic

    This medication is used to help prevent infections in the lungs of patients who are on a breathing machine. It works by killing or stopping the growth of bacteria that can cause infections. In this trial, the antibiotic is given for a short period to see if it can safely and effectively reduce the risk of lung infections in patients who are critically ill and need help with breathing.

  • Cough Simulator

    This is a device used to help clear mucus and other secretions from the lungs. It simulates the action of coughing, which is a natural way the body clears the airways. By helping to remove these secretions, the cough simulator aims to prevent infections in the lungs of patients who are on a breathing machine.

  • Aspiration of Subglottic Secretions

    This therapy involves removing secretions that build up just above the breathing tube in the throat. These secretions can be a source of infection if they enter the lungs. By regularly removing them, this therapy aims to reduce the risk of lung infections in patients who are critically ill and need a breathing machine.

What is already known about the treatment

Systemic Antibiotic – This medication is administered through the bloodstream, typically via an injection or intravenous drip, to help prevent infections in patients who are critically ill and intubated. It is currently being studied in clinical trials to assess its safety and effectiveness in preventing early respiratory tract infections in these patients. The main therapeutic use is to reduce the risk of infections in patients with reduced consciousness due to severe trauma, brain injury, stroke, or cardiac arrest. At the molecular level, systemic antibiotics work by targeting and killing bacteria or stopping their growth, helping the body's immune system to fight off infections. They are classified as antibacterial agents in pharmacology.

Investigated diseases

Reduced Level of Consciousness – This condition involves a decrease in a person's awareness and responsiveness to their surroundings. It can result from various causes, including severe trauma, traumatic brain injury, stroke, or cardiac arrest. The progression of reduced consciousness can vary, with individuals experiencing anything from slight confusion to complete unresponsiveness. In some cases, the condition may improve over time, while in others, it may persist or worsen. The level of consciousness is often assessed using scales that measure responsiveness to stimuli. The condition requires careful monitoring to understand its progression and potential underlying causes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521454-42-00Protocol codePIRAMIDES (24/096-E)Estimated enrolment60 patientsSponsorHospital Clinico San Carlos

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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