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Study on Acyclovir for Patients with Herpes Simplex Virus Reactivation in the Throat on Mechanical Ventilation with One or No Organ Failure

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What is this study about?

This clinical trial is focused on patients who are in the Intensive Care Unit (ICU) and are receiving help to breathe through a machine, known as mechanical ventilation. These patients have a reactivation of the Herpes simplex virus (HSV) in their throat and have one or no organ failures. The study is investigating the use of a medication called acyclovir, which is a powder that is mixed into a solution for injection, to see if it can help reduce the risk of death in these patients. The trial will compare the effects of acyclovir with a placebo to determine its effectiveness.

The purpose of the study is to find out if treating these patients with acyclovir can lower the chances of dying within 60 days. Participants in the study will receive either acyclovir or a placebo through an intravenous (IV) injection, which means the medication is given directly into a vein. The treatment will last for up to 14 days. During the study, doctors will monitor the patients’ health, including how long they need mechanical ventilation, their stay in the ICU, and any changes in their condition.

Throughout the study, various health indicators will be checked, such as the presence of HSV in the throat and any signs of lung infections or other complications. The study aims to provide valuable information on whether acyclovir can be a beneficial treatment for patients with HSV reactivation in the ICU, potentially improving their chances of recovery and reducing the length of their hospital stay.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, mechanical ventilation duration, and HSV throat reactivation.

Consent is required from the patient or a designated representative.

2 randomization

Participants are randomly assigned to receive either the treatment with aciclovir or a placebo.

This process ensures that the study results are unbiased.

3 treatment administration

The treatment involves the administration of aciclovir through intravenous infusion.

The dosage is 500 mg, prepared as a powder for solution for injection.

The frequency and duration of administration are determined by the study protocol.

4 monitoring and assessments

Regular assessments are conducted to monitor health status, including the SOFA score and other health indicators.

These assessments occur at specified intervals: days 1, 3, 5, 7, 10, 14, 21, and 28 post-randomization.

5 evaluation of outcomes

The primary outcome is the mortality rate at day 60 post-randomization.

Secondary outcomes include day-90 mortality, duration of mechanical ventilation, and incidence of HSV-related conditions.

6 completion of study participation

Participation concludes after the final assessments and evaluations are completed.

The study aims to determine the effectiveness of aciclovir in reducing mortality and improving health outcomes.

Who Can Join the Study?

  • Must be 18 years old or older.
  • Must be on invasive mechanical ventilation for at least 96 hours and expected to continue for at least 48 more hours. This means a machine is helping you breathe.
  • Must have HSV reactivation in the throat. This is confirmed by a test called PCR that checks for the presence of the herpes virus in a throat swab.
  • Must have 1 or no organ failures. Organ failure is when an organ is not working properly, and it is measured by a score called SOFA. A score of 3 or 4 indicates organ failure.
  • Must have written consent from you, a close relative, or a trusted person you have previously appointed. In emergencies, there might be a different procedure for consent.
  • Must be covered by social security.

Who Cannot Join the Study?

  • Patients who are not in the Intensive Care Unit (ICU).
  • Patients who are not on invasive mechanical ventilation. This means they are not using a machine to help them breathe through a tube.
  • Patients who do not have HSV throat reactivation. This refers to the reactivation of the herpes simplex virus in the throat.
  • Patients with more than one organ failure. Organ failure means that an organ, like the heart or kidneys, is not working properly.
  • Patients who are younger than 18 years old or older than 65 years old.
  • Patients who are not male or female.
  • Patients who are not considered part of a vulnerable population. This means they are not in a group that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Hopital Beaujon Clichy France
Aeyrmgzsga Plshabdq Hgtjrrip Dz Mqueklwij Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
08.01.2024

Trial locations

Investigated drugs:

Acyclovir is a medication used in this trial to treat patients who are intubated and mechanically ventilated. It is specifically aimed at those who have a reactivation of the Herpes simplex virus in the throat and have one or fewer organ failures. The goal of using acyclovir in this trial is to reduce the mortality rate of these patients by day 60.

Investigated diseases:

Herpes Simplex Virus Throat Reactivation – This condition occurs when the herpes simplex virus, which typically causes cold sores, becomes active again in the throat. It is often seen in patients who are critically ill and require mechanical ventilation in an intensive care unit (ICU). The virus can cause inflammation and discomfort in the throat, potentially complicating the patient’s recovery. Reactivation is more likely when the immune system is weakened, such as during severe illness or stress. The condition can lead to further complications if not managed properly, but it primarily affects the throat area.

Trial ID:
2023-505510-26-00
Protocol code:
APHP220800
Trial Phase:
Therapeutic confirmatory (Phase III)

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