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Tests treatment safety and results for Community-acquired Pneumonia
Official title Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
ClinicalTrials.gov ID: NCT05722938
What this study is testing
What is Trimodulin?
Trimodulin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for community-acquired pneumonia.
Also referred to as BT588.
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
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Main
- Written informed consent.
- Hospitalized, adult (≥ 18 years of age) subject.
- 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.
You likely can't join if
- For an incapacitated subject: any indication that the subject's presumed will would be against inclusion in the trial.
- Pregnant or lactating women.
- people of childbearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment.
- people on ECMO at start of IMP treatment.
- Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP).
- people discharged from hospital within the previous 14 days.
See the full eligibility criteria
- Main
- Written informed consent.
- Hospitalized, adult (≥ 18 years of age) subject.
- 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
- For an incapacitated subject: any indication that the subject's presumed will would be against inclusion in the trial.
- Pregnant or lactating women.
- people of childbearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment.
- people on ECMO at start of IMP treatment.
- Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP).
- people 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 treatment clinical trial within 30 days before start of IMP treatment, or previous treatment...
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Fresno, California, United States
- Sacramento, California, United States
- Augusta, Georgia, United States
- Lansing, Michigan, United States
- Royal Oak, Michigan, United States
- Columbia, Missouri, United States
- Hannibal, Missouri, United States
- Butte, Montana, United States
- Newark, New Jersey, United States
- Buffalo, New York, United States
- New York, New York, United States
- Winston-Salem, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- San Vicente, Córdoba Province, Argentina
+ 98 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
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 Mobile, Alabama, United States; Fresno, California, United States; Sacramento, California, United States; Augusta, Georgia, United States; Lansing, Michigan, United States; Royal Oak, Michigan, United States and 112 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.