Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects

Pseudomonas Aeruginosa Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696902
• Other study ID #: D5470C00004
• Status: Completed
• Phase: Phase 2
• Start date: March 25, 2016
• Est. completion date: December 4, 2019

Study information

• Verified date: January 2021
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: December 4, 2019
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthcare-Associated Pneumonia
• Pneumonia
• Pseudomonas Aeruginosa
• Pseudomonas Infections

Intervention

Drug:
• MEDI3902
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.

Other:
• Placebo
Participants will receive a single IV dose of placebo matched to MEDI3902.

Locations

Country	Name	City	State
Austria	Research Site	Innsbruck
Austria	Research Site	Wien
Belgium	Research Site	Bruges
Belgium	Research Site	Brussels
Belgium	Research Site	Brussels
Belgium	Research Site	Genk
Belgium	Research Site	Gent
Belgium	Research Site	Haine-Saint-Paul
Belgium	Research Site	Ottignies
Croatia	Research Site	Slavonski Brod
Czechia	Research Site	Brno
Czechia	Research Site	Decin
Czechia	Research Site	Kolin
Czechia	Research Site	Kyjov
Czechia	Research Site	Teplice
France	Research Site	Argenteuil
France	Research Site	Clermont-ferrand
France	Research Site	Garches
France	Research Site	La Tronche
France	Research Site	Le Kremlin Bicetre
France	Research Site	Le Plessis Robinson
France	Research Site	Lille Cedex
France	Research Site	Limoges
France	Research Site	Montpellier Cedex 5
France	Research Site	Nancy
France	Research Site	Paris
France	Research Site	Paris
France	Research Site	Paris
France	Research Site	Paris Cedex 14
France	Research Site	Pierre Benite
France	Research Site	Strasbourg
France	Research Site	Tours
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Larissa
Greece	Research Site	Larissa
Greece	Research Site	Thessaloniki
Hungary	Research Site	Budapest
Hungary	Research Site	Kistarcsa
Hungary	Research Site	Vác
Ireland	Research Site	Dublin
Israel	Research Site	Jerusalem
Israel	Research Site	Petach-Tikva
Israel	Research Site	Ramat Gan
Israel	Research Site	Tel Aviv
Portugal	Research Site	Almada
Portugal	Research Site	Lisboa
Portugal	Research Site	Lisboa
Portugal	Research Site	Viana do Castelo
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Cordoba
Spain	Research Site	Getafe
Spain	Research Site	Madrid
Spain	Research Site	Oviedo
Spain	Research Site	San Sebastián de los Reyes
Spain	Research Site	Santander
Spain	Research Site	Tarragona
Spain	Research Site	Terrassa
Spain	Research Site	Valencia
Spain	Research Site	Valladolid
Turkey	Research Site	Ankara
Turkey	Research Site	Istanbul
Turkey	Research Site	Trabzon
United Kingdom	Research Site	Edgbaston
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United States	Research Site	Annapolis	Maryland
United States	Research Site	Atlanta	Georgia
United States	Research Site	Augusta	Georgia
United States	Research Site	Boston	Massachusetts
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Detroit	Michigan
United States	Research Site	Englewood	Colorado
United States	Research Site	Gainesville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
MedImmune LLC	Antibacterial Resistance Leadership Group, INNOVATIVE MEDICINES INITIATIVE and COMBACTE-MAGNET, National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Croatia,  Czechia,  France,  Greece,  Hungary,  Ireland,  Israel,  Portugal,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa	Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.	Day 1 through Day 22
Primary	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.	Day 1 through Day 50
Primary	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.	Day 1 through Day 50
Primary	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.	Day 1 through Day 50
Secondary	Maximum Observed Concentration (Cmax) of MEDI3902	The Cmax of MEDI3902 is reported.	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
Secondary	Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902	The AUC0-inf of MEDI3902 is reported.	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
Secondary	Clearance (CL) of MEDI3902	The CL of MEDI3902 from body after intrevanous administration of single dose is reported.	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
Secondary	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.	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, and Day 22
Secondary	Terminal Elimination Half-life (t1/2) of MEDI3902	The t1/2 of MEDI3902 is reported.	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
Secondary	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.	Day 1 (predose), Day 15, Day 29, Day 50

External Links

•   D5470C00004 Redacted SAP for CT.gov results
•   Redacted CSP for CT.gov results