Could a plasma protein cut deaths in severe pneumonia?

NCT ID NCT05722938

Disease control Sponsor: Biotest Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 4 times

Summary

This phase 3 trial tests whether adding trimodulin (a protein mixture from donated blood) to standard care can lower death rates in adults with severe community-acquired pneumonia who need a breathing machine. About 590 hospitalized patients will receive either trimodulin or a placebo for five days. The main goal is to see if fewer people die within 28 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: trimodulin (a protein mixture from human blood plasma)
What this could lead to: If it works, this could provide a new add-on treatment to reduce deaths in severe pneumonia patients on ventilators.
What could go wrong: This is a late-stage trial, but previous similar therapies have failed. The benefit may be small or limited to certain patients, and there are risks from the infusion itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 590 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main Inclusion Criteria: 1. Written informed consent. 2. Hospitalized, adult (≥ 18 years of age) subject; In US only: ≥ 12 years of age 3. Signs of inflammation based on C-reactive protein threshold level. 4. Diagnosis of active community-acquired pneumonia (CAP) before hospital-admission or within 48 hours after admission. 5. Radiological (or other imaging technology) evidence consistent with active pneumonia. 6. Acute respiratory failure requiring IMV. Main Exclusion Criteria: 1. For an incapacitated subject: any indication that the subject's presumed will would be against inclusion in the trial. 2. Pregnant or lactating women. 3. Subjects of childbearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment. 4. Subjects on ECMO at start of IMP treatment. 5. Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP). 6. Subjects discharged from hospital within the previous 14 days. 7. Defined neutrophil counts up to one calendar day prior to start of IMP treatment. 8. Defined platelet counts up to one calendar day prior to start of IMP treatment. 9. Defined hemoglobin within up to one calendar day prior to start of IMP treatment. 10. Pre-existing hemolytic disease. 11. Thromboembolic events (TEEs) caused by other reasons than the current sCAP within 3 months before start of IMP treatment unless the risk for further TEEs can be adequately managed with standard prophylaxis or treatment. 12. Severe renal impairment prior to start of IMP treatment. 13. End-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS). 14. Pre-existing severe lung diseases concomitant to current sCAP (e.g. active tuberculosis, active lung cancer). 15. Pre-existing decompensated heart failure. 16. Pre-existing severe hepatic cirrhosis (Child Pugh score ≥ 10 points), or severe hepatic impairment (Child Pugh score ≥ 10 points), or hepatocellular carcinoma. 17. Known intolerance to proteins of human origin or known allergic reactions to components of trimodulin / placebo. 18. Selective immunoglobulin A (IgA) deficiency with known antibodies to IgA. 19. Life expectancy of less than 90 days, according to the investigator's clinical judgment, because of medical conditions related neither to sCAP nor to sCAP-associated septic conditions. 20. Morbid obesity with high body mass index (BMI) ≥ 40 kg/m2, or malnutrition with low BMI \< 16 kg/m2. 21. Treatment with polyvalent immunoglobulin preparations during the last 21 days before start of IMP treatment. 22. Known treatment with predefined medications, during the last 2 days before start of IMP treatment. 23. Hematopoietic stem cell transplantation or previous lung transplantation. 24. Treatment with investigational medications/procedures not according to SoC of the trial site, due to participation in another interventional clinical trial within 30 days before start of IMP treatment, or previous treatment with IMP in this clinical trial.

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Conditions

The condition(s) this trial relates to.

Community-Acquired Pneumonia pneumonia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Community-acquired pneumonia

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

89 sites in 15 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

# 1001 St. Michael's Medical Center
WITHDRAWN

Newark, New Jersey, 07102, United States
# 1002 Augusta University
WITHDRAWN

Augusta, Georgia, 30912, United States
# 1003 William Beaumont Hospital
WITHDRAWN

Royal Oak, Michigan, 48073, United States
# 1004 Ohio State University Wexner Medical Center
ACTIVE_NOT_RECRUITING

Columbus, Ohio, 43210, United States
# 1005 Mercury Street Medical Group
WITHDRAWN

Butte, Montana, 59701, United States
# 1006 Hannibal Clinic
WITHDRAWN

Hannibal, Missouri, 63401, United States
# 1010 Sparrow Clinical Research Institute Site 1010
WITHDRAWN

Lansing, Michigan, 48912, United States
# 1011 Buffalo VA Medical Center
WITHDRAWN

Buffalo, New York, 14215, United States
# 1013 University of Oklahoma Health Sciences Center
WITHDRAWN

Oklahoma City, Oklahoma, 73104, United States
# 1015 UC Davis Health
WITHDRAWN

Sacramento, California, 95817, United States
# 1016 Jefferson University Hospitals
WITHDRAWN

Philadelphia, Pennsylvania, 19107, United States
# 1017 Wake Forest Baptist
RECRUITING

Winston-Salem, North Carolina, 27157, United States
# 1018 Vanderbilt University Medical Cente
WITHDRAWN

Nashville, Tennessee, 37232, United States
# 1019 University of Utah
WITHDRAWN

Salt Lake City, Utah, 84108, United States
# 1020 Medical City Fort Worth
WITHDRAWN

Fort Worth, Texas, 76104, United States
# 1021 Northern Westchester Hospital
RECRUITING

Mount Kisco, New York, 10549, United States
# 1022 Houston Methodist Hospital
RECRUITING

Houston, Texas, 77030, United States
# 1022 Houston Methodist Hospital
NOT_YET_RECRUITING

Houston, Texas, 77030, United States
# 1023 Mount Sinai Hospital
NOT_YET_RECRUITING

New York, New York, 10029, United States
# 1025 University of Cincinnati College of Medicine
NOT_YET_RECRUITING

Cincinnati, Ohio, 45267, United States
# 1026 Intermountain Medical Center
NOT_YET_RECRUITING

Murray, Utah, 84107, United States
# 1028 University of Maryland, Baltimore
NOT_YET_RECRUITING

Baltimore, Maryland, 21201, United States
# 1030 NYU Langone Medical Center (Tisch Hospital)
NOT_YET_RECRUITING

New York, New York, 10016, United States
# 1031 Health Hospitals Bellvue
NOT_YET_RECRUITING

New York, New York, 10016, United States
# 1032 NYC Langone Brooklyn
NOT_YET_RECRUITING

New York, New York, 11220, United States
# 1033 Banner University Medical Center
NOT_YET_RECRUITING

Phoenix, Arizona, 85006, United States
# 1034 Brigham and Women's Hospital
NOT_YET_RECRUITING

Boston, Massachusetts, 02115, United States
# 2701 Dr JM Engelbrecht Trial Site
WITHDRAWN

Somerset West, Western Cape, 7130, South Africa
# 2703 Worthwhile Clinical Trials
WITHDRAWN

Johannesburg, 1500, South Africa
# 2704 RYEXO Clinical Research Zuid Afrikaans Hospital
WITHDRAWN

Pretoria, 0002, South Africa
# 2705 RYEXO Clinical Research
TERMINATED

Pretoria, 0184, South Africa
# 2706 Johese Clinical Research
WITHDRAWN

Centurion, Gauteng, 0157, South Africa
# 2707 Emmed Clinical Research
WITHDRAWN

Pretoria, Gauteng, 0002, South Africa
# 2708 Into Research
WITHDRAWN

Pretoria, Gauteng, 0181, South Africa
# 3201 Clinique Saint-Pierre
RECRUITING

Ottignies, 1340, Belgium
# 3203 Cliniques Universitaires Saint-Luc
RECRUITING

Brussels, 1200, Belgium
# 3204 Universitair Ziekenhuis Brussel
RECRUITING

Jette, 1090, Belgium
# 3205 HUB Erasme
RECRUITING

Brussels, 1070, Belgium
# 3206 Antwerp University Hospital (UZA)
RECRUITING

Edegem, 2650, Belgium
# 3207 AZ Sint-Jan
RECRUITING

Bruges, 8000, Belgium
# 3208 CHU Charleroi Hôpital Civil Marie Curie
RECRUITING

Lodelinsart, 6042, Belgium
# 3209 C. H. R. de la Citadelle
RECRUITING

Liège, 4000, Belgium
# 3210 AZ Maria Middelares
RECRUITING

Ghent, 9000, Belgium
# 3211 Zol
RECRUITING

Genk, 3600, Belgium
# 3212 Onze Lieve Vrouw Ziekenhuis
NOT_YET_RECRUITING

Aalst, 9300, Belgium
# 3213 AZ Delta VZW
RECRUITING

Roeselare, 8800, Belgium
# 3301 Hôpital Bichat - Claude Bernard
RECRUITING

Paris, 75018, France
# 3302 Hôpital Nord Franche-Comté
WITHDRAWN

Trévenans, Territoire De Belfort, 90400, France
# 3303 Centre Hospitalier de Melun
RECRUITING

Melun, Seine Maritime, 77000, France
# 3304 Hôpital Tenon
TERMINATED

Paris, 75020, France
# 3305 CHU Saint-Etienne
RECRUITING

Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France
# 3306 CHU Strasbourg - Nouvel Hôpital Civil
RECRUITING

Strasbourg, Bas Rhin, 67091, France
# 3308 CHU Strasbourg - Hôpital Hautepierre
WITHDRAWN

Strasbourg, Bas Rhin, 67098, France
# 3309 Centre Hospitalier Victor Dupouy
WITHDRAWN

Argenteuil, Val d'Oise, 95107, France
# 3310 Hôpital Louis Mourier
WITHDRAWN

Colombes, Haute de Seine, 92700, France
# 3311 CHU de Limoges - Hôpital Dupuytren
WITHDRAWN

Limoges, Haute Vienne, 87000, France
# 3312 Hôpital Cochin
RECRUITING

Paris, 75014, France
# 3313 Hôpital Sainte Musse
WITHDRAWN

Toulon, Var, 83056, France
# 3314 CHU Tours - Hôpital Bretonneau
WITHDRAWN

Tours, Indre Et Loire, 37000, France
# 3315 CHRU Lille - Hôpital Salengro
WITHDRAWN

Lille, Landes, 59037, France
# 3316 Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon
WITHDRAWN

Paris, 75020, France
# 3317 CHU Nice-Hopital de l' Archet
RECRUITING

Nice, Alpes Maritime, 06202, France
# 3318 CHU de Grenoble - Hôpital Albert Michallon
RECRUITING

Grenoble, Isere, 38043, France
# 3319 CHU Rennes - Hôpital Pontchaillou
WITHDRAWN

Rennes, Ille Et Vilaine, 35000, France
# 3320 CHU Nice Hopital Pasteur 2
WITHDRAWN

Nice, Alpes Maritime, 6100, France
# 3321 CHU Reims - Hôpital Robert Debré
RECRUITING

Reims, Ardennes, 51100, France
# 3404 Hospital Universitari de Tarragona Joan XXIII
RECRUITING

Tarragona, 43007, Spain
# 3405 Hospital Universitario Reina Sofia
RECRUITING

Córdoba, Cordoba, 14004, Spain
# 3406 Hospital de la Santa Creu i de Sant Pau
RECRUITING

Barcelona, 08041, Spain
# 3407 Hospital Universitari Vall d'Hebrón
RECRUITING

Barcelona, 8035, Spain
# 3408 Hospital Clinic de Barcelona
RECRUITING

Barcelona, 08036, Spain
# 3409 Hospital Universitario Son Espases
RECRUITING

Palma de Mallorca, Balearic Islands, 07120, Spain
# 3410 Hospital Universitario Puerta de Hierro Majadahonda
WITHDRAWN

Majadahonda, Madrid, 28222, Spain
# 3411 Hospital Universitari de Girona Dr Josep Trueta
RECRUITING

Girona, 17007, Spain
# 3413 Hospital Universitario Clinico San Carlos
WITHDRAWN

Madrid, 28040, Spain
# 3414 Hospital del Mar
WITHDRAWN

Barcelona, 08003, Spain
# 3415 Hospital Universitario La Paz
WITHDRAWN

Madrid, 28046, Spain
# 3416 Hospital Universitari i Politecnic La Fe
WITHDRAWN

Valencia, 46026, Spain
# 3417 Hospital Universitari de Bellvitge
RECRUITING

Barcelona, 8907, Spain
# 3418 Clinica Universidad de Navarra
RECRUITING

Pamplona, Navarre, 31008, Spain
# 3419 Hospital Universitari Mutua de Terrassa
RECRUITING

Terrassa, Barcelona, 8221, Spain
# 3420 Hospital Universitario Central de Asturias
NOT_YET_RECRUITING

Oviedo, Principality of Asturias, 33011, Spain
# 3421 Hospital Clinic de Barcelona
NOT_YET_RECRUITING

Barcelona, 08036, Spain
# 3422 Hospital Universitario Virgen del Rocio
RECRUITING

Seville, 41013, Spain
# 3423 Hospital Universitari Parc Tauli
RECRUITING

Sabadell, Barcelona, 08208, Spain
# 3501 St James's Hospital
RECRUITING

Dublin, D08NYH1, Ireland
# 3502 University Hospital Galway
RECRUITING

Galway, H91YR71, Ireland
# 3503 Beaumont Hospital
RECRUITING

Dublin, D09 V2N0, Ireland
# 3504 St Vincents University Hospital
NOT_YET_RECRUITING

Dublin, Dublin 4, Ireland
# 3604 Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
WITHDRAWN

Székesfehérvár, 8000, Hungary
# 3606 Bugat Pal Korhaz
WITHDRAWN

Gyöngyös, 3200, Hungary
# 3607 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
WITHDRAWN

Gyula, 5700, Hungary
# 3608 Pest Megyei Flor Ferenc Korhaz
WITHDRAWN

Kistarcsa, 2143, Hungary
# 3610 Aneszteziologiai es Intenziv Terapias Intezet
WITHDRAWN

Pécs, 7624, Hungary
# 3612 Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
WITHDRAWN

Szeged, 6725, Hungary
# 4001 Institutul Clinic Fundeni
WITHDRAWN

Bucharest, 022328, Romania
# 4002 Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"
WITHDRAWN

Timișoara, 300723, Romania
# 4003 Spitalul Universitar de Urgenta Bucuresti
RECRUITING

Bucharest, 050098, Romania
# 4203 Oblastni nemocnice Kolin a.s.
RECRUITING

Kolín, 28002, Czechia
# 4204 Hospital Kyjov
RECRUITING

Kyjov, 69701, Czechia
# 4301 AKH - Medizinische Universität Wien
WITHDRAWN

Vienna, 1090, Austria
# 4302 KABEG-Klinikum Klagenfurt
WITHDRAWN

Klagenfurt, 9020, Austria
# 4401 St Thomas' Hospital
RECRUITING

London, Greater London, SE1 7EH, United Kingdom
# 4403 Queen Elizabeth University Campus
WITHDRAWN

Glasgow, Strathclyde, G11 6NT, United Kingdom
# 4404 Royal Surrey County Hospital
WITHDRAWN

Guildford, Surrey, GU2 7XX, United Kingdom
# 4405 Derriford Hospital
RECRUITING

Plymouth, Devon, PL6 8DH, United Kingdom
# 4410 King's College Hospital
NOT_YET_RECRUITING

London, Greater London, SE5 9RS, United Kingdom
# 4411 University Hospital of Wales
NOT_YET_RECRUITING

Cardiff, CF14 4XW, United Kingdom
# 4903 Medizinische Hochschule Hannover
WITHDRAWN

Hanover, Lower Saxony, 30625, Germany
# 4904 Charité Universitätsmedizin Berlin - Campus Charité Mitte
WITHDRAWN

Berlin, 10117, Germany
# 4905 Universitätsklinikum Hamburg-Eppendorf
WITHDRAWN

Hamburg, 20246, Germany
# 4909 Universitaetsklinikum Freiburg
WITHDRAWN

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
# 4910 Universitaetsklinikum Essen
RECRUITING

Essen, North Rhine-Westphalia, 45147, Germany
# 5404 Sanatorio de la Trinidad Mitre
WITHDRAWN

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., C1039AAO, Argentina
# 5405 Sanatorio Parque S.A. Privado
WITHDRAWN

San Vicente, Córdoba Province, 5006, Argentina
# 5406 Hospital Italiano de Buenos Aires
WITHDRAWN

Buenos Aires, C1181ACH, Argentina
# 5407 Clinica Adventista Belgrano
WITHDRAWN

Buenos Aires, C1430EGF, Argentina
# 5408 Hospital General de Agudos Dr. Ignacio Pirovano
WITHDRAWN

Buenos Aires, C1430BKC, Argentina
# 5409 Hospital San Roque
WITHDRAWN

Córdoba, Córdoba Province, 5000, Argentina
# 5411 Centro Medico IPAM
WITHDRAWN

Rosario, Santa Fe Province, CP2000, Argentina
# 5412 Clinica Chutro
WITHDRAWN

Córdoba, Córdoba Province, 5000, Argentina
# 5413 Estudios Clinicos de los Arroyos
RECRUITING

San Nicolás, Buenos, 2900, Argentina
# 5414 Cemic
RECRUITING

Buenos Aires, 1431, Argentina
# 5415 Sanatorio de la Canada
RECRUITING

Villa María, Córdoba Province, 5000, Argentina
# 5416 Sanatorio Privado de la Canada - Cordoba
WITHDRAWN

Córdoba, Córdoba Province, X5000BSQ, Argentina
# 5417 Hospital Britanico de Buenos Aires
RECRUITING

Buenos Aires, C1280AEB, Argentina
# 5418 Sanatorio Guemes Site 5418
RECRUITING

Buenos Aires, C1188AAX, Argentina
# 5419 Hospital General de Agudos Dr. J. M. Ramos Mejia
RECRUITING

Buenos Aires, C1221ADC, Argentina
# 5420 Sanatorio Parque S.A.
RECRUITING

Rosario, Santa Fe Province, 2000, Argentina
# 5503 Irmandade da Santa Casa de Misericórdia de Porto Alegre
RECRUITING

Porto Alegre, Rio Grande, 90020-090, Brazil
# 5507 Hospital de Clínicas de Porto Alegre
WITHDRAWN

Porto Alegre, Rio Grande, 90035-903, Brazil
# 5508 HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
WITHDRAWN

Campinas, São Paulo, 13060-904, Brazil
# 5509 Hospital Ernesto Dornelles
WITHDRAWN

Porto Alegre, Rio Grande, 90160-093, Brazil
# 5510 Universidade de Caxias do Sul, IPCEM - Instituto de Pesquisa Clínica para Estudos Multicêntricos
WITHDRAWN

Caxias do Sul, Rio Grande, 95070-560, Brazil
# 5512 UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
RECRUITING

Botucatu, São Paulo, 18618-686, Brazil
# 5513 Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
RECRUITING

São José do Rio Preto, São Paulo, 15090-000, Brazil
# 5514 Universidade Municipal de Sao Caetano do Sul (USCS)
WITHDRAWN

São Caetano do Sul, São Paulo, 09530-700, Brazil
# 5516 Hospital do Rocio
RECRUITING

Campo Largo, Paraná, 83606-177, Brazil
# 5517 Hospital Alemão Oswaldo Cruz
WITHDRAWN

São Paulo, São Paulo, 01323-020, Brazil
# 5518 Hospital de Clínicas de Passo Fundo
RECRUITING

Passo Fundo, Rio Grande, 99010-260, Brazil
# 5519 Hospital Moinhos de Vento
RECRUITING

Porto Alegre, Rio Grande, 90560-032, Brazil
# 6101 Austin Health
RECRUITING

Heidelberg, Victoria, 3084, Australia
# 6102 Princess Alexandra Hospital
WITHDRAWN

Woolloongabba, Queensland, 4102, Australia
# 6103 Sunshine Hospital
RECRUITING

Saint Albans, Victoria, 3021, Australia
# 6104 Footscray Hospital
RECRUITING

Footscray, Victoria, 3011, Australia
# 6105 Monash Medical Centre
RECRUITING

Clayton, Victoria, 3168, Australia
# 6106 Sir Charles Gairdner Hospital
RECRUITING

Nedlands, Western Australia, 6009, Australia
# 6301 West Visayas State University Medical Center
RECRUITING

Iloilo City, 5000, Philippines
# 6302 Baguio General Hospital and Medical Center
WITHDRAWN

Baguio City, 2600, Philippines
# 6303 Lung Center of the Philippines
WITHDRAWN

Quezon City, 1100, Philippines
# 6304 Southern Philippines Medical Center
RECRUITING

Davao City, 8000, Philippines
# 6306 St.Paul's Hospital
WITHDRAWN

Iloilo City, 5000, Philippines
# 6307 Dr. Jose N. Rodriguez Memorial Hospital
RECRUITING

Caloocan, 1427, Philippines
# 6308 Philippine General Hospital
RECRUITING

Manila, 1000, Philippines
# 6309 Davao Doctors Hospital
WITHDRAWN

Davao City, 8000, Philippines
# 6401 Middlemore Hospital
RECRUITING

Otahuhu, 2025, New Zealand
# 6403 Capital, Coast and Hutt Valley District - Wellington Regional Hospital
RECRUITING

Wellington, 6021, New Zealand
# 9701 Bnai Zion Medical Center
WITHDRAWN

Haifa, 31048, Israel
# 9702 Rabin Medical Center
WITHDRAWN

Petah Tikva, 4941492, Israel
# 9703 Rambam Medical Center
WITHDRAWN

Haifa, 31096, Israel
# 9704 Soroka Medical Center
RECRUITING

Beersheba, 8410101, Israel
# 9705 Kaplan Medical Center
RECRUITING

Rehovot, 761001, Israel
# 9706 The Lady Davis Carmel Medical Center
WITHDRAWN

Haifa, 3436212, Israel
# 9707 Tel Aviv Sourasky Medical Center
WITHDRAWN

Tel Aviv, 64239, Israel
# 9708 Shamir Medical Center (Assaf Harofe)
RECRUITING

Rishon LeZiyyon, 70300, Israel
#1007 University of California San Francisco-Fresno
RECRUITING

Fresno, California, 93701, United States
#1009 University of Missouri Clinical Research Center
WITHDRAWN

Columbia, Missouri, 65212, United States
#1012 Pulmonary Associates of Mobile, P.C.
WITHDRAWN

Mobile, Alabama, 36608, United States
#4201 Fakultni nemocnice Kralovske Vinohrady
RECRUITING

Prague, 10034, Czechia
#4202 Fakultni nemocnice u sv. Anny v Brne
RECRUITING

Brno, 65691, Czechia

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