severe Community Acquired Pneumonia (sCAP) MedDRA version: 14.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia System Organ Class: 100000004862
Conditions
Interventions
Product Name: IgM Concentrate
Product Code: BT086
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: IgM Concentrate
Current Sponsor code: BT086
Other descriptive name: HUMAN NORMAL IMMUN
Sponsors
Biotest AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent: • given by the patient or • a legal/authorised representative of the patient or • a waiver for written informed consent due to emergency situation, in compliance with all local legal requirements. 2. Male or female patients aged 18 years or older 3. Patient receiving adequate antibiotic treatment for pneumonia 4. Prior to endotracheal ventilation and therapy, the patient must have at least one of the following two signs of inflammation: • Fever/Hypothermia Fever defined as an oral, tympanic, oesophageal, or vesical temperature of >38°C, or rectal temperature of >38.5°C, or hypothermia (rectal temperature 10,000/mm³ or WBC 20 breaths/minute) • Pleuritic chest pain • Auscultatory findings on pulmonary examination of rales and/or crackles and/or evidence of pulmonary consolidation (e.g. dullness on percussion, bronchial breath sounds, or egophony) 6. Radiological (or other imaging technique) evidence of (an) infiltrate(s) consistent with bacterial pneumonia 7. Pneumonia has been acquired outside the hospital. In hospital-admitted patients, pneumonia has been diagnosed a maximum of 72 hours after admission. Patients from nursing homes or similar institutions are eligible. 8. Major sCAP criterion: need for endotracheal ventilation 9. Treatment of patient with BT086 must start within 12 hours but not earlier than 1 hour after start of endotracheal ventilation Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. For incapacitated patients: any indication that the patient’s presumed will would be against inclusion in the trial 2. Patients with suspected hospital-acquired pneumonia 3. Severe lung diseases interfering with sCAP therapy e.g. patients with cystic fibrosis, 4. Patients receiving Xigris® (drotrecogin alfa, activated Protein C) or medications not approved for sCAP (e.g. Dornase alpha) are excluded from inclusion in the study 5. Patients on dialysis 6. Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing uncorrectable medical condition). 7. Patients unable to be treated due to obesity 8. Selective, absolute IgA deficiency with known antibodies to IgA 9. Patients with neutrophil count <1,000/mm³ or platelet count <50,000/mm³ 10. Pregnant or lactating women. A pregnancy test will be performed in all women aged <65 years and the result must be available at study inclusion. 11. Known relevant intolerance to immunoglobulins, vaccines or other substances of human origin 12. Participation in another interventional clinical trial within 30 days before entering the study or during the study, and/or previous participation in this study (participation in non-interventional trials is allowed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective of this clinical phase II trial is to evaluate the efficacy (ventilator free days) of BT086 IgM concentrate in patients with sCAP (severe community acquired pneumonia);Secondary Objective: Secondary objectives of this clinical phase II trial are to demonstrate repeated dose safety, tolerability, pharmacodynamic and pharmacokinetics of BT086 intravenous administration. Pharmacodynamics: Evaluation of complement system (6 patients) and Procalcitonin and C-reactive protein (CRP) Pharmacokinetics (PK): Evaluation of IgM and serum concentration of IgM, IgA, IgG in approximately 20 patients Evaluation of safety and tolerability in terms of: • Infusion-related reactions • Adverse events (AEs) • Vital signs • Electrocardiogram (ECG) • Safety laboratory ;Primary end point(s): The primary endpoint is the increase of ventilator free days (VFDs) measured in sCAP patients treated with adjunctive BT086 and the appropriate standard of care treatment compared to patients treated with placebo and the appropriate standard of care. ;Timepoint(s) of evaluation of this end point: Within 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Furthermore the following secondary endpoints will be assessed. • VFDs in surviving patients • 28-day all cause mortality • 28-day pneumonia cause mortality • Time to discharge from ICU (intensive care unit) • Time to discharge from hospital • SOFA score • Glasgow coma score • Vasopressor-free days ;Timepoint(s) of evaluation of this end point: Within 28 days | — |
Countries
Belgium, Germany, Spain, United Kingdom
Contacts
Public ContactClinical Trial Information
Biotest AG
Outcome results
None listed