AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Last updated: January 30, 2026
Sponsor: University of Manitoba
Overall Status: Active - Recruiting

Phase

3

Condition

Pneumonia

Pneumonia (Pediatric)

Treatment

Heparin

Clinical Study ID

NCT05848713
ATTACC-CAP
OZM-129
  • Ages > 18
  • All Genders

Study Summary

This is an international, open-label, stratified randomized controlled trial with Bayesian adaptive stopping rules to compare the effects of therapeutic-dose heparin vs. usual care pharmacological thromboprophylaxis on outcomes in patients admitted to hospital with community acquired pneumonia (CAP).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients ≥18 years of age

  2. Admitted to hospital for a suspected or confirmed diagnosis of CAP defined by:

  3. Radiographic evidence of new or worsening infiltrate

  4. One or more of the following signs and/or symptoms of lower respiratory tractinfection i. New or increased cough or sputum production ii. Fever of > 37.8C or temperature < 36C iii. WBC > 11 x 109/L or < 4 x 109/L c. The primary diagnosis is believed to beCAP as per the attending physician

  5. Requires supplemental oxygen to treat hypoxemia (or requires an increased level ofsupplemental oxygen if on chronic oxygen therapy)

  6. Hospital admission anticipated to last ≥72 hours from randomization

Exclusion

Exclusion Criteria:

  1. Suspected or confirmed active COVID-19 infection

  2. Hospital admission for >72 hours prior to randomization

  3. Patients receiving non-invasive or invasive ventilation, vasopressors, orextracorporeal life support (ECLS) within an ICU at the time of enrollment

  4. Requirement for chronic mechanical ventilation via tracheostomy prior tohospitalization

  5. Patients for whom the intent is to not use pharmacologic thromboprophylaxis

  6. Patients with an independent indication for therapeutic-dose anticoagulation

  7. Patients with a contraindication to therapeutic-dose anticoagulation, including:

  8. Non-traumatic bleeding that requires medical evaluation or hospitalizationwithin 30 days prior to CAP hospital admission

  9. History of an inherited or acquired bleeding disorder

  10. Cerebral aneurysm or mass lesions of the central nervous system

  11. Ischemic stroke within 3 months of hospital admission

  12. Gastrointestinal bleeding within 3 months of hospital admission

  13. Platelet count <50 x109/L OR INR >2.0 OR hemoglobin <80 g/L at the time ofscreening

  14. Other physician-perceived contraindications to therapeutic anticoagulation

  15. History of heparin induced thrombocytopenia (HIT) or other heparin allergy

  16. Current or recent (within 7 days of screening) use of dual anti-platelet inhibitors (For example; Aspirin + one of the following; clopidogrel, ticagrelor, prasugrel)

  17. Patients in whom imminent death is anticipated

  18. Anticipated transfer to another hospital that is not a study site within 72 hours ofrandomization

  19. Enrollment in other interventional trials related to anticoagulation or antiplatelettherapy during current hospitalization

Study Design

Total Participants: 4000
Treatment Group(s): 1
Primary Treatment: Heparin
Phase: 3
Study Start date:
October 10, 2023
Estimated Completion Date:
March 31, 2029

Study Description

The global incidence of hospitalization due to CAP is high and associated with substantive morbidity and mortality. Thrombotic complications - including venous, arterial, and possibly microvascular - occur commonly in hospitalized patients across many etiologies of CAP. Poor outcomes may be mediated by both inflammatory and thrombotic processes leading to respiratory, cardiac, and other end organ dysfunction. There are currently no established therapies that modify the potentially maladaptive immunothrombosis pathway in CAP.

Therapeutic-dose anticoagulation with heparin reduces disease progression and mortality in non-critically ill patients hospitalized with COVID-19 with an acceptable safety profile. COVID-19 shares pathogenic features, including activation of the inflammatory and coagulation cascades, with other pneumonias. Whether therapeutic-dose heparin confers similar clinical benefits in non-COVID-19 CAP is unknown.

Connect with a study center

  • Santa Casa de Misericordia de Itabuna

    Itabuna, BA
    Brazil

    Site Not Available

  • Hospital Brasilia

    Brasília, DF
    Brazil

    Site Not Available

  • Hospital Sao Brasilia

    Brasília, DF
    Brazil

    Site Not Available

  • Instituto de Cardiologia e Transplantes do Distrito Federal

    Brasília, DF
    Brazil

    Active - Recruiting

  • Hospital Estadual Dr. Jayme Santos Neves

    Serra, ES 29166-828
    Brazil

    Site Not Available

  • Hospital Evangelico de Vila Velha

    Vila Velha, ES
    Brazil

    Site Not Available

  • Hospital Universitário Cassiano Antonio Moraes

    Vitória, ES
    Brazil

    Site Not Available

  • Hospital Estadual Dr. Jayme Santos Neves

    Serra 3447779, Espírito Santo 3463930 29166-828
    Brazil

    Active - Recruiting

  • Hospital Evangelico de Vila Velha

    Vila Velha 3445026, Espírito Santo 3463930
    Brazil

    Active - Recruiting

  • Hospital Universitário Cassiano Antonio Moraes

    Vitória 3444924, Espírito Santo 3463930
    Brazil

    Site Not Available

  • Santa Casa de Misericordia de Itabuna

    Itabuna 3460949, Estado de Bahia 3471168
    Brazil

    Completed

  • Hospital Brasilia

    Brasília 3469058, Federal District 3463504
    Brazil

    Completed

  • Hospital Sao Brasilia

    Brasília 3469058, Federal District 3463504
    Brazil

    Site Not Available

  • Instituto de Cardiologia e Transplantes do Distrito Federal

    Brasília 3469058, Federal District 3463504
    Brazil

    Active - Recruiting

  • Instituto Goiano de Oncologia e Hematologia - INGOH

    Goiania, GO
    Brazil

    Site Not Available

  • Hospital Ruy Azeredo

    Goiânia, GO
    Brazil

    Site Not Available

  • Hospital de Messejana Dr. Carlos Alberto Studart Gomes

    Goiânia, GO
    Brazil

    Active - Recruiting

  • Hospital Ruy Azeredo

    Goiânia 3462377, Goiás 3462372
    Brazil

    Active - Recruiting

  • Hospital de Messejana Dr. Carlos Alberto Studart Gomes

    Goiânia 3462377, Goiás 3462372
    Brazil

    Active - Recruiting

  • Instituto Goiano de Oncologia e Hematologia - INGOH

    Goiânia 3462377, Goiás 3462372
    Brazil

    Active - Recruiting

  • Hospital Felicio Rocho

    Belo Horizonte, MG
    Brazil

    Site Not Available

  • NUPEC-Orizonti

    Belo Horizonte, MG
    Brazil

    Active - Recruiting

  • Hospital do Coração - MS

    Campo Grande, MS
    Brazil

    Site Not Available

  • Hospital Felicio Rocho

    Belo Horizonte 3470127, Minas Gerais 3457153
    Brazil

    Active - Recruiting

  • NUPEC-Orizonti

    Belo Horizonte 3470127, Minas Gerais 3457153
    Brazil

    Completed

  • Hospital Agamenon Magalhães

    Recife, PE 52070-230
    Brazil

    Site Not Available

  • Hospital Angelina Caron

    Curitiba, PR
    Brazil

    Site Not Available

  • Hospital Santa Cruz

    Curitiba, PR
    Brazil

    Site Not Available

  • PUCPR

    Curitiba, PR
    Brazil

    Active - Recruiting

  • Hospital Santa Cruz

    Curitiba 3464975, Paraná 3455077
    Brazil

    Active - Recruiting

  • PUCPR

    Curitiba 3464975, Paraná 3455077
    Brazil

    Completed

  • Hospital Universitário de Canoas

    Canoas, RS
    Brazil

    Site Not Available

  • Hospital Bruno Born

    Lajeado, RS
    Brazil

    Site Not Available

  • Hospital Sao Vicente de Paulo

    Passo Fundo, RS
    Brazil

    Site Not Available

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, RS
    Brazil

    Site Not Available

  • Hospital Universitario de Santa Maria

    Santa Maria, RS
    Brazil

    Site Not Available

  • Hospital Bruno Born

    Lajeado 3459035, Rio Grande do Sul 3451133
    Brazil

    Active - Recruiting

  • Hospital Sao Vicente de Paulo

    Passo Fundo 3454857, Rio Grande do Sul 3451133
    Brazil

    Active - Recruiting

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre 3452925, Rio Grande do Sul 3451133
    Brazil

    Active - Recruiting

  • Hospital Universitario de Santa Maria

    Santa Maria 3450083, Rio Grande do Sul 3451133
    Brazil

    Active - Recruiting

  • Hospital Sao Jose

    Criciúma, SC
    Brazil

    Site Not Available

  • Hospital Regional Homero Miranda Gomes

    São José, SC
    Brazil

    Site Not Available

  • Hospital de Reabilitacao de Anomalias Craniofaciais

    Bauru, SP
    Brazil

    Site Not Available

  • UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu

    Botucatu, SP
    Brazil

    Site Not Available

  • Fundação Centro Médico de Campinas

    Campinas, SP 13083-190
    Brazil

    Site Not Available

  • IPECC

    Campinas, SP
    Brazil

    Active - Recruiting

  • UNIMAR

    Marília, SP
    Brazil

    Site Not Available

  • Hospital Regional de Presidente Prudente

    Presidente Prudente, SP
    Brazil

    Site Not Available

  • Hospital Estadual de Serrana

    Ribeirão Preto, SP
    Brazil

    Site Not Available

  • CRT-AIDS Santa Cruz

    São Paulo, SP
    Brazil

    Site Not Available

  • Hospital Municipal Bela Vista

    São Paulo, SP
    Brazil

    Site Not Available

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, SP
    Brazil

    Site Not Available

  • Santa Casa de Misericordia de Sao Paulo

    São Paulo, SP
    Brazil

    Active - Recruiting

  • UNIFESP

    São Paulo, SP
    Brazil

    Site Not Available

  • Hospital Sao Jose

    Criciúma 3465196, Santa Catarina 3450387
    Brazil

    Active - Recruiting

  • Hospital Universitario Sao Francisco na Providencia na Deus

    Bragança Paulista, Sao Paulo
    Brazil

    Site Not Available

  • CiTen - Centro Hospital Municipal Antonio Giglio

    Osasco, Sao Paulo
    Brazil

    Site Not Available

  • Hospital Regional Homero Miranda Gomes

    São José 3448744, South Carolina
    Brazil

    Completed

  • Hospital de Reabilitacao de Anomalias Craniofaciais

    Bauru 3470279, São Paulo 3448433
    Brazil

    Site Not Available

  • UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu

    Botucatu 3469136, São Paulo 3448433
    Brazil

    Active - Recruiting

  • Hospital Universitario Sao Francisco na Providencia na Deus

    Bragança Paulista 3469092, São Paulo 3448433
    Brazil

    Active - Recruiting

  • Fundação Centro Médico de Campinas

    Campinas 3467865, São Paulo 3448433 13083-190
    Brazil

    Active - Recruiting

  • IPECC

    Campinas 3467865, São Paulo 3448433
    Brazil

    Active - Recruiting

  • CiTen - Centro Hospital Municipal Antonio Giglio

    Osasco 3455775, São Paulo 3448433
    Brazil

    Active - Recruiting

  • Hospital Regional de Presidente Prudente

    Presidente Prudente 3452324, São Paulo 3448433
    Brazil

    Active - Recruiting

  • Hospital Estadual de Serrana

    Ribeirão Preto 3451328, São Paulo 3448433
    Brazil

    Site Not Available

  • HCFMUSP

    São Paulo 3448439, São Paulo 3448433 05403-010
    Brazil

    Active - Recruiting

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo 3448439, São Paulo 3448433
    Brazil

    Site Not Available

  • Santa Casa de Misericordia de Sao Paulo

    São Paulo 3448439, São Paulo 3448433
    Brazil

    Active - Recruiting

  • HCFMUSP

    São Paulo, 05403-010
    Brazil

    Site Not Available

  • Foothills Medical Centre

    Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • Grand Prairie Regional Hospital

    Grande Prairie, Alberta T8V 4B1
    Canada

    Site Not Available

  • Foothills Medical Centre

    Calgary 5913490, Alberta 5883102 T2N 2T9
    Canada

    Active - Recruiting

  • Grand Prairie Regional Hospital

    Grande Prairie 5964347, Alberta 5883102 T8V 4B1
    Canada

    Site Not Available

  • East Kootenay Regional Hospital

    Cranbrook, British Columbia V1C 3H9
    Canada

    Site Not Available

  • Nanaimo Regional General Hospital

    Nanaimo, British Columbia
    Canada

    Site Not Available

  • Penticton Regional Hospital

    Penticton, British Columbia V2A 3G6
    Canada

    Site Not Available

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Nanaimo Regional General Hospital

    Nanaimo 6085772, British Columbia 5909050
    Canada

    Active - Recruiting

  • Vancouver General Hospital

    Vancouver 6173331, British Columbia 5909050 V5Z 1M9
    Canada

    Active - Recruiting

  • Grace General Hospital

    Winnipeg, Manitoba
    Canada

    Active - Recruiting

  • Health Sciences Center Winnipeg

    Winnipeg, Manitoba R3A 1R9
    Canada

    Site Not Available

  • St. Boniface General Hospital

    Winnipeg, Manitoba
    Canada

    Active - Recruiting

  • Grace General Hospital

    Winnipeg 6183235, Manitoba 6065171
    Canada

    Active - Recruiting

  • Health Sciences Center Winnipeg

    Winnipeg 6183235, Manitoba 6065171 R3A 1R9
    Canada

    Active - Recruiting

  • St. Boniface General Hospital

    Winnipeg 6183235, Manitoba 6065171
    Canada

    Active - Recruiting

  • Memorial University

    Saint John's, Newfoundland and Labrador A1C 5S7
    Canada

    Site Not Available

  • Memorial University

    St. John's 6324733, Newfoundland and Labrador 6354959 A1C 5S7
    Canada

    Active - Recruiting

  • Hamilton Health Sciences

    Hamilton, Ontario
    Canada

    Site Not Available

  • Hamilton Health Sciences - Juravinski

    Hamilton, Ontario
    Canada

    Active - Recruiting

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario
    Canada

    Site Not Available

  • Kingston General Hospital

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • Markham Stouffville Hospital

    Markham, Ontario L3P 7P3
    Canada

    Site Not Available

  • Hôpital Montfort

    Ottawa, Ontario
    Canada

    Site Not Available

  • The Ottawa Hospital

    Ottawa, Ontario
    Canada

    Site Not Available

  • Niagara Health System - St Catharines Site

    St. Catherines, Ontario L2S 0A9
    Canada

    Site Not Available

  • Health Sciences North Research Institute

    Sudbury, Ontario P3E 2H3
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • University Health Network

    Toronto, Ontario M5G2C4
    Canada

    Site Not Available

  • Health Sciences North Research Institute

    Greater Sudbury 5964700, Ontario 6093943 P3E 2H3
    Canada

    Active - Recruiting

  • Hamilton Health Sciences

    Hamilton 5969782, Ontario 6093943
    Canada

    Active - Recruiting

  • Hamilton Health Sciences - Juravinski

    Hamilton 5969782, Ontario 6093943
    Canada

    Active - Recruiting

  • Markham Stouffville Hospital

    Markham 6066513, Ontario 6093943 L3P 7P3
    Canada

    Active - Recruiting

  • Hôpital Montfort

    Ottawa 6094817, Ontario 6093943
    Canada

    Active - Recruiting

  • The Ottawa Hospital

    Ottawa 6094817, Ontario 6093943
    Canada

    Active - Recruiting

  • Niagara Health System - St Catharines Site

    Saint Catherines, Ontario 6093943 L2S 0A9
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto 6167865, Ontario 6093943 M4N 3M5
    Canada

    Active - Recruiting

  • University Health Network

    Toronto 6167865, Ontario 6093943 M5G2C4
    Canada

    Site Not Available

  • Centre Hospitalier de Quebec - Hotel-Dieu de Levis

    Lévis, Quebec G6V 3Z1
    Canada

    Site Not Available

  • Centre Hospitalier de l'université de Montréal (CHUM)

    Montréal, Quebec
    Canada

    Active - Recruiting

  • Jewish General Hospital

    Montréal, Quebec
    Canada

    Active - Recruiting

  • McGill University Health Centre

    Montréal, Quebec H4A3J1
    Canada

    Site Not Available

  • CHU de Quebec-University Laval

    Québec, Quebec
    Canada

    Active - Recruiting

  • Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ)

    Québec, Quebec
    Canada

    Site Not Available

  • Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

    Québec, Quebec
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec
    Canada

    Site Not Available

  • Centre Hospitalier de Quebec - Hotel-Dieu de Levis

    Lévis 6325521, Quebec 6115047 G6V 3Z1
    Canada

    Site Not Available

  • Centre Hospitalier de l'université de Montréal (CHUM)

    Montreal 6077243, Quebec 6115047
    Canada

    Active - Recruiting

  • Jewish General Hospital

    Montreal 6077243, Quebec 6115047
    Canada

    Active - Recruiting

  • McGill University Health Centre

    Montreal 6077243, Quebec 6115047 H4A3J1
    Canada

    Active - Recruiting

  • CHU de Quebec-University Laval

    Québec 6325494, Quebec 6115047
    Canada

    Active - Recruiting

  • Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

    Québec 6325494, Quebec 6115047
    Canada

    Active - Recruiting

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke 6146143, Quebec 6115047
    Canada

    Active - Recruiting

  • Regina General Hospital

    Regina, Saskatchewan S4P 0W5
    Canada

    Site Not Available

  • Regina General Hospital

    Regina 6119109, Saskatchewan 6141242 S4P 0W5
    Canada

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Ochsner Clinic

    Jefferson, Louisiana 70121
    United States

    Site Not Available

  • Ochsner Clinic

    Jefferson 4328973, Louisiana 4331987 70121
    United States

    Active - Recruiting

  • Maine Medical Center

    Portland, Maine 04102
    United States

    Site Not Available

  • Maine Medical Centre

    Portland, Maine 04102
    United States

    Site Not Available

  • Maine Medical Centre

    Portland 4975802, Maine 4971068 04102
    United States

    Active - Recruiting

  • Henry Ford University

    Dearborn, Michigan 48128
    United States

    Site Not Available

  • Henry Ford Health System

    Dearborn 4990510, Michigan 5001836 48128
    United States

    Completed

  • Cooper University Health Care

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Cooper University Health Care

    Camden 4501018, New Jersey 5101760 08103
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Active - Recruiting

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