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New treatment option for Community-acquired Pneumonia
Official title AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
ClinicalTrials.gov ID: NCT05848713
What this study is testing
What is Heparin?
Heparin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for community-acquired pneumonia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Requires supplemental oxygen to treat hypoxemia (or requires an increased level of supplemental oxygen if on chronic oxygen therapy)
You likely can't join if
- Suspected or confirmed active COVID-19 infection
- Hospital admission for \>72 hours prior to randomization
- Patients receiving non-invasive or invasive ventilation, vasopressors, or extracorporeal life support (ECLS) within an ICU at the time of enrollment
- Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
- Patients for whom the intent is to not use pharmacologic thromboprophylaxis
- Patients with an independent indication for therapeutic-dose anticoagulation
See the full eligibility criteria
- 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 \ 11 x 109/L or \< 4 x 109/L c. The primary...
- 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
- Suspected or confirmed active COVID-19 infection
- Hospital admission for \>72 hours prior to randomization
- Patients receiving non-invasive or invasive ventilation, vasopressors, or extracorporeal life support (ECLS) within an ICU at the time of enrollment
- Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
- Patients for whom the intent is to not use pharmacologic thromboprophylaxis
- Patients with an independent indication for therapeutic-dose anticoagulation
- Patients with a contraindication to therapeutic-dose anticoagulation, including:
- Non-traumatic bleeding that requires medical evaluation or hospitalization within 30 days prior to CAP hospital admission
- History of an inherited or acquired bleeding disorder
- Cerebral aneurysm or mass lesions of the central nervous system
- Ischemic stroke within 3 months of hospital admission
- Gastrointestinal bleeding within 3 months of hospital admission
- Platelet count \ 2.0 OR hemoglobin \<80 g/L at the time of screening
- Other physician-perceived contraindications to therapeutic anticoagulation
- History of heparin induced thrombocytopenia (HIT) or other heparin allergy
- Current or recent (within 7 days of screening) use of dual anti-platelet inhibitors (For example; Aspirin + one of the following; clopidogrel, ticagrelor, prasugrel)
- Patients in whom imminent death is anticipated
- Anticipated transfer to another hospital that is not a study site within 72 hours of randomization
- Enrollment in other treatment trials related to anticoagulation or antiplatelet therapy during current hospitalization
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Jefferson, Louisiana, United States
- Portland, Maine, United States
- Dearborn, Michigan, United States
- Camden, New Jersey, United States
- Milwaukee, Wisconsin, United States
- Serra, Espírito Santo, Brazil
- Vila Velha, Espírito Santo, Brazil
- Vitória, Espírito Santo, Brazil
- Itabuna, Estado de Bahia, Brazil
- Brasília, Federal District, Brazil
- Goiânia, Goiás, Brazil
- Belo Horizonte, Minas Gerais, Brazil
- Campo Largo, Paraná, Brazil
- Curitiba, Paraná, Brazil
- Lajeado, Rio Grande do Sul, Brazil
- Passo Fundo, Rio Grande do Sul, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Santa Maria, Rio Grande do Sul, Brazil
- Criciúma, Santa Catarina, Brazil
+ 26 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Jefferson, Louisiana, United States; Portland, Maine, United States; Dearborn, Michigan, United States; Camden, New Jersey, United States; Milwaukee, Wisconsin, United States and 40 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.