Study on the Effects of Oseltamivir and Drug Combination for Patients with Pneumonia

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What is this study about?

This clinical trial is focused on studying treatments for pneumonia, a condition where the lungs become inflamed, often due to an infection. The study will explore the effects of several medications, including Tamiflu (oseltamivir), Hydrocortisone, Prednisolone, and Dexamethasone. These medications are being tested to see how they might help patients recover from pneumonia, especially when it is caused by viruses like influenza.

The purpose of the study is to provide reliable estimates of how these treatments affect the chances of survival and the time it takes for patients to be discharged from the hospital. Participants in the study will receive one of the medications or a placebo, and their progress will be monitored over a period of time. The study aims to understand which treatments are most effective in helping patients recover from pneumonia.

During the study, patients will be given the medication in different forms, such as capsules, tablets, or injections, depending on the specific treatment. The study will last for a maximum of 10 days for each participant, and their health will be closely observed to gather information on the effectiveness of the treatments. The results will help doctors make better decisions about how to treat pneumonia in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as being hospitalized, aged 18 or older, and having a pneumonia syndrome.

The study focuses on patients with specific diagnoses, including confirmed influenza A or B infection or community-acquired pneumonia.

2 treatment allocation

Participants are randomly assigned to receive one of the study treatments.

The treatments include oseltamivir (Tamiflu 75 mg hard capsules) taken orally, hydrocortisone (100 mg powder for solution) administered via IV infusion, prednisolone (10 mg tablets) taken orally, dexamethasone (3.3 mg/ml solution) administered via injection, and dexamethasone (2.0 mg tablets) taken orally.

3 treatment administration

The medications are administered according to the assigned treatment group.

The frequency and duration of administration depend on the specific treatment protocol for each medication.

4 monitoring and assessment

Participants are monitored for their response to the treatment, including any side effects or changes in their condition.

The primary focus is on the effect of the treatments on mortality and the time to discharge from the hospital.

5 end of study participation

The study aims to assess outcomes such as 28-day all-cause mortality and time to discharge alive from the hospital.

Participation in the study concludes after the specified observation period, which may last up to 28 days.

Who Can Join the Study?

  • Patients must be hospitalized and 18 years or older.
  • Must have a pneumonia syndrome, which means a clinical diagnosis based on:
    • Typical symptoms of a new respiratory infection.
    • Objective evidence of acute lung disease, such as hypoxia (low oxygen levels in the blood), compatible imaging, or clinical examination.
    • Other possible causes are considered unlikely.
  • Must have one of the following diagnoses:
    • Confirmed influenza A or B infection.
    • Community-acquired pneumonia with planned antibiotic treatment, without suspected or confirmed SARS-CoV-2, influenza, active pulmonary tuberculosis, or Pneumocystis pneumonia.
  • No medical history that might, in the opinion of the patient’s doctor, put the patient at significant risk if they were to participate in the trial.
  • No reason that the trial treatment definitely should, or should not, be given, in the opinion of the patient’s doctor. This only affects eligibility for the relevant comparison.

Who Cannot Join the Study?

  • Patients who are not diagnosed with pneumonia cannot participate. Pneumonia is an infection that inflames the air sacs in one or both lungs.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate. This group includes individuals with certain characteristics needed for the study.
  • Patients who are not able to give informed consent or understand the study requirements cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France
Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy
ASST Fatebenefratelli Sacco Milan Italy
Region Oestergoetland Linkoping Sweden
Universitair Ziekenhuis Gent Gent Belgium
Hospital Edouard Herriot Lyon France
Hospital Del Mar Barcelona Spain
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Amphia Hospital Breda The Netherlands
Pellegrin Hospital Bordeaux France
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
University Of Strasbourg STRASBOURG, Alsace France
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu Balotesti Romania
Hospital Universitario Central De Asturias Oviedo Spain
Soedersjukhuset AB Stockholm Sweden
Hospital of Infectious Diseases and Pneumology Victor Babes, Timisoara Timisoara Romania
Hospital Universitario Virgen Macarena Sevilla Spain
Sihtasutus Parnu Haigla Paernu Estonia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Universita’ Degli Studi Di Verona Verona Italy
Tartu University Hospital Tartu Estonia
Hospital Da Luz S.A. Lisbon Portugal
Karolinska University Hospital Solna Sweden
Universita’ Di Pisa Pisa Italy
Universita’ Politecnica Delle Marche Ancona Italy
San Raffaele Scientific Institute Milan Italy
Jessa Ziekenhuis Hasselt Belgium
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
Laane-Tallinna Keskhaigla AS Pohja-Tallinna Linnaosa Estonia
Sankt Gorans Sjukhus Stockholm Sweden
Centre Hospitalier Universitaire De Nice Nice France
Institutul National De Boli Infectioase Prof.Dr.Matei Bals Bucharest Romania
Spitalul Clinic De Boli Infectioase Constanta Constanta Romania
Azienda Provinciale Per I Servizi Sanitari Trento Italy
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Emergency Institute For Cardiovascular Diseases And Transplant Targu Mures Romania
North Estonia Medical Centre Foundation Tallin Estonia
Spitalul Clinic De Boli Infectioase Sf. Parascheva Iasi Iasi Romania
Cysxlvqca Ufcerjpbjewjcn Suudtxmyh Woluwe-Saint-Lambert Belgium
Fbjaxxts Dcr Vwcxdv Bsuuc Bucharest Romania
Hkppoopt Db Lfj Aayopeje Sgqx Vila Nova De Gaia Portugal
Cjqwsj Hbkiaprloth Rvteovud Dmpykwwbvhmvng Angers France
Cvhzbveb Hzjzurmosvvg Urmmblrswevhp Dy Vrmm Vigo Spain
Htsbwht Bbtrze Cctcjezuhwdpig Arclu Paris France
Lkttnjxnoued Kboepy Kalmar Sweden
Ufflfrfnbr ok Gdvscuvqup ayc Shazizoqeil Uqdqemodhe Hgorlodt (hpi Gothenburg Sweden
Rzjytfqkuygmvuyp Hdbqifwg Garches France
Ndhlmmtwl unkslieebkptmcefbjn Umea Sweden
Cpslqe Henhhqewdcr Ey Uqvwycldlzaon Dm Lxhpcrb Limoges France
Crqgmh Huqxugbpgst Rfinadyo Ubteoaxsqzetr Dv Tpzwm Tours France
Aawehnaep Upm Amsterdam The Netherlands
Hbxrahvi Dz Lp Scucu Ckcz I Sxzk Ply Barcelona Spain
Hycmzxhs Utkoqdgoliqmi Hioavugf Tkypt y Pqcjio Iqrxkont Cmlsrq dntstzbxlkeomwubj (ikwi Badalona Spain
Hlojnzvc Vuni dogrktir Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.12.2023
Estonia Estonia
Recruiting
01.12.2023
France France
Recruiting
01.12.2023
Italy Italy
Recruiting
01.12.2023
Portugal Portugal
Recruiting
01.12.2023
Romania Romania
Recruiting
01.12.2023
Spain Spain
Recruiting
01.12.2023
Sweden Sweden
Recruiting
01.12.2023
The Netherlands The Netherlands
Recruiting
01.12.2023

Trial locations

Dexamethasone is a medication used in this trial to help reduce inflammation in the body. It is a type of steroid that can help improve breathing and reduce the severity of symptoms in patients with severe respiratory issues, such as those caused by COVID-19.

Tocilizumab is an immunosuppressive drug that is used to treat severe inflammation. In the context of this trial, it is being tested to see if it can help reduce the immune system’s overreaction in patients with severe COVID-19, potentially improving their outcomes.

Baricitinib is a medication that works by interfering with the activity of certain enzymes in the body that are involved in inflammation. It is being studied in this trial to determine if it can help reduce the severity of COVID-19 symptoms by modulating the immune response.

Regeneron is a combination of monoclonal antibodies designed to target the coronavirus. This therapy aims to help the immune system fight off the virus more effectively, potentially reducing the severity and duration of the illness in patients with COVID-19.

Convalescent Plasma is a therapy that involves using blood plasma from people who have recovered from COVID-19. The plasma contains antibodies that may help patients currently fighting the virus by boosting their immune response.

Investigated diseases:

Pneumonia – Pneumonia is an infection that inflames the air sacs in one or both lungs, which may fill with fluid or pus. This condition can cause symptoms such as cough, fever, chills, and difficulty breathing. It can be caused by a variety of organisms, including bacteria, viruses, and fungi. The disease can range from mild to severe, depending on factors like the type of germ causing the infection and the individual’s age and overall health. As the infection progresses, it can lead to complications such as pleurisy, lung abscesses, or acute respiratory distress syndrome. Recovery time can vary, with some individuals experiencing prolonged fatigue and weakness even after the infection has cleared.

Trial ID:
2023-507441-29-00
NCT ID:
NCT04381936
Trial Phase:
Therapeutic confirmatory (Phase III)

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