RECRUITING

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

Conditions

Community-acquired Pneumonia Severe Community-acquired Pneumonia

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2023-09-09

Study Completion:2025-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05722938

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Written informed consent. 2. Hospitalized, adult (≥ 18 years of age) subject. 3. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) negative status. 4. Signs of inflammation based on C-reactive protein threshold level. 5. Diagnosis of active pneumonia. 6. Radiological (or other imaging technology) evidence consistent with active pneumonia. 7. Acute respiratory failure requiring IMV.	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 not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment. 4. Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP). 5. Diagnosis of COVID-19 during the last 4 weeks. 6. Subjects that required oxygen therapy due to COVID-19 in the last 6 months. 7. Defined neutrophil counts within 24 hours prior to start of IMP treatment. 8. Defined platelet counts within 24 hours prior to start of IMP treatment. 9. Defined hemoglobin within 24 hours prior to start of IMP treatment. 10. Known hemolytic disease. 11. Known thrombosis or thromboembolic events (TEEs) or known medical history of TEEs or subjects particularly at risk for TEEs. 12. Subject on dialysis or with severe renal impairment within 24 hours prior to start of IMP treatment. 13. Subject with end-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS). 14. Known severe lung diseases interfering with sCAP therapy (e.g., subjects with chronic obstructive pulmonary disease \[COPD\], severe interstitial lung disease \[incl. idiopathic pulmonary fibrosis\], cystic fibrosis, active tuberculosis, chronically infected bronchiectasis, or active lung cancer). 15. Known decompensated heart failure. 16. Known pre-existing hepatic cirrhosis, severe hepatic impairment (Child Pugh score ≥ 9 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. Known treatment for thorax/head/neck/hematologic malignancies in the last 12 months before screening. 20. 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. 21. Morbid obesity with high body mass index (BMI) ≥ 40 kg/m2, or malnutrition with low BMI \< 16 kg/m2. 22. Known treatment with polyvalent immunoglobulin preparations, plasma, or albumin preparations during the last 21 days before screening. 23. Known treatment with predefined medications, during the last 5 days before screening. 24. Any type of interferon during the last 21 days before screening. 25. Ongoing treatment with immunosuppressants other than guideline recommended immunosuppressants for treatment of active pneumonia. 26. Participation in another interventional clinical trial within 30 days before screening or previous participation in this clinical trial.

Inclusion Criteria

Exclusion Criteria

1. Written informed consent.
2. Hospitalized, adult (≥ 18 years of age) subject.
3. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) negative status.
4. Signs of inflammation based on C-reactive protein threshold level.
5. Diagnosis of active pneumonia.
6. Radiological (or other imaging technology) evidence consistent with active pneumonia.
7. Acute respiratory failure requiring IMV.

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 not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment.
4. Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP).
5. Diagnosis of COVID-19 during the last 4 weeks.
6. Subjects that required oxygen therapy due to COVID-19 in the last 6 months.
7. Defined neutrophil counts within 24 hours prior to start of IMP treatment.
8. Defined platelet counts within 24 hours prior to start of IMP treatment.
9. Defined hemoglobin within 24 hours prior to start of IMP treatment.
10. Known hemolytic disease.
11. Known thrombosis or thromboembolic events (TEEs) or known medical history of TEEs or subjects particularly at risk for TEEs.
12. Subject on dialysis or with severe renal impairment within 24 hours prior to start of IMP treatment.
13. Subject with end-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS).
14. Known severe lung diseases interfering with sCAP therapy (e.g., subjects with chronic obstructive pulmonary disease \[COPD\], severe interstitial lung disease \[incl. idiopathic pulmonary fibrosis\], cystic fibrosis, active tuberculosis, chronically infected bronchiectasis, or active lung cancer).
15. Known decompensated heart failure.
16. Known pre-existing hepatic cirrhosis, severe hepatic impairment (Child Pugh score ≥ 9 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. Known treatment for thorax/head/neck/hematologic malignancies in the last 12 months before screening.
20. 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.
21. Morbid obesity with high body mass index (BMI) ≥ 40 kg/m2, or malnutrition with low BMI \< 16 kg/m2.
22. Known treatment with polyvalent immunoglobulin preparations, plasma, or albumin preparations during the last 21 days before screening.
23. Known treatment with predefined medications, during the last 5 days before screening.
24. Any type of interferon during the last 21 days before screening.
25. Ongoing treatment with immunosuppressants other than guideline recommended immunosuppressants for treatment of active pneumonia.
26. Participation in another interventional clinical trial within 30 days before screening or previous participation in this clinical trial.

Contacts and Locations

Study Contact

Iris Bobenhausen, PhD

CONTACT

+4915222801073

iris.bobenhausen@biotest.com

Claudia Schulte

CONTACT

+4915222801491

claudia.schulte@biotest.com

Principal Investigator

Ricard Ferrer Roca, Dr.

PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebron

Study Locations (Sites)

Pulmonary Associates of Mobile, P.C.

Mobile, Alabama, 36608

United States

University of California San Francisco-Fresno

Fresno, California, 93701

United States

UC Davis Health

Sacramento, California, 95817

United States

Augusta University

Augusta, Georgia, 30912

United States

Sparrow Clinical Research Institute

Lansing, Michigan, 48912

United States

William Beaumont Hospital

Royal Oak, Michigan, 48073

United States

University of Missouri Clinical Research Center

Columbia, Missouri, 65212

United States

Hannibal Clinic

Hannibal, Missouri, 63401

United States

Mercury Street Medical Group

Butte, Montana, 59701

United States

St. Michael's Medical Center

Newark, New Jersey, 07102

United States

Buffalo VA Medical Center

Buffalo, New York, 14215

United States

Lenox Hill Hospital

New York, New York, 10075-1850

United States

Wake Forest Baptist

Winston-Salem, North Carolina, 27157

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Jefferson University Hospitals

Philadelphia, Pennsylvania, 19107

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Medical City Fort Worth

Fort Worth, Texas, 76104

United States

University of Utah

Salt Lake City, Utah, 84108

United States

Collaborators and Investigators

Sponsor: Biotest

Ricard Ferrer Roca, Dr., PRINCIPAL_INVESTIGATOR, Hospital Vall d'Hebron

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-09

Study Completion Date2025-04-30

Study Record Updates

Study Start Date2023-09-09

Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

Severe Community-acquired Pneumonia

Additional Relevant MeSH Terms

Community-acquired Pneumonia