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Trimodulin for Severe Community-acquired Pneumonia (ESsCAPE Trial)

Phase 3

Recruiting

Led By Tobias Welte, Prof.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

ESsCAPE Trial Summary

This trial will assess the safety and effectiveness of a new drug (trimodulin) to help adults with severe pneumonia on mechanical ventilation.

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.Check my eligibility

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.See study design

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.

ESsCAPE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with active pneumonia.

Select...

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

Select...

I am an adult currently in the hospital.

ESsCAPE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

28-day all-cause mortality rate

Secondary outcome measures

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 outcome measures

Pharmacodynamic assessment of disease related serum proteins

Pharmacokinetic assessment of immunoglobulins

Serum concentration of immunoglobulins

ESsCAPE 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

BiotestLead Sponsor

21 Previous Clinical Trials

2,257 Total Patients Enrolled

1 Trials studying Community-acquired Pneumonia

390 Patients Enrolled for Community-acquired Pneumonia

Tobias Welte, Prof.Principal InvestigatorHannover Medical School

1 Previous Clinical Trials

290 Total Patients Enrolled

Media Library

Community-acquired Pneumonia Research Study Groups: Trimodulin, Placebo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the geographical scope of this investigation in Canada?

"This study is being conducted in four distinct locations, such as Butte's Investigational site # 1005, Prague's Investigational site # 4201, Timişoara's Investigational site # 4002; plus another quartet of sites."

Answered by AI

Is there available space for participants in this experiment?

"Clinicaltrials.gov reveals that this study, which was initially listed on June 20th 2023, is currently in search of participants. It was most recently updated on June 12th the same year."

Answered by AI

What is the current capacity of this investigation?

"Affirmative, the information available on clinicaltrials.gov evinces that enrollment is now open in this study which was initially posted on 20th June 2023 and updated as recently as 12th June 2023. The trial seeks to recruit 590 participants from 4 sites."

Answered by AI

To what degree can Trimodulin be detrimental to human health?

"A score of 3 was assigned to Trimodulin's safety due to the evidence from its Phase 3 clinical trial, with multiple rounds demonstrating both efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)

2023. "Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05722938.