What side effects are associated with this type of intervention?

Common treatments for Community-acquired Pneumonia (CAP) include antibiotics and immunomodulatory agents like Trimodulin. Antibiotics can cause gastrointestinal disturbances, allergic reactions, and antibiotic resistance. Immunomodulatory agents may lead to infusion reactions, increased risk of infections, and potential allergic reactions. Monitoring and managing these side effects is crucial for patient safety.

What prior FDA approvals exist?

The FDA has approved several treatments for community-acquired pneumonia (CAP), primarily focusing on antibiotics to target the bacterial causes of the infection. However, immunomodulatory agents similar to Trimodulin, which modulate the immune response to reduce inflammation and improve infection control, are less commonly used. One example of an immunomodulatory approach is the use of corticosteroids in severe cases of CAP to reduce inflammation. While Trimodulin is still under investigation, its approach represents a novel strategy in managing CAP by enhancing the body's immune response rather than directly targeting the pathogens.

What other types of research exist?

Promising novel alternatives to Trimodulin for community-acquired pneumonia patients include: 1) Azithromycin, which has anti-inflammatory properties and enhances the immune response against infections. 2) High-dose ibuprofen, which has shown effectiveness in reducing inflammation in cystic fibrosis patients and could be considered for CAP. 3) Inhaled corticosteroids, which have been used to manage lung infections and inflammation. Further clinical trials and studies are needed to confirm their efficacy specifically for CAP.

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Trimodulin for Severe Community-acquired Pneumonia (ESsCAPE Trial)

Phase 3

Recruiting

Led By Ricard Ferrer Roca, Dr.

Research Sponsored by Biotest

Eligibility Criteria Checklist

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

Must have

Diagnosis of active pneumonia

Acute respiratory failure requiring IMV

Must not have

Ongoing treatment with immunosuppressants other than guideline recommended immunosuppressants for treatment of active pneumonia

Known treatment for thorax/head/neck/hematologic malignancies in the last 12 months before screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, 2, 3, 4, 5, 6, 7, 9, 14, 21, 29

Awards & highlights

Pivotal Trial

Summary

This trial tests if trimodulin, added to usual care, helps adults with severe lung infections who need breathing machines recover faster by boosting their immune system.

Who is the study for?

Adults hospitalized with severe community-acquired pneumonia who need mechanical ventilation can join this trial. They must not have COVID-19, should show signs of inflammation, and agree to use contraception. Excluded are those with severe kidney or liver issues, certain blood disorders, obesity or malnutrition extremes, other serious lung diseases or heart failure, recent cancer treatments outside the lungs/head/neck area, and those on specific medications.

What is being tested?

The trial is testing Trimodulin as an extra treatment alongside standard care for adults with severe pneumonia requiring breathing support compared to a placebo plus standard care. It also looks at how the body processes Trimodulin and its effects on the disease.

What are the potential side effects?

Possible side effects include allergic reactions to human proteins in Trimodulin or infusion-related reactions. Since it's being tested against a placebo that has no active ingredients, any additional side effects will be monitored during the trial.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with active pneumonia.

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I need a machine to help me breathe due to severe lung problems.

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I am an adult currently in the hospital.

Exclusion Criteria

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

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I am not on immunosuppressants, except for those prescribed for pneumonia.

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I haven't had treatments for cancers in the chest, head, neck, or blood in the last year.

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I do not have severe lung diseases that would affect my treatment.

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I am on dialysis or have severe kidney problems.

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I have a condition that breaks down my red blood cells.

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My BMI is either above 40 or below 16.

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I am suspected to have pneumonia acquired from a hospital stay.

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I have end-stage kidney disease or a specific kidney condition called FSGS.

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I have been diagnosed with severe heart failure.

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I have not taken certain medications in the last 5 days.

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I have severe liver problems or liver cancer.

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I have a history of blood clots or am at high risk for them.

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I have not received immunoglobulin, plasma, or albumin treatments in the last 21 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, 2, 3, 4, 5, 6, 7, 9, 14, 21, 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, 2, 3, 4, 5, 6, 7, 9, 14, 21, 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 2, 3, 4, 5, 6, 7, 9, 14, 21, 29 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

28-day all-cause mortality rate

Secondary study objectives

28-day all-cause mortality rate plus day 1-29 deterioration rate

28-day all-cause mortality rate plus day 6-29 deterioration rate

28-day readmission rate

+28 more

Other study objectives

Pharmacodynamic assessment of disease related serum proteins

Pharmacokinetic assessment of immunoglobulins

Serum concentration of immunoglobulins

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TrimodulinExperimental Treatment1 Intervention

Trimodulin (human IgM, IgA, IgG solution) for intravenous (IV) administration.

Group II: PlaceboPlacebo Group1 Intervention

Human albumin 1%

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trimodulin

2020

Completed Phase 2

~170

0 / 16Eligibility 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

Common treatments for Community-acquired Pneumonia (CAP) include antibiotics and immunomodulatory agents. Antibiotics target and eliminate the bacteria causing the infection, which is essential for clearing the infection and preventing complications. Immunomodulatory agents, such as Trimodulin, work by modulating the immune response to reduce excessive inflammation and enhance infection control. This dual approach is significant for CAP patients as it addresses both the bacterial cause and the inflammatory response, potentially reducing tissue damage and improving overall patient outcomes.