Last updated 22 days ago
Efficacy and Safety of Trimodulin (BT588) in Subjects with Severe Community-acquired Pneumonia (sCAP)
590 patients around the world
Available in Argentina, Brazil
This is a randomized, placebo-controlled, double-blind, multi-center, multi-national,
phase III trial, to assess the efficacy and safety of trimodulin compared to placebo
treatment, as adjunctive treatment to SoC in adult hospitalized subjects with sCAP
receiving IMV.
Subjects will be randomized on a 1:1 basis to receive trimodulin or placebo, stratified
by center. Investigational medicinal product (IMP) treatments will be blinded.
Subject will be administered IMP once daily on 5 consecutive days (day 1 through day 5)
adjunctive to SoC. The subsequent follow-up phase comprises maximally 23 days (day 6
through day 28) followed by an end-of-follow-up visit/telephone call on day 29 [+3]. For
subjects still in the hospital (trial site) after day 29, an extended follow-up is
conducted until discharge or until day 90. For all subjects alive on day 29, a closing
visit/telephone call on day 91 [+10] will be done.
Biotest
18Research sites
590Patients around the world
This study is for people with
Pneumonia
Community-acquired Pneumonia
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Written informed consent.Hospitalized, adult (≥ 18 years of age) subject.Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) negative status.Signs of inflammation based on C-reactive protein threshold level.Diagnosis of active pneumonia.Radiological (or other imaging technology) evidence consistent with active pneumonia.Acute respiratory failure requiring IMV.
- For an incapacitated subject: any indication that the subject's presumed will would be against inclusion in the trial.Pregnant or lactating women.Subjects not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment.Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP).Diagnosis of COVID-19 during the last 4 weeks.Subjects that required oxygen therapy due to COVID-19 in the last 6 months.Defined neutrophil counts within 24 hours prior to start of IMP treatment.Defined platelet counts within 24 hours prior to start of IMP treatment.Defined hemoglobin within 24 hours prior to start of IMP treatment.Known hemolytic disease.Known thrombosis or thromboembolic events (TEEs) or known medical history of TEEs or subjects particularly at risk for TEEs.Subject on dialysis or with severe renal impairment within 24 hours prior to start of IMP treatment.Subject with end-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS).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).Known decompensated heart failure.Known pre-existing hepatic cirrhosis, severe hepatic impairment (Child Pugh score ≥ 9 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.Known treatment for thorax/head/neck/hematologic malignancies in the last 12 months before screening.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.Known treatment with polyvalent immunoglobulin preparations, plasma, or albumin preparations during the last 21 days before screening.Known treatment with predefined medications, during the last 5 days before screening.Any type of interferon during the last 21 days before screening.Ongoing treatment with immunosuppressants other than guideline recommended immunosuppressants for treatment of active pneumonia.Participation in another interventional clinical trial within 30 days before screening or previous participation in this clinical trial.
Sites
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Estudios Clínicos de los Arroyos
Recruiting
Clínica Privada Chutro SRL - Córdoba
Recruiting
Nuevo Hospital San Roque - Córdoba
Recruiting
Sanatorio de la Cañada
Recruiting
Sanatorio De la Cañada
Recruiting
Sanatorio Privado Parque - Córdoba
Recruiting
Sanatorio de la Trinidad Mitre - CABA
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
StudyESsCAPE
SponsorBiotest
Conditions
Community-acquired Pneumonia
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05722938
