The purpose of this study is to determine whether the adjunctive therapy to standard antibiotic treatment of BT086 is safe and effective of decreasing the days patients require endotracheal ventilation due to Severe Community-Acquired Pneumonia (sCAP).
Severe Community-Acquired Pneumonia (sCAP) is usually defined clinically as pneumonia acquired from outside the hospital (CAP) that requires intensive medical care. Mortality of (s)CAP patients admitted to ICU range from 35-58% depending on time and admission of the patient and has not much improved in the last years. BT086 contains a sufficient number of antibodies against the most frequent pathogens as well as antibodies against lipopolysaccharides and lipid A. Therefore, it can be assumed that administration of BT086 early in the clinical course of a severe infection such as sCAP may provide an effective adjunctive treatment to standard antibiotic therapy for sCAP patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
BT086 will be administered per intravenous infusion (IV). The dose to be administered is 3.65 mL /kg bw/day and is calculated by the mean Immunoglobulin M (IgM) content of BT086 which is 23%. Infusion rate: Starting rate is 0.1 mL/min. Maximum infusion rate is 0.5 mL/min (target infusion rate) Treatment will be administered over a 5-day period.
1% Albumin will be administered per intravenous infusion (IV). The dose to be administered is 3.65 mL /kg bw/day. Infusion rate:Starting rate is 0.1 mL/min. Maximum infusion rate is 0.5 mL/min (target infusion rate). Rate is to be raised in steps of 0.1 mL every 10 min until the target infusion rate is reached. Treatment will be administered over a 5-day period. Starting rate is 0.1 mL/min. Maximum infusion rate is 0.5 mL/min (target infusion rate)
401
Brussels, Belgium
Ventilator Free Days (VFDs)
VFDs are defined as the number of days between successful weaning from endotracheal ventilation and day 28 after study enrolment.
Time frame: 28 days
28-day all cause mortality
All patients will be classified as either "alive at Study Day 28" or, if dead, "dead at Study Day 28", regardless of cause of death.
Time frame: 28 days (672 hours from randomization)
28-day pneumonia-cause mortality
All patients will be classified as either "alive at Study Day 28" or, if dead, "dead at Study Day 28, with pneumonia as cause of death".
Time frame: 28 days (672 hours from randomization)
Time (days) to discharge from ICU
The date and time of admission to and discharge from the ICU will be recorded in the Case Report Form (CRF). The time to discharge from the ICU will be calculated as the number of days spent in the ICU.
Time frame: 28 days
Time (days) to discharge from hospital
The date and time of admission to and discharge from the hospital will be recorded in the CRF. The time to discharge from the hospital will be calculated as the number of days spent in the hospital.
Time frame: 28 days
SOFA: Score Sequential Organ Failure Assessment
Each organ system (cardiovascular, haematology, hepatic, renal, respiratory) will be scored using the SOFA methodology.For analysis, a patient will receive a score on each day (Study Days 1-7, Day 14, Day 21, and Day 28). Mean changes in organ function scores over time and percentages of patients whose organ function has resolved will be compared between treatment groups.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
108
Berlin, Germany
114
Chemnitz, Germany
118
Cologne, Germany
119
Cologne, Germany
110
Dresden, Germany
111
Erfurt, Germany
116
Frankfurt, Germany
117
Greifswald, Germany
103
Halle, Germany
...and 26 more locations
Time frame: 28 days
Vasopressor-free days
Vasopressor-free days will be calculated in a similar manner to VFDs, as described above. Vasopressors include dobutamine, epinephrine, dopamine, and norepinephrine. A day is considered as a vasopressor-free day if a patient does not receive * Dobutamine \>2.5 µg/kg/min or/and * Epinephrine (adrenalin) \>=2.5 µg/min or/and * Dopamine \>=2.5 µg/kg/min or/and * Norepinephrine \>=0.014 µg/kg/min for 4 hours per day.
Time frame: 28 days
Glasgow Coma Score
The Glasgow Coma Scale will be scored using the Glasgow Coma Score methodology. The patient will be assessed by calculating the score on each study day (Day -1 through to Day 28).
Time frame: 28 days