Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
188
Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa
Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.
Time frame: Day 1 through Day 22
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The 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 50
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
An 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.
Time frame: Day 1 through Day 50
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
An AESI is one of scientific and medical interest specific event for understanding of the study drug and may require close monitoring and rapid communication by the investigator to the sponsor. An AESI may be serious or non-serious.
Time frame: Day 1 through Day 50
Maximum Observed Concentration (Cmax) of MEDI3902
The Cmax of MEDI3902 is reported.
Time frame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902
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Research Site
Englewood, Colorado, United States
Research Site
Gainesville, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Augusta, Georgia, United States
Research Site
Annapolis, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Detroit, Michigan, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Innsbruck, Austria
Research Site
Vienna, Austria
...and 68 more locations
The AUC0-inf of MEDI3902 is reported.
Time frame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
Clearance (CL) of MEDI3902
The CL of MEDI3902 from body after intrevanous administration of single dose is reported.
Time frame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose
Percentage of participants maintaining MEDI3902 serum levels above the target level (1.7 µg/mL) through 21 days post dose is reported.
Time frame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, and Day 22
Terminal Elimination Half-life (t1/2) of MEDI3902
The t1/2 of MEDI3902 is reported.
Time frame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 Treatment
Number of participants with positive ADA to MEDI3902 treatment is reported. Persistent positive is defined as positive at \>= 2 post-baseline assessments or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at \>= 2 post-baseline assessments.
Time frame: Day 1 (predose), Day 15, Day 29, Day 50