NCT05722938 · Biotest
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
(ESsCAPE)
What this study is about
The main objective of the trial is to assess the effectiveness and safety of trimodulin as adjunctive treatment to the usual treatment (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV).
View original scientific description
The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV). Other objectives are to determine detailed pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.
Interventions
DRUG
Trimodulin
IMP will be administered via IV infusion on 5 consecutive days
DRUG
Placebo (human albumin 1%)
IMP will be administered via IV infusion on 5 consecutive days
Primary outcome measures
28-day all-cause mortality rate
Time frame: Between days 1-29
Percentage of subjects that died until day 29 regardless of cause of death
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Written informed consent.
- Hospitalized, adult (≥ 18 years of age) subject; In US only: ≥ 12 years of age
- Signs of inflammation based on C-reactive protein threshold level.
- Diagnosis of active community-acquired pneumonia (CAP) before hospital-admission or within 48 hours after admission.
- Radiological (or other imaging technology) evidence consistent with active pneumonia.
- Acute respiratory failure requiring IMV. Main
Exclusion criteria
- For an incapacitated subject: any indication that the subject's presumed will would be against inclusion in the trial.
- Pregnant or lactating women.
- Subjects of childbearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment.
- Subjects on ECMO at start of IMP treatment.
- Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP).
- Subjects discharged from hospital within the previous 14 days.
- Defined neutrophil counts up to one calendar day prior to start of IMP treatment.
- Defined platelet counts up to one calendar day prior to start of IMP treatment.
- Defined hemoglobin within up to one calendar day prior to start of IMP treatment.
- Pre-existing hemolytic disease.
- Thromboembolic events (TEEs) caused by other reasons than the current sCAP within 3 months before start of IMP treatment unless the risk for further TEEs can be adequately managed with standard prophylaxis or treatment.
- Severe renal impairment prior to start of IMP treatment.
- End-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS).
- Pre-existing severe lung diseases concomitant to current sCAP (e.g. active tuberculosis, active lung cancer).
- Pre-existing decompensated heart failure.
- Pre-existing severe hepatic cirrhosis (Child Pugh score ≥ 10 points), or severe hepatic impairment (Child Pugh score ≥ 10 points), or hepatocellular carcinoma.
- Known intolerance to proteins of human origin or known allergic reactions to components of trimodulin / placebo.
- Selective immunoglobulin A (IgA) deficiency with known antibodies to IgA.
- Life expectancy of less than 90 days, according to the investigator's clinical judgment, because of medical conditions related neither to sCAP nor to sCAP-associated septic conditions.
- Morbid obesity with high body mass index (BMI) ≥ 40 kg/m2, or malnutrition with low BMI \< 16 kg/m2.
- Treatment with polyvalent immunoglobulin preparations during the last 21 days before start of IMP treatment.
- Known treatment with predefined medications, during the last 2 days before start of IMP treatment.
- Hematopoietic stem cell transplantation or previous lung transplantation.
- Treatment with investigational medications/procedures not according to SoC of the trial site, due to participation in another interventional clinical trial within 30 days before start of IMP treatment, or previous treatment with IMP in this clinical trial.
Where
- Mobile, Alabama
- Phoenix, Arizona
- Fresno, California
- Sacramento, California
- Augusta, Georgia
- Baltimore, Maryland
- Boston, Massachusetts
- Lansing, Michigan
- Royal Oak, Michigan
- Columbia, Missouri
- Hannibal, Missouri
- Butte, Montana
And 14 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 14, 2026 · Source of record for eligibility and locations