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Study on the Effectiveness of Co-Trimoxazole for Treating Ventilator-Associated Pneumonia in ICU Patients Compared to a Drug Combination

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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 a treatment for Ventilator-Associated Pneumonia (VAP), a type of lung infection that occurs in people who are on mechanical ventilation in an intensive care unit. The study is investigating the use of a medication called Co-trimoxazole as a treatment option. Co-trimoxazole is a combination of two antibiotics, sulfamethoxazole and trimethoprim, which work together to fight bacterial infections.

The purpose of the study is to determine if Co-trimoxazole is as effective as the best standard treatments currently available for treating VAP. Participants in the study will receive either Co-trimoxazole or another standard treatment, which may include medications like Temocillin, Piperacillin Sodium, Ciprofloxacin, Levofloxacin, Cefotaxime, Ofloxacin, Piperacillin, Ceftriaxone, Imipenem Monohydrate, Amoxicillin Sodium, Aztreonam, Ertapenem, Meropenem, or Cefepime. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatments.

The study will last for a period of up to six weeks, during which participants will be closely monitored. The main focus will be on the participants' health status 28 days after starting the treatment. Additional observations will include the number of days participants are free from mechanical ventilation, the length of stay in the ICU and hospital, and any side effects or allergic reactions to the medications. The study aims to provide valuable information on the safety and effectiveness of Co-trimoxazole as a treatment for VAP in intensive care settings.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose and procedures. You will be asked to provide consent to participate.

    Eligibility criteria include being an adult aged 18 or older, having been on mechanical ventilation for at least five days, and having a confirmed diagnosis of ventilator-associated pneumonia (VAP).

  2. Step 2

    Initial treatment

    You will receive an initial treatment with an appropriate antibiotic therapy for 24 to 72 hours. This treatment is based on the bacteria causing the infection and their susceptibility to antibiotics.

  3. Step 3

    Randomization

    After the initial treatment, you will be randomly assigned to receive either cotrimoxazole or the best standard of care as a de-escalation treatment. This means that the treatment will be adjusted to a less intensive therapy.

  4. Step 4

    Treatment administration

    The medication will be administered through an intravenous infusion. This involves delivering the medication directly into your bloodstream through a vein.

    The duration and frequency of the treatment will be determined by the medical team based on your specific condition and response to the treatment.

  5. Step 5

    Monitoring and assessments

    Throughout the trial, your health will be closely monitored. This includes checking your vital signs, conducting laboratory tests, and performing imaging studies to assess your response to the treatment.

    Your progress will be evaluated at various points, including 7 to 10 days after the VAP diagnosis and at day 28.

  6. Step 6

    Follow-up

    Your vital status will be assessed at day 28 and day 90. This involves checking your overall health and any changes in your condition.

    Additional assessments may include the number of days you are free from mechanical ventilation, the length of your stay in the intensive care unit and hospital, and any new episodes of VAP.

Who can join the trial?

6 criteria

  • Must be an adult (18 years or older).
  • Must have been on a breathing machine (mechanical ventilation) for at least five days.
  • Must have a confirmed diagnosis of ventilator-associated pneumonia (VAP) through a test, preferably from a sample taken deep in the lungs. If not possible, a sample from the windpipe is acceptable.
  • The infection must be caused by bacteria called Enterobacteriaceae that can be treated with the study medication, cotrimoxazole. If there are multiple types of bacteria, all must be treatable with the study medication.
  • Must have been treated with at least one effective antibiotic for 24 to 72 hours before joining the study. If there are multiple types of bacteria, all must be treatable with the initial antibiotics.
  • Must have stable or improving blood pressure and breathing conditions. This means either the same or a reduced need for medications that support blood pressure and either the same or improved oxygen levels in the blood.

Who cannot join the trial?

5 criteria

  • Patients who are not in the Intensive Care Unit (ICU). The ICU is a special area in the hospital where very sick patients receive close monitoring and care.
  • Patients who do not have Ventilator-associated Pneumonia (VAP). This is a type of lung infection that can occur in people who are on a ventilator, a machine that helps them breathe.
  • Patients who are not within the specified age range for the study. The study may have specific age requirements.
  • Patients who are not part of the specified clinical trial groups. The study may be looking for participants with certain characteristics or conditions.
  • Patients who are not considered part of a vulnerable population. Vulnerable populations may include groups like children, pregnant women, or those with certain health conditions.
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Investigated drugs

Cotrimoxazole is a combination of two antibiotics, sulfamethoxazole and trimethoprim, that work together to treat bacterial infections. In this clinical trial, it is being tested to see if it is as effective as the best standard treatments currently used for treating Ventilator-Associated Pneumonia (VAP) in patients in intensive care units. The goal is to determine if cotrimoxazole can be a reliable option for treating this type of pneumonia, which occurs in patients who are on mechanical ventilation.

What is already known about the treatment

Cotrimoxazole – Cotrimoxazole is administered orally or intravenously, depending on the patient's condition and the severity of the infection. It is currently being studied in clinical trials for its effectiveness in treating ventilator-associated pneumonia (VAP) in intensive care units. The main therapeutic use of cotrimoxazole is to treat bacterial infections, particularly those affecting the respiratory system. At the molecular level, cotrimoxazole works by inhibiting the production of folic acid in bacteria, which is essential for their growth and reproduction. It is classified as an antibiotic, specifically a combination of sulfamethoxazole and trimethoprim, which work together to enhance its antibacterial effects.

Investigated diseases

Ventilator-associated Pneumonia – Ventilator-associated Pneumonia is a lung infection that occurs in people who are on mechanical ventilation breathing machines in hospitals. It typically develops 48 hours or more after mechanical ventilation is initiated. The disease is characterized by inflammation of the lung tissue due to bacterial infection. Patients may experience symptoms such as fever, increased white blood cell count, and purulent sputum. The progression involves the accumulation of fluid and pus in the alveoli, leading to impaired gas exchange. If not managed, it can lead to further complications, including respiratory distress.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505108-52-00Protocol codeAPHP220799Estimated enrolment628 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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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.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).