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RECRUITINGPhase 3INTERVENTIONAL

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

A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase III Trial to Assess the Efficacy and Safety of Trimodulin (BT588) in Adult Hospitalized Subjects With Severe Community-acquired Pneumonia (sCAP)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Main Who May Qualify: 1. Written willing to sign a consent form. 2. Hospitalized, adult (≥ 18 years of age) subject. 3. Signs of inflammation based on C-reactive protein threshold level. 4. Diagnosis of active community-acquired pneumonia (CAP) before hospital-admission or within 48 hours after admission. 5. Radiological (or other imaging technology) evidence consistent with active pneumonia. 6. Acute respiratory failure requiring IMV. Main Who Should NOT Join This Trial: 1. For an incapacitated subject: any indication that the subject's presumed will would be against inclusion in the trial. 2. Pregnant or lactating women. 3. Subjects of childbearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment. 4. Subjects on ECMO at start of IMP treatment. 5. Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP). 6. Subjects discharged from hospital within the previous 14 days. 7. Defined neutrophil counts up to one calendar day prior to start of IMP treatment. 8. Defined platelet counts up to one calendar day prior to start of IMP treatment. 9. Defined hemoglobin within up to one calendar day prior to start of IMP treatment. 10. Pre-existing hemolytic disease. 11. 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. 12. Severe renal impairment prior to start of IMP treatment. 13. End-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS). 14. Pre-existing severe lung diseases concomitant to current sCAP (e.g. active tuberculosis, active lung cancer). 15. Pre-existing decompensated heart failure. 16. Pre-existing severe hepatic cirrhosis (Child Pugh score ≥ 10 points), or severe hepatic impairment (Child Pugh score ≥ 10 points), or hepatocellular carcinoma. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Main Inclusion Criteria: 1. Written informed consent. 2. Hospitalized, adult (≥ 18 years of age) subject. 3. Signs of inflammation based on C-reactive protein threshold level. 4. Diagnosis of active community-acquired pneumonia (CAP) before hospital-admission or within 48 hours after admission. 5. Radiological (or other imaging technology) evidence consistent with active pneumonia. 6. Acute respiratory failure requiring IMV. Main Exclusion Criteria: 1. For an incapacitated subject: any indication that the subject's presumed will would be against inclusion in the trial. 2. Pregnant or lactating women. 3. Subjects of childbearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment. 4. Subjects on ECMO at start of IMP treatment. 5. Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP). 6. Subjects discharged from hospital within the previous 14 days. 7. Defined neutrophil counts up to one calendar day prior to start of IMP treatment. 8. Defined platelet counts up to one calendar day prior to start of IMP treatment. 9. Defined hemoglobin within up to one calendar day prior to start of IMP treatment. 10. Pre-existing hemolytic disease. 11. 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. 12. Severe renal impairment prior to start of IMP treatment. 13. End-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS). 14. Pre-existing severe lung diseases concomitant to current sCAP (e.g. active tuberculosis, active lung cancer). 15. Pre-existing decompensated heart failure. 16. Pre-existing severe hepatic cirrhosis (Child Pugh score ≥ 10 points), or severe hepatic impairment (Child Pugh score ≥ 10 points), or hepatocellular carcinoma. 17. Known intolerance to proteins of human origin or known allergic reactions to components of trimodulin / placebo. 18. Selective immunoglobulin A (IgA) deficiency with known antibodies to IgA. 19. 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. 20. Morbid obesity with high body mass index (BMI) ≥ 40 kg/m2, or malnutrition with low BMI \< 16 kg/m2. 21. Treatment with polyvalent immunoglobulin preparations during the last 21 days before start of IMP treatment. 22. Known treatment with predefined medications, during the last 2 days before start of IMP treatment. 23. Hematopoietic stem cell transplantation or previous lung transplantation. 24. 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.

Treatments Being Tested

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

Locations (20)

Pulmonary Associates of Mobile, P.C.
Mobile, Alabama, United States
University of California San Francisco-Fresno
Fresno, California, United States
UC Davis Health
Sacramento, California, United States
Augusta University
Augusta, Georgia, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
University of Missouri Clinical Research Center
Columbia, Missouri, United States
Hannibal Clinic
Hannibal, Missouri, United States
Mercury Street Medical Group
Butte, Montana, United States
St. Michael's Medical Center
Newark, New Jersey, United States
Buffalo VA Medical Center
Buffalo, New York, United States
Lenox Hill Hospital
New York, New York, United States
Wake Forest Baptist
Winston-Salem, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Jefferson University Hospitals
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Medical City Fort Worth
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Sanatorio Parque S.A. Privado
San Vicente, Córdoba Province, Argentina