What is the mechanism of action of this treatment?

The most common treatments for Community-acquired Pneumonia (CAP) include antibiotics and, in some cases, anticoagulants like therapeutic-dose heparin. Antibiotics work by targeting and eliminating the bacterial pathogens causing the infection, which is essential for resolving the infection and preventing further complications. Therapeutic-dose heparin, an anticoagulant, is being studied for its potential to prevent blood clots in hospitalized CAP patients. This is important because preventing blood clots reduces the risk of venous thromboembolism, a serious condition that can lead to pulmonary embolism and other severe outcomes.

What side effects are associated with this type of intervention?

Common treatments for community-acquired pneumonia (CAP) include antibiotics and anticoagulants like therapeutic-dose heparin. Antibiotics such as macrolides, beta-lactams, and fluoroquinolones can cause gastrointestinal disturbances (nausea, vomiting, diarrhea), allergic reactions, and, in some cases, more severe effects like tendonitis or QT prolongation. Anticoagulants like heparin, used to prevent blood clots, can lead to side effects such as bleeding, thrombocytopenia (low platelet count), and allergic reactions. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved various antibiotics for the treatment of Community-acquired Pneumonia (CAP), such as macrolides (e.g., azithromycin), fluoroquinolones (e.g., levofloxacin), and beta-lactams (e.g., amoxicillin-clavulanate). However, the use of anticoagulants like therapeutic-dose heparin specifically for CAP is investigational. Current studies are exploring the potential benefits of anticoagulants in reducing complications associated with CAP, but they are not yet standard treatment.

What other types of research exist?

Promising novel alternatives to therapeutic-dose heparin for community-acquired pneumonia patients include direct oral anticoagulants (DOACs) such as rivaroxaban, apixaban, and edoxaban. These agents have been studied extensively for various thromboembolic conditions and offer the advantage of oral administration and fewer monitoring requirements compared to heparin. Additionally, ongoing research into newer anticoagulants and anti-inflammatory agents may provide further options in the near future.

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Anticoagulant

Heparin for Community-Acquired Pneumonia (ATTACC-CAP Trial)

Phase 3

Recruiting

Led By Alexis Turgeon, MD

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admitted to hospital for a suspected or confirmed diagnosis of CAP defined by radiographic evidence of new or worsening infiltrate and one or more of the following signs and/or symptoms of lower respiratory tract infection

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

Must not have

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

Patients with an independent indication for therapeutic-dose anticoagulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days, 90 days, and 180 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if higher doses of heparin, a blood thinner, can help patients hospitalized with pneumonia. These patients often have blood clot complications that worsen their condition. By preventing these clots, heparin might improve their recovery and reduce severe outcomes. Heparin has been shown to reduce the risk of blood clots in various patients, including those hospitalized for medical conditions and surgeries.

Who is the study for?

Adults hospitalized with community-acquired pneumonia (CAP) needing oxygen, expected to stay at least 72 hours post-randomization. They must have a primary diagnosis of CAP with new or worsening lung infiltrates and symptoms of lower respiratory infection. Excluded are those admitted over 72 hours, on chronic ventilation, not using thromboprophylaxis, needing full anticoagulation for other reasons, suspected COVID-19, in ICU on life support measures at enrollment time, or with bleeding risks.

What is being tested?

The trial is testing if therapeutic-dose heparin improves outcomes compared to standard care in hospitalized patients with CAP. It's an international study where participants are randomly assigned to receive either heparin or usual care and the results will be evaluated adaptively as they come in.

What are the potential side effects?

Heparin can cause bleeding problems including bruising easily and prolonged bleeding from cuts. Some may experience allergic reactions like rashes or itching. Rarely it can lead to a drop in platelets causing clotting issues known as HIT (heparin-induced thrombocytopenia).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am in the hospital with pneumonia confirmed by a lung scan and symptoms.

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I need extra oxygen to help me breathe.

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I expect to stay in the hospital for at least 3 days after being assigned to a study group.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am in the ICU receiving support like ventilation or ECLS.

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I need blood thinners for a health condition unrelated to the trial.

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I am not planned to be given drugs to prevent blood clots.

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I cannot take strong blood thinners due to my medical history or current conditions.

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I have been in the hospital for more than 3 days before joining the study.

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I needed a machine to help me breathe through a tube in my neck before I was hospitalized.

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I currently have or am suspected to have COVID-19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days, 90 days, and 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days, 90 days, and 180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, 90 days, and 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ordinal endpoint reflecting survival

Secondary study objectives

Bleeding events

HIT events

Health related quality of life

+3 more

Side effects data

From 2008 Phase 4 trial • 541 Patients • NCT00277394

Urinary tract infection

Haematoma

Constipation

Diarrhoea

Pain in extremity

Cardiac failure

Deep vein thrombosis

Subcutaneous haematoma

Left ventricular failure

Melaena

General physical health deterioration

Sudden death

Multi-organ failure

Death

Fall

Coagulation time prolonged

Metastatic neoplasm

International normalised ratio increased

Lung neoplasm malignant

Depression

Respiratory failure

Pulmonary embolism

Anaemia

Rectal haemorrhage

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Innohep®

Heparin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Therapeutic-Dose HeparinExperimental Treatment1 Intervention

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.

Group II: Usual CareActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Heparin

2003

Completed Phase 4

~22600

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Community-acquired Pneumonia (CAP) include antibiotics and, in some cases, anticoagulants like therapeutic-dose heparin. Antibiotics work by targeting and eliminating the bacterial pathogens causing the infection, which is essential for resolving the infection and preventing further complications. Therapeutic-dose heparin, an anticoagulant, is being studied for its potential to prevent blood clots in hospitalized CAP patients. This is important because preventing blood clots reduces the risk of venous thromboembolism, a serious condition that can lead to pulmonary embolism and other severe outcomes.