Study on Dexamethasone and Sodium Chloride for Treating Severe Hospital-Acquired Pneumonia in Critically Ill Patients with a Proinflammatory Profile

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What is this study about?

This clinical trial is focused on studying the treatment of hospital-acquired pneumonia, a type of lung infection that patients can get while staying in the hospital. The study is investigating the use of a medication called dexamethasone phosphate, which is given as a solution through an injection or infusion into the veins. This medication is being tested to see if it can help treat severe cases of hospital-acquired pneumonia in patients who have a strong inflammatory response, which means their bodies are reacting with a lot of inflammation.

The purpose of the study is to find out how effective dexamethasone phosphate is when used alongside the usual care that patients receive, compared to a placebo, which is a substance with no active medication. The study will involve patients receiving either the medication or the placebo, and their progress will be monitored over a period of time. The treatment with the medication or placebo will last for up to five days, and the patients’ health will be checked regularly to see how they are responding to the treatment.

Throughout the study, researchers will look at various outcomes, such as whether the pneumonia is cured and the overall survival of the patients after 28 days. They will also monitor for any side effects or complications that might occur during the treatment period. The study aims to provide valuable information on whether dexamethasone phosphate can be a beneficial addition to the standard care for patients with severe hospital-acquired pneumonia.

1 joining the study

Upon joining the study, participation is confirmed through informed consent from a legal representative or an emergency procedure, if necessary. Consent from the patient is obtained as soon as possible if they are unable to provide it initially.

2 initial assessment

An initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of hospital-acquired pneumonia and ensuring the patient meets the inclusion criteria, such as age and specific health conditions.

3 randomization

Participants are randomly assigned to receive either dexamethasone plus standard care or a placebo plus standard care. This process is double-blind, meaning neither the patient nor the healthcare providers know which treatment is being administered.

4 treatment administration

The treatment involves the administration of dexamethasone phosphate and sodium chloride through intravenous use. The specific dosage and frequency are determined by the healthcare team based on the study protocol.

5 monitoring and follow-up

Regular monitoring is conducted to assess the patient’s response to treatment. This includes daily evaluations of body temperature, heart rate, oxygen levels, and other vital signs. Blood tests are performed every 48 hours for 10 days to monitor leukocyte counts.

The patient’s progress is evaluated at specific intervals, including a test-of-cure visit and assessments at Day 28, Month 3, and Month 6.

6 end of study participation

Participation in the study concludes after the final assessment at Month 6. The study aims to determine the effectiveness of the treatment in achieving a clinical cure and reducing mortality rates.

Who Can Join the Study?

  • Adults aged between 18 and 85 years old.
  • Diagnosed with hospital-acquired pneumonia. This is a lung infection that occurs 48 hours or more after being admitted to the hospital. The diagnosis is based on certain signs like high body temperature, changes in white blood cell count, and lung changes seen on a chest X-ray.
  • Severe condition defined by a specific measure of lung function called PaO2/FiO2 ratio being less than 200 while on a breathing machine.
  • Showing signs of a strong body reaction to infection, with a CRP (a blood test that shows inflammation) level of 150 mg/L or higher.
  • Currently receiving treatment with antibiotics for the pneumonia for less than 48 hours.
  • Consent given by a legal representative or through an emergency procedure if the patient cannot consent themselves. If the patient is unable to consent at the start, their consent will be obtained as soon as possible.
  • Covered by a health insurance plan.
  • Women who can have children must agree to use effective birth control methods for the first 28 days of the study. This can include not having sex, using condoms with spermicide, contraceptive sponges, diaphragms, hormonal birth control, or intrauterine devices.

Who Cannot Join the Study?

  • Patients who do not have severe hospital-acquired pneumonia cannot participate. This is a type of lung infection that occurs in people who are in the hospital.
  • Patients who do not have a pro-inflammatory profile are excluded. This means their body is not showing signs of inflammation, which is the body’s response to infection or injury.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups are excluded. This means the study is looking for specific types of patients.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or the elderly.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Kat Attica General Hospital Kifissia Greece
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
CHU Gabriel-Montpied Clermont Ferrand France
Hopital Beaujon Clichy France
Hospital Del Mar Barcelona Spain
General Hospital Of Larissa Koutlibaneio And Triantafylleio Larissa Greece
Evangelismos S.A. Athens Greece
General University Hospital Of Larissa Larissa Greece
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Clinique Saint-Pierre Ottignies (CSPO) Ottignies Belgium
Gukjpf Hdtaljmgrgh Udktgelgoggdk Pdmdr Pmdtkrwtvjl Ee Ntumairqarem Paris France
Rdjmgwhclxhbtsrj Hmpuddyd Garches France
Csobjuckq Urqioaueevdqun Sxgigxrvk Woluwe-Saint-Lambert Belgium
Lmkng Ghfedqq Hnyewcja Oq Atrpgn Athens Greece
Clscfw Hxeafnreofu Eu Uedcbgvrrpthu Dp Lrtqmbt Limoges France
Ayphshyqxm Paaxestc Hfvsydfs Dj Myfrummad Marseille France
Uwa Mnxihzwjolud Yvoir Belgium
Cjhm Df Nepee Vandoeuvre Les Nancy France
Csvvrl Hybllyvvoyx Rxdqgtbl Dmlmgkhftwpmeu Angers France
Hwbxuoiz Vlfy dwjnkqeo Barcelona Spain
Himjyvcs Ulmqndsfwvysrf Sofhfgubpg &gkydjw Hmxcsvh dh Hxnrfdzvsqc STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.02.2024
France France
Recruiting
01.02.2024
Greece Greece
Recruiting
01.02.2024
Spain Spain
Recruiting
01.02.2024

Trial locations

Dexamethasone is a medication used in this trial to treat severe hospital-acquired pneumonia in critically ill patients. It is a type of steroid that helps reduce inflammation in the body. In this study, it is being tested to see if it can improve outcomes for patients with a pro-inflammatory profile when added to the standard care they are already receiving.

Hospital-acquired pneumonia – This is a type of lung infection that occurs in patients during their stay in a hospital, typically 48 hours or more after admission. It is not present at the time of admission and is often caused by bacteria that are resistant to antibiotics. The disease progresses as bacteria invade the lungs, leading to inflammation and fluid accumulation in the air sacs. Patients may experience symptoms such as cough, fever, chills, and difficulty breathing. The condition can worsen if not managed properly, potentially leading to complications like respiratory failure. Hospital-acquired pneumonia is a significant concern due to its association with prolonged hospital stays and increased healthcare costs.

Trial ID:
2023-508153-12-00
Protocol code:
RC23_0358
NCT ID:
NCT06269900
Trial Phase:
Therapeutic confirmatory (Phase III)

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