NCT05722938 Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
| NCT ID | NCT05722938 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Biotest |
| Condition | Community-acquired Pneumonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 590 participants |
| Start Date | 2023-09-09 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 590 participants in total. It began in 2023-09-09 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Ricard Ferrer Roca, Dr.
PRINCIPAL INVESTIGATOR
Hospital Vall d'Hebron
Frequently Asked Questions
Who can join the NCT05722938 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Community-acquired Pneumonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05722938 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 590 participants.
Is NCT05722938 currently recruiting?
Yes, NCT05722938 is actively recruiting participants. Contact the research team at patrick.langohr@biotest.com for enrollment information.
Where is the NCT05722938 trial being conducted?
This trial is being conducted at Mobile, United States, Fresno, United States, Sacramento, United States, Augusta, United States and 11 additional locations.
Who is sponsoring the NCT05722938 clinical trial?
NCT05722938 is sponsored by Biotest. The principal investigator is Ricard Ferrer Roca, Dr. at Hospital Vall d'Hebron. The trial plans to enroll 590 participants.