AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Status: Recruiting
Location: See all (62) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients ≥18 years of age

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

‣ Radiographic evidence of new or worsening infiltrate

⁃ One or more of the following signs and/or symptoms of lower respiratory tract infection

• 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 be CAP as per the attending physician

• Requires supplemental oxygen to treat hypoxemia (or requires an increased level of supplemental oxygen if on chronic oxygen therapy)

• Hospital admission anticipated to last ≥72 hours from randomization

Locations
United States
Illinois
University of Chicago
NOT_YET_RECRUITING
Chicago
Louisiana
Ochsner Clinic
RECRUITING
Jefferson
Maine
Maine Medical Centre
RECRUITING
Portland
Michigan
Henry Ford University
RECRUITING
Dearborn
New Jersey
Cooper University Health Care
RECRUITING
Camden
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Brazil
Hospital de Reabilitacao de Anomalias Craniofaciais
NOT_YET_RECRUITING
Bauru
Hospital Felicio Rocho
RECRUITING
Belo Horizonte
NUPEC-Orizonti
RECRUITING
Belo Horizonte
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu
RECRUITING
Botucatu
Hospital Universitario Sao Francisco na Providencia na Deus
RECRUITING
Bragança Paulista
Hospital Brasilia
NOT_YET_RECRUITING
Brasília
Hospital Sao Brasilia
NOT_YET_RECRUITING
Brasília
Instituto de Cardiologia e Transplantes do Distrito Federal
RECRUITING
Brasília
Fundação Centro Médico de Campinas
RECRUITING
Campinas
IPECC
RECRUITING
Campinas
Hospital Sao Jose
RECRUITING
Criciúma
Hospital Santa Cruz
RECRUITING
Curitiba
PUCPR
RECRUITING
Curitiba
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
RECRUITING
Goiânia
Hospital Ruy Azeredo
RECRUITING
Goiânia
Instituto Goiano de Oncologia e Hematologia - INGOH
RECRUITING
Goiânia
Santa Casa de Misericordia de Itabuna
RECRUITING
Itabuna
Hospital Bruno Born
RECRUITING
Lajeado
CiTen - Centro Hospital Municipal Antonio Giglio
RECRUITING
Osasco
Hospital Sao Vicente de Paulo
RECRUITING
Passo Fundo
Hospital de Clínicas de Porto Alegre
RECRUITING
Porto Alegre
Hospital Regional de Presidente Prudente
RECRUITING
Presidente Prudente
Hospital Estadual de Serrana
NOT_YET_RECRUITING
Ribeirão Preto
Hospital Universitario de Santa Maria
RECRUITING
Santa Maria
Hospital Regional Homero Miranda Gomes
RECRUITING
São José
HCFMUSP
RECRUITING
São Paulo
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
NOT_YET_RECRUITING
São Paulo
Santa Casa de Misericordia de Sao Paulo
RECRUITING
São Paulo
Hospital Estadual Dr. Jayme Santos Neves
RECRUITING
Serra
Hospital Evangelico de Vila Velha
RECRUITING
Vila Velha
Hospital Universitário Cassiano Antonio Moraes
NOT_YET_RECRUITING
Vitória
Canada
Foothills Medical Centre
RECRUITING
Calgary
Grand Prairie Regional Hospital
NOT_YET_RECRUITING
Grande Prairie
Health Sciences North Research Institute
RECRUITING
Greater Sudbury
Hamilton Health Sciences
RECRUITING
Hamilton
Hamilton Health Sciences - Juravinski
RECRUITING
Hamilton
Centre Hospitalier de Quebec - Hotel-Dieu de Levis
NOT_YET_RECRUITING
Lévis
Markham Stouffville Hospital
RECRUITING
Markham
Centre Hospitalier de l'université de Montréal (CHUM)
RECRUITING
Montreal
Jewish General Hospital
RECRUITING
Montreal
McGill University Health Centre
RECRUITING
Montreal
Nanaimo Regional General Hospital
RECRUITING
Nanaimo
Hôpital Montfort
NOT_YET_RECRUITING
Ottawa
The Ottawa Hospital
RECRUITING
Ottawa
CHU de Quebec-University Laval
RECRUITING
Québec
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
RECRUITING
Québec
Regina General Hospital
NOT_YET_RECRUITING
Regina
Niagara Health System - St Catharines Site
RECRUITING
Saint Catherines
Centre Hospitalier Universitaire de Sherbrooke
RECRUITING
Sherbrooke
Memorial University
RECRUITING
St. John's
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
University Health Network
NOT_YET_RECRUITING
Toronto
Vancouver General Hospital
RECRUITING
Vancouver
Grace General Hospital
RECRUITING
Winnipeg
Health Sciences Center Winnipeg
RECRUITING
Winnipeg
St. Boniface General Hospital
RECRUITING
Winnipeg
Contact Information
Primary
Chantale Pineau
attacc.cap@umanitoba.ca
2042353223
Time Frame
Start Date: 2023-10-10
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 4000
Treatments
Experimental: Therapeutic-Dose Heparin
Participants randomized to the investigational arm will receive a pragmatic strategy of therapeutic-dose low molecular-weight heparin (LMWH) or unfractionated heparin (UFH) administered daily for up to 14 days or until hospital discharge, whichever occurs first. Participants should start receiving study drug as soon as possible following randomization.
No_intervention: Usual Care
Participants randomized to the control arm will receive usual care thromboprophylactic dose anticoagulation according to local practice. To ensure adequate separation between the study groups, the dose of heparin/LMWH used in the usual care arm should not equal more than half of the approved therapeutic dose for that agent according to local VTE treatment protocols.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Canadian Critical Care Trials Group, Research Manitoba, AVANTI, Ozmosis Research Inc., Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
Leads: University of Manitoba

This content was sourced from clinicaltrials.gov