AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Last updated: May 9, 2025
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

    Active - Recruiting

  • 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

    Active - Recruiting

  • Hospital Evangelico de Vila Velha

    Vila Velha, ES
    Brazil

    Active - Recruiting

  • Hospital Universitário Cassiano Antonio Moraes

    Vitória, ES
    Brazil

    Site Not Available

  • Instituto Goiano de Oncologia e Hematologia - INGOH

    Goiania, GO
    Brazil

    Active - Recruiting

  • Hospital Ruy Azeredo

    Goiânia, GO
    Brazil

    Active - Recruiting

  • Hospital de Messejana Dr. Carlos Alberto Studart Gomes

    Goiânia, GO
    Brazil

    Active - Recruiting

  • Hospital Felicio Rocho

    Belo Horizonte, MG
    Brazil

    Active - Recruiting

  • NUPEC-Orizonti

    Belo Horizonte, MG
    Brazil

    Active - Recruiting

  • Hospital do Coração - MS

    Campo Grande, MS
    Brazil

    Site Not Available

  • 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

    Active - Recruiting

  • PUCPR

    Curitiba, PR
    Brazil

    Active - Recruiting

  • Hospital Universitário de Canoas

    Canoas, RS
    Brazil

    Site Not Available

  • Hospital Bruno Born

    Lajeado, RS
    Brazil

    Active - Recruiting

  • Hospital Sao Vicente de Paulo

    Passo Fundo, RS
    Brazil

    Active - Recruiting

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, RS
    Brazil

    Active - Recruiting

  • Hospital Universitario de Santa Maria

    Santa Maria, RS
    Brazil

    Active - Recruiting

  • Hospital Sao Jose

    Criciúma, SC
    Brazil

    Active - Recruiting

  • Hospital Regional Homero Miranda Gomes

    São José, SC
    Brazil

    Active - Recruiting

  • 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

    Active - Recruiting

  • Fundação Centro Médico de Campinas

    Campinas, SP 13083-190
    Brazil

    Active - Recruiting

  • IPECC

    Campinas, SP
    Brazil

    Active - Recruiting

  • UNIMAR

    Marília, SP
    Brazil

    Site Not Available

  • Hospital Regional de Presidente Prudente

    Presidente Prudente, SP
    Brazil

    Active - Recruiting

  • 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 Universitario Sao Francisco na Providencia na Deus

    Bragança Paulista, Sao Paulo
    Brazil

    Active - Recruiting

  • CiTen - Centro Hospital Municipal Antonio Giglio

    Osasco, Sao Paulo
    Brazil

    Active - Recruiting

  • HCFMUSP

    São Paulo, 05403-010
    Brazil

    Active - Recruiting

  • Foothills Medical Centre

    Calgary, Alberta T2N 2T9
    Canada

    Active - Recruiting

  • Grand Prairie Regional Hospital

    Grande Prairie, Alberta 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

    Active - Recruiting

  • Penticton Regional Hospital

    Penticton, British Columbia V2A 3G6
    Canada

    Site Not Available

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

  • Grace General Hospital

    Winnipeg, Manitoba
    Canada

    Active - Recruiting

  • Health Sciences Center Winnipeg

    Winnipeg, Manitoba R3A 1R9
    Canada

    Active - Recruiting

  • St. Boniface General Hospital

    Winnipeg, Manitoba
    Canada

    Active - Recruiting

  • Memorial University

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

    Active - Recruiting

  • Hamilton Health Sciences

    Hamilton, Ontario
    Canada

    Active - Recruiting

  • 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

    Active - Recruiting

  • Hôpital Montfort

    Ottawa, Ontario
    Canada

    Site Not Available

  • The Ottawa Hospital

    Ottawa, Ontario
    Canada

    Active - Recruiting

  • Niagara Health System - St Catharines Site

    St. Catherines, Ontario L2S 0A9
    Canada

    Active - Recruiting

  • Health Sciences North Research Institute

    Sudbury, Ontario P3E 2H3
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • University Health Network

    Toronto, Ontario 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

    Active - Recruiting

  • 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

    Active - Recruiting

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec
    Canada

    Active - Recruiting

  • Regina General Hospital

    Regina, Saskatchewan S4P 0W5
    Canada

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Ochsner Clinic

    Jefferson, Louisiana 70121
    United States

    Active - Recruiting

  • Maine Medical Center

    Portland, Maine 04102
    United States

    Site Not Available

  • Maine Medical Centre

    Portland, Maine 04102
    United States

    Active - Recruiting

  • Henry Ford University

    Dearborn, Michigan 48128
    United States

    Active - Recruiting

  • Cooper University Health Care

    Camden, New Jersey 08103
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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