Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
213
Percentage of Participants With Endpoint Adjudication Committee-Determined (EAC) Staphylococcus Aureus (S Aureus) Pneumonia
The EAC S aureus pneumonia was based on clinical, radiographic, and microbiologic criteria. Clinical criteria: 1 major criteria (PaO2/FiO2 ratio \< 240 mmHg maintained for at least 4 hours or decrease in PaO2/FiO2 by \>= 50 mmHg maintained for at least 4 hrs or a need to initiate non-invasive mechanical ventilation or re-initiate invasive mechanical ventilation because of respiratory failure or worsening of respiratory status); and at least 2 of minor criteria (systemic signs of infection, production of purulent sputum/endotracheal secretions, new onset of cough, physical examination findings consistent with pneumonia/pulmonary consolidation, dyspnea, and/or tachypnea). Radiographic criteria: new or worsening infiltrate consistent with pneumonia on chest X-ray obtained within 24 hrs of event. Microbiologic criteria: at least 1 culture positive for S aureus (respiratory specimen, or blood, or pleural fluid aspirate or lung tissue culture during episode of pneumonia).
Time frame: Day 1 through Day 31
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Through 31 Days
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time frame: Day 1 through Day 31
Number of Participants With TEAEs Through 91 Days
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time frame: Day 1 through Day 91
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
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Research Site
Atlanta, Georgia, United States
Research Site
Detroit, Michigan, United States
Research Site
Arlon, Belgium
Research Site
Brussels, Belgium
Research Site
La Louvière, Belgium
Research Site
Lodelinsart, Belgium
Research Site
Yvoir, Belgium
Research Site
Brno, Czechia
Research Site
Děčín, Czechia
Research Site
Kyjov, Czechia
...and 39 more locations
Time frame: Day 1 through Day 191
Number of Participants With Adverse Events of Special Interest (AESIs)
An AESI is one of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. An AESI may have been serious or non-serious.
Time frame: Day 1 through Day 191
Number of Participants With New Onset Chronic Diseases (NOCDs)
An NOCD defined as a newly diagnosed medical condition that is of a chronic, ongoing nature. It is observed after receiving the study drug and is assessed by the investigator as medically significant.
Time frame: Day 1 through Day 191
Maximum Observed Serum Concentration (Cmax) of MEDI4893
Maximum observed serum concentration (Cmax) of MEDI4893 is reported.
Time frame: Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, 31, 61, and 91
Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0-Last]) of MEDI4893
Area under the serum concentration time curve from time zero to last measurable concentration (AUC\[0 - Last\]) of MEDI4893 is reported.
Time frame: Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, 31, 61, and 91
Observed Serum Concentration of MEDI4893 Through 30 Days Post Dose (C30)
Observed serum concentration of MEDI4893 through 30 days post dose (C30) is reported. Serum concentration of MEDI4893 through 30 days post dose accounted the overall concentration of MEDI4893 measured on specified time points (Days 1, 4, 8, 15, 22, and 30).
Time frame: Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, and 30
Observed Serum Concentration of MEDI4893 Through 90 Days Post Dose (C90)
Observed serum concentration of MEDI4893 through 90 days post dose (C90) is reported. Serum concentration of MEDI4893 through 90 days post dose accounted the overall concentration of MEDI4893 measured on specified time points (Days 1, 4, 8, 15, 22, 31, 61, and 91).
Time frame: Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, 31, 61, and 90
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to MEDI4893
Participants with ADA-positive at any of Day 31, Day 61, or Day 91 post-baseline assessments were always counted as "positive" at post-baseline.
Time frame: Pre-dose on Day 1 (Baseline); and on Days 31, 61, and 91