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
Hospital Da Luz S.A. Lisbon Portugal
Karolinska University Hospital Solna Sweden
Centre Hospitalier Universitaire De Nice Nice France
Hospital Del Mar Barcelona Spain
Amphia Hospital Breda The Netherlands
University Of Strasbourg STRASBOURG, Alsace France
San Raffaele Scientific Institute Milan Italy
Cxjxjksti Uuaomdawybxujd Szewgahoi Woluwe-Saint-Lambert Belgium
Hjqyoyms Vvxm dyrsiauy Barcelona Spain
Njpzy Erugvpd Myjowzx Ctjsgg Fnslseegfk Tallin Estonia
Fgyymqlakm Ilggh Cc Gvujdi Oqicttyx Msujpksk Pdagvfguzqs Milan Italy
Ratfgs Sbukg Sykeqe Ukrrisirrbuesvlyzce Lund Sweden
Ujuajatqawyfnlghd Diczm Svfff Ds Vogoch Verona Italy
Cruuih Hwscshhgxcr Rfrhpjwt Ubzrybhrskvtk Dq Tetlw Tours France
Ulpuhflybuqqmaruu Ppepljdzenl Dhkbf Mwzhod Ancona Italy
Jcjjb Zoemjihlpm Hasselt Belgium
Arcwssa Oxklwyitxvy Ugpnhsflsjqkv Fbskomzx Iw Du Ndysuj Naples Italy
Ssity Gvfuav Sxkkpnh Stockholm Sweden
Hvvkxusc Dm Lt Sussm Coqj I Sxwx Pvb Barcelona Spain
Umybviqidzty Zsfbbkhbva Gept Gent Belgium
Pwbzzmpkg Hkjpnaoo Bordeaux France
Cuyube Hramihqhucm Rsndrhuz Djtvdtnoclifhj Angers France
Hksptuly Cgcloop Umxsfrgkuacas Loycyv Bzdll Zaragoza Spain
Cghj Ckmtsk Cwovhkd Asbdmkjye Bifph Akaxrwehgk Braga Portugal
Czxmhxmx Hqkbyinmnbim Umzubyivmmgvo Dn Vhch Vigo Spain
Adwqali Oolhgqbijti Unamoujflwxol Pninga Pisa Italy
Fwlrklxt Ddx Vbthvs Bsfgy Bucharest Romania
Hdoszpi Ssyjn Acvqslj Paris France
Acefwmw Smdghhxto Uuktgahrglajm Gwiwtxda Iszzqzbb Trieste Italy
Hbdtqnbx ol Idequlsjmj Dtecfwlv ajr Pnqdxdamay Vpxsea Bmgdnx Tszojrxow Timisoara Romania
Hhmoiav Blbwhh Ccaxxkjvrwlopq Afict Paris France
Sytqdebcpf Pfkrj Hsjjxm Paernu Estonia
Udfkteytor oi Gaorupmrnw aaz Syjfvhcngax Urwgeiusha Hpynvirn (nfj Gothenburg Sweden
Lqzgerlvaaav Kvqpke Kalmar Sweden
Öcchup Ukwhletiqa Hmhjrzcu Orebro Sweden
Sltpdjyo Cedaoj Ds Bxxa Iludzigbskj Squ Pnqijcelqg Iitm Iasi Romania
Nwqdqcuck ubmblteupzpqtikdked Umea Sweden
Cxmfck Hfiokwsbhyy Ep Uwqjghcwhpovb Dw Lwzegyz Limoges France
Trbqw Utkiubhaow Hccmlscx Tartu Estonia
Addhbszaj Usj Amsterdam The Netherlands
Aruupvz Sfggaconngosmn Tcaomsfqtboj Smaku Pqyvr E Cspxb Milan Italy
Lszmasazbnaygx Kklsisqwin Ac Pohja-Tallinna Linnaosa Estonia
Ikfagkhmre Ngnlglnh Dw Bfnu Itgimpusqgp Pyqbedicjjpdd Bdje Bucharest Romania
Silxesgj Clltet Dg Bmpe Idfqiczmpmt Cuzqibyeh Constanta Romania
Ahds Fezhpmqfxoyyljbp Stimh Milan Italy
Atobons Poojpskmmal Pxw I Shmcalc Scnpsztg Trento Italy
Rtbdkx Oyfdjcjsmaaquo Linkoping Sweden
Hwcacmlg Epftqcz Hbjbcrl Lyon France
Jhemcx Bncvt Zyslezhyif Syuancnwt S-Hertogenbosch The Netherlands
Rhfhvjprctpssean Hvjdorof Garches France
Avsspaj Ovrovkylbsy Ulhwplyysejya Pajqjpmxmyh Pprqy Gdilbtky Palermo Italy
Ujxazdk Lndzm Dv Sjwtg Dx Mulnkqwfvu Eerzhn Senhora Da Hora Portugal
Ejkdfeyop Iahftzjey Ftr Cykemblcvetbnx Dcjwrkrm Alf Tytotjyphw Targu Mures Romania
Sjdfifwh Ciksdv Da Utfxdxg Pozk Ds Alilivd Ijgpiok Balotesti Romania
Hbzxelpl Utuliujfohgzf Hivqremn Tmgqq y Pcxsgz Irdbcwrr Cqdcip dhpggkvwdnyxdxcre (rikd Badalona Spain
Sletvibbkjtewm Stockholm The Netherlands

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.

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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