Back to resultsEffort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects (EVADE)
Primary Purpose
Pseudomonas Aeruginosa
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MEDI3902
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Pseudomonas Aeruginosa focused on measuring Pseudomonas aeruginosa, Pneumonia
Eligibility Criteria
Inclusion Criteria:
Colonized with P aeruginosa, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.
Exclusion Criteria:
P aeruginosa disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently receiving protocol-specified Anti-P aeruginosa antibiotics, moribund participants.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
MEDI3902 500 mg
Placebo
MEDI3902 1500 mg
Arm Description
Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902.
Participants will receive a single IV dose of placebo matched to MEDI3902.
Participants will receive a single IV dose of 1500 mg MEDI3902.
Outcomes
Primary Outcome Measures
Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa
Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.
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.
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.
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.
Secondary Outcome Measures
Maximum Observed Concentration (Cmax) of MEDI3902
The Cmax of MEDI3902 is reported.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902
The AUC0-inf of MEDI3902 is reported.
Clearance (CL) of MEDI3902
The CL of MEDI3902 from body after intrevanous administration of single dose is reported.
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.
Terminal Elimination Half-life (t1/2) of MEDI3902
The t1/2 of MEDI3902 is reported.
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.
Full Information
NCT ID
NCT02696902
First Posted
February 11, 2016
Last Updated
January 19, 2021
Sponsor
MedImmune LLC
Collaborators
INNOVATIVE MEDICINES INITIATIVE and COMBACTE-MAGNET, Antibacterial Resistance Leadership Group, National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT02696902
Brief Title
Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects
Acronym
EVADE
Official Title
A Phase 2 Proof-of-concept Study to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 25, 2016 (Actual)
Primary Completion Date
December 4, 2019 (Actual)
Study Completion Date
December 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC
Collaborators
INNOVATIVE MEDICINES INITIATIVE and COMBACTE-MAGNET, Antibacterial Resistance Leadership Group, National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudomonas Aeruginosa
Keywords
Pseudomonas aeruginosa, Pneumonia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDI3902 500 mg
Arm Type
Experimental
Arm Description
Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single IV dose of placebo matched to MEDI3902.
Arm Title
MEDI3902 1500 mg
Arm Type
Experimental
Arm Description
Participants will receive a single IV dose of 1500 mg MEDI3902.
Intervention Type
Drug
Intervention Name(s)
MEDI3902
Intervention Description
Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will receive a single IV dose of placebo matched to MEDI3902.
Primary Outcome Measure Information:
Title
Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa
Description
Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.
Time Frame
Day 1 through Day 22
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
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
Title
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Description
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
Title
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
Description
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
Secondary Outcome Measure Information:
Title
Maximum Observed Concentration (Cmax) of MEDI3902
Description
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
Title
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902
Description
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
Title
Clearance (CL) of MEDI3902
Description
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
Title
Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose
Description
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
Title
Terminal Elimination Half-life (t1/2) of MEDI3902
Description
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
Title
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 Treatment
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Colonized with P aeruginosa, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.
Exclusion Criteria:
P aeruginosa disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently receiving protocol-specified Anti-P aeruginosa antibiotics, moribund participants.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MedImmune LLC
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Research Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Research Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Research Site
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Research Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1080
Country
Austria
Facility Name
Research Site
City
Bruges
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Research Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Haine-Saint-Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Research Site
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Research Site
City
Slavonski Brod
ZIP/Postal Code
35000
Country
Croatia
Facility Name
Research Site
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Research Site
City
Decin
ZIP/Postal Code
405 99
Country
Czechia
Facility Name
Research Site
City
Kolin
ZIP/Postal Code
280 02
Country
Czechia
Facility Name
Research Site
City
Kyjov
ZIP/Postal Code
697 01
Country
Czechia
Facility Name
Research Site
City
Teplice
ZIP/Postal Code
415 29
Country
Czechia
Facility Name
Research Site
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Research Site
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Research Site
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
Research Site
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Research Site
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Research Site
City
Le Plessis Robinson
ZIP/Postal Code
92350
Country
France
Facility Name
Research Site
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Research Site
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Research Site
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Research Site
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Research Site
City
Paris Cedex 14
ZIP/Postal Code
75014
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
Research Site
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Research Site
City
Strasbourg
ZIP/Postal Code
67090
Country
France
Facility Name
Research Site
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Research Site
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11521
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
14233
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
14564
Country
Greece
Facility Name
Research Site
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Research Site
City
Larissa
ZIP/Postal Code
41221
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
54634
Country
Greece
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Research Site
City
Kistarcsa
ZIP/Postal Code
02143
Country
Hungary
Facility Name
Research Site
City
Vác
ZIP/Postal Code
2600
Country
Hungary
Facility Name
Research Site
City
Dublin
ZIP/Postal Code
6
Country
Ireland
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Research Site
City
Petach-Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Research Site
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Research Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Research Site
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1449-005
Country
Portugal
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Research Site
City
Viana do Castelo
ZIP/Postal Code
4904-858
Country
Portugal
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Getafe
ZIP/Postal Code
28905
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Research Site
City
San Sebastián de los Reyes
ZIP/Postal Code
28702
Country
Spain
Facility Name
Research Site
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Research Site
City
Tarragona
ZIP/Postal Code
43007
Country
Spain
Facility Name
Research Site
City
Terrassa
ZIP/Postal Code
08221
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Research Site
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Research Site
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Research Site
City
Edgbaston
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
36380312
Citation
Chastre J, Francois B, Bourgeois M, Komnos A, Ferrer R, Rahav G, De Schryver N, Lepape A, Koksal I, Luyt CE, Sanchez-Garcia M, Torres A, Eggimann P, Koulenti D, Holland TL, Ali O, Shoemaker K, Ren P, Sauser J, Ruzin A, Tabor DE, Akhgar A, Wu Y, Jiang Y, DiGiandomenico A, Colbert S, Vandamme D, Coenjaerts F, Malhotra-Kumar S, Timbermont L, Oliver A, Barraud O, Bellamy T, Bonten M, Goossens H, Reisner C, Esser MT, Jafri HS; COMBACTE-MAGNET EVADE Study Group. Safety, efficacy, and pharmacokinetics of gremubamab (MEDI3902), an anti-Pseudomonas aeruginosa bispecific human monoclonal antibody, in P. aeruginosa-colonised, mechanically ventilated intensive care unit patients: a randomised controlled trial. Crit Care. 2022 Nov 15;26(1):355. doi: 10.1186/s13054-022-04204-9.
Results Reference
derived
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5470C00004&attachmentIdentifier=4b147617-87bc-4d06-bbb6-af4264ed0f66&fileName=CSP_EVADE_D5470C00004-Amendment_3_REDACTED_FINAL_01Dec20.pdf&versionIdentifier=
Description
Redacted CSP for CT.gov results
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5470C00004&attachmentIdentifier=0f441439-cf44-426d-8bde-f105d6c56781&fileName=D5470C00004_SAP_FINAL_v3.0_approved_REDACTED_FINAL_01Dec20.docx.pdf&versionIdentifier=
Description
D5470C00004 Redacted SAP for CT.gov results
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Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects
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